*UPGRADE IN PROGRESS* -- CareerCircle platform upgrades will occur between Monday June 27th 10PM Eastern Time through Tuesday June 28th 4AM Eastern Time.&nbsp; The system may be intermittently unavailable during this timeframe.&nbsp;&nbsp;

*UPGRADE IN PROGRESS* -- CareerCircle is upgrading its capabilities and as a result the system may be temporarily unavailable as we bring new capabilities and infrastructure online to better serve our members.&nbsp; If you receive an error during this timeframe please bear with us as we're working to improve our system and you may need to retry that operation at a later time.&nbsp; &nbsp;

Job Description Position Description: Associate Clinical Research Associate - Northeast Region (Remote) With support of Senior Clinical Research Associate (SrCRA/CRA) and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.<ul><li>Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.</li><li>Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.</li><li>Gains an in-depth understanding of the study protocol and related procedures.</li><li>Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.</li><li>Participates & provides inputs on site selection and validation activities.</li><li>Performs remote and on-site monitoring & oversight activities using various tools to ensure:</li><li>o Data generated at site are complete, accurate and unbiased</li><li>o Subjects' right, safety and well-being are protected</li><li>Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.</li><li>Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.</li><li>Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.</li><li>Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.</li><li>Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites</li><li>Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.</li><li>Supports audit/inspection activities as needed.</li><li>Performs co-monitoring where appropriate.</li></ul>Extent of Travel<ul><li>Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling 2-3 days/week.</li><li>Current driver's license preferred.</li></ul> Position Qualifications: Education Minimum Requirement: <ul><li>B.A./B.S. required with strong emphasis in science and/or biology.</li><li>Min. 2 years of clinical research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC or similar.</li></ul>Required Experience and Skills: Competency Expectations:<ul><li>Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support.</li><li>Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.</li><li>Good understanding of Global, Country/Regional CRA Guidelines and ability to work within these guidelines.</li><li>Hands on knowledge of Good Documentation Practices</li><li>Developing skills in Site Management including management of site performance and patient recruitment</li><li>Developing level of monitoring skill and independent professional judgment.</li><li>Good IT skills (Use of MS office, use of some clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.</li><li>Works with high quality and compliance mindset.</li><li>Capable of managing complex issues, solution-oriented approach.</li><li>Ability to perform root cause analysis and implement preventative and corrective action.</li></ul>Behavioral Competency Expectations:<ul><li>Effective time management, organizational and interpersonal skills, conflict management</li><li>Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.</li><li>High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.</li><li>Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.</li><li>Demonstrates commitment to Customer focus.</li><li>Positive mindset, growth mindset, capable of working independently and being self-driven.</li><li>Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices</li></ul>MRLGCTO #EligibleforERP ETJOBS NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $75,400.00 - $118,700.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 50% Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: Yes Hazardous Material(s): Na Job Posting End Date: 05/24/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/24/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295722

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Associate Clinical Research Associate - Northeast Region (Remote)

Job Description Position Description: Associate Director, Technology Transfer (TT)Systems Group Leader As part of our Manufacturing Division , within Global Science Engineering & Commercialization, the Large Molecule Science and Technology (LMS&T) is accountable for Large Molecule Commercialization, Technical Product Leadership and Technical Operations. We are seeking a highly motivated individual for the role of Associate Director, Technology Transfer (TT) Systems Group Leader in Large Molecule Technology Transfer within Technical Product Leadership. This role will lead a team of scientists and engineers with a focus on end-to-end technical transfer systems (Standards, Playbook, Portal, Project Management) for technology transfers to all large molecules in pipeline and inline space. The incumbent will demonstrate a deep expertise for people management leadership and TT systems. The incumbent will have broad, experience-based skillsets in TT Standards, TT best practices and TT Project Management with key focus on standards and right first-time success for commercial scale manufacturing sciences/technology and in applicable business processes including program/portfolio management tools working with internal and external manufacturing partners. The incumbent will partner with groups across our Company and that includes the Global Human Health, Process Development, Commercialization, Operations, Technical Operations, Analytical, Quality, Regulatory-CMC, and Supply Chain. Associate Director is expected to contribute to ongoing business process improvements and all TT activities. Key Responsibilities:<ul><li>Manages and accountable for the overall TT Systems (Standards, Playbook, Portal, Project Management) activities.</li><li>Ensures all TT systems are maintained and continuously improved with appropriate oversight.</li><li>Responsible to manage TT systems team. May act as one of the systems lead as well.</li><li>Accountable to build and maintain project schedules and critical project information, using project management tools.</li><li>Ensure clear and effective communication with key team, management, and cross-departmental stakeholders.</li><li>Coach and manage team dynamics, empower, and develop employees to understand all aspects of TT systems and coaches TT systems team for best practices and continuous improvement mindset.</li><li>Ensure TT leads and systems team connectivity. Responsible to ensure TT learnings are incorporated into standards. </li><li>Ensures TT project management tools are maintained and schedules are met and are on time. Help support the commercialization and TPL resource forecasting and headcount activities to support financial budgeting cycles and resourcing decisions.</li><li>Improving business processes to find new efficiencies and connect people to the information that they need.</li><li>Develop and maintain training programs related to TT systems.</li><li>Required to comply with our company Global and regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.</li><li>Work collaboratively to drive a safe and compliant culture.</li></ul> Position Qualifications: Education Minimum Requirement: <ul><li>B.S. in Biological Sciences, Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with minimum of 7 years of relevant experience.</li></ul>Required Experience and Skills: Technical Capabilities:<ul><li>Expertise in technical aspects of product commercialization and life cycle management </li><li>Strong scientific knowledge of multiple TT types including vaccines / biologics drug substance, drug product and analytical.</li><li>Proficiency with validation section authoring and general BLA/MAA regulatory license documents.</li><li>Demonstrated creative problem-solving skill.</li><li>Strong knowledge of global regulatory guidelines and cGMP principles.</li><li>Demonstrated experience with lean operational excellence in manufacturing.</li><li>Digital tool competency with OnePMO, MS Teams, Power BI, MSPO, Spotfire, Share Points and other related systems.</li><li>Demonstrated ability to create and analyze detailed, cross-functional project plans (including Gantt charting) and manage execution and change against those plans.</li><li>Ability to identify and escalate TT systems risks.</li></ul> Leadership / Business Capabilities:<ul><li>Effective verbal and written communicator who keeps stakeholders / partners apprised of plans, status, and issues.</li><li>Works well in ambiguity.</li><li>Track record of motivating, mentoring and coaching teams.</li><li>Establishes clear goals, delegates effectively, holds self and others accountable.</li><li>Flexible and adaptable to dynamic situations.</li><li>Cross-functional team management; successful at indirect management.</li><li>Ability to succeed in a dynamic environment with flexibility to respond to changing priorities.</li><li>Effective interpersonal skills and ability to work collaboratively across diverse teams and networks; able to foster cooperation in others, using the diverse perspectives of others to generate ideas.</li><li>Well-developed and effective team facilitation and leadership skills; ability to establish inclusive team environments.</li></ul> NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 25% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 05/31/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/31/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R293527

Associate Director, TT Systems Group Leader

Job Description With support of Sr CRA (Clinical Research Associate) and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.<ul><li>Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.</li><li>Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. </li><li>Gains an in-depth understanding of the study protocol and related procedures.</li><li>Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.</li><li>Participates & provides inputs on site selection and validation activities.</li></ul>Performs remote and on-site monitoring & oversight activities using various tools to ensure:<ul><li>Data generated at site are complete, accurate and unbiased</li><li>Subjects' right, safety and well-being are protected</li><li>Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. </li><li>Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.</li><li>Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.</li><li>Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM (Clinical Research Manager), TA Head and CRD (Clinical Research Director) as needed. </li><li>Works in partnership with GCTO (Global Clinical Trial Operations) country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites</li><li>Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.</li><li>Supports audit/inspection activities as needed.</li><li>Performs co-monitoring where appropriate.</li></ul>Extent of Travel:<ul><li>Ability to travel domestically and internationally approximately 65%-75% of working time. </li><li>Expected travelling 2-3 days/week. </li><li>Current driver's license preferred.</li></ul>Qualifications, Skills & Experience Competency Expectations:<ul><li>Fluent in Local Languages and English (verbal and written) and excellent </li><li>communication skills, including the ability to understand technical information. Developing ability to present technical information with support.</li><li>Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines. </li><li>Good understanding of Global, Country/Regional CRA Guidelines and ability to work within these guidelines. </li><li>Hands on knowledge of Good Documentation Practices </li><li>Developing skills in Site Management including management of site performance and patient recruitment</li><li>Developing level of monitoring skill and independent professional judgment.</li><li>Good IT skills (Use of MS office, use of some clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.</li><li>Works with high quality and compliance mindset.</li><li>Capable of managing complex issues, solution-oriented approach.</li><li>Ability to perform root cause analysis and implement preventative and corrective action.</li></ul>Behavioral Competency Expectations:<ul><li>Effective time management, organizational and interpersonal skills, conflict </li><li>management</li><li>Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.</li><li>High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.</li><li>Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.</li><li>Demonstrates commitment to Customer focus.</li><li>Positive mindset, growth mindset, capable of working independently and being self-driven.</li><li>Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.</li></ul>Requirements:<ul><li>B.A./B.S. required with strong emphasis in science and/or biology. </li><li>Min. 2 years of clinical research experience. Related CR (Clinical Research) experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC (Clinical Trial Coordinator) or similar.</li></ul>MRLGCTO #EligibleforERP ETJOBS NOTICEFORINTERNALAPPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $75,400.00 - $118,700.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 50% Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: Yes Hazardous Material(s): NA Job Posting End Date: 05/24/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/24/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295855

Associate Clinical Research Associate - Louisiana, Arkansas, New Mexico and Oklahoma(REMOTE)

Job Description This position resides within Animal Health Outcomes Research, which leads value evidence strategy development and conducts research to inform veterinary healthcare decision making. As a member of the Outcomes Research Value team, this individual will develop value evidence strategies and tactics to support the Animal Health division. The position reports to the Director, our company's Outcomes Research. Position objectives: <ul><li>To inform and contribute to the value evidence strategy and associated studies which describe clinical, economic, and patient-centered unmet needs and the value the product provides in addressing those needs.</li><li>To design, execute and communicate results of observational research studies</li><li>To communicate findings from the research to relevant internal and external audiences</li><li>To generate value evidence including value dossiers, evidence synthesis, clinical trial analyses, economic modeling and patient-reported outcomes.</li><li>To support discussions with internal and external partners on value evidence strategies and plans for relevant study development and execution.</li></ul> Position accountabilities: <ul><li>To collaborate with internal stakeholders and consulting partners to ensure research priorities and strategies are aligned.</li><li>To communicate with relevant external audiences including veterinary health care providers, clinic staff, veterinary teaching programs, peer-reviewed journals and producers that focus on animal production.</li><li>To design and implement outcomes research studies, in collaboration with scientific leaders, veterinary medical centers, corporate veterinary health systems, research organizations, database holders and others.</li><li>To prepare outcomes research protocols, statistical analysis plans, clinical study reports and manuscripts intended for peer-review.</li><li>To ensure findings are communicated effectively at scientific conferences, in publications, dossiers, and by other channels.</li><li>To maintain awareness of scientific developments in the field and provide outcomes research leadership and consultation.</li><li>To provide expertise on observational study best practices, real world evidence frameworks, and internal standard operating procedures on the conduct of observational research.</li></ul> Education Minimum Requirement: <ul><li>Preferred: Doctoral degree (PhD, DrPH, ScD, PharmD) in relevant discipline (Health Services Research, Outcomes Research, Epidemiology, Public Health, Health Economics, Pharmacoeconomics, Pharmacy Administration).</li><li>Required: Master's degree (MSc, MPH) in relevant discipline (Health Services Research, Outcomes Research, Epidemiology, Public Health, Health Economics, Pharmacoeconomics, Pharmacy Administration).</li></ul> Required Experience and Skills: <ul><li>Expertise/experience in the design and implementation of real-world evidence.</li><li>A track record of scientific presentations, manuscript development and peer-reviewed publications.</li><li>A minimum of three (3) years of relevant experience post-graduation, with Doctoral degree</li><li>A minimum of five (5) of years relevant experience post-graduation, with Masters' degree only</li></ul> Preferred Experience and Skills: <ul><li>Doctoral degree or Masters Degree with appropriate experience.</li><li>Experience in Human or Animal Health-related Outcomes Research, Epidemiology or Health Economics.</li></ul>NOTICEFORINTERNALAPPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $181,600.00 - $285,800.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 05/31/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/31/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295458

Director, Principal Scientist - Animal Health Outcomes Research

Job Description Our Teknika Quality Assurance group ensures every single material inside our products is manufactured, tested, and distributed in alignment with our incredibly high standards of quality. The Quality Assurance Associate Director will provide critical support in Teknika's continued efforts with supplying the market though leading the Incoming Material Release and Sterility Assurance teams. These teams are key to Teknika's abilities to successfully operate with approved materials and under the appropriate conditions. Position Responsibilities: <ul><li>Reporting to the Director, Quality Assurance will independently manage team and assignments.</li><li>Ensure all assigned aspects of the incoming and operations process proceed in compliance with cGMP, applicable regulations, and our Company's Quality Management System.</li><li>Focus on ensuring facility and personnel remains in state of control based on Sterility Assurance requirements ensuring an integral process. </li><li>Lead a Quality team to provide QA support to assigned areas of focus including but not limited to quality risk management, strategy development, development/revision of standard operating procedures, compliance-based projects.</li><li>Lead, facilitate and participate on cross-functional teams to collaboratively address issues and achieve project milestones.</li><li>Actively sponsor and develop a culture that defines a High-Performing Organization including proactively providing developmental support, coaching and assistance to team members.</li><li>Review and approve documents as necessary including investigations, change controls, SOPs, validation protocols, technical reports.</li><li>Makes decisions guided by policies and procedures that impact the team's ability to meet performance objectives.</li><li>Escalates and consults on an as-needed basis with next level manager on more complex decisions impacting critical milestones.</li></ul> Education and Experience Requirement: <ul><li>Bachelor's degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline with seven (7) years' experience including prior management experience in a functional area, such as, Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or supply chain. OR</li><li>Master's degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline with five (5) years' experience including prior management experience in a functional area, such as, Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or supply chain.</li></ul> Required Experience and Skills: <ul><li>Effective decision making, problem solving and communication skills. </li><li>Ability to manage multiple priorities and complex problems in a fast-paced environment.</li><li>Aseptic manufacturing and GMP quality experience.</li><li>Experience with Quality Risk Management and strong contemporary knowledge of relevant current good manufacturing practices (cGMPs), regulations and current industry trends.</li></ul> Preferred Experience and Skills: <ul><li>Knowledge of Supplier Management and Incoming Release</li><li>Demonstrated Project Management Experience in a regulated industrial setting.</li></ul>NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 05/28/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/28/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R294152

Associate Director, Quality

Job Description *** THIS IS A HYBRID ROLE. AN ONSITE PRESENCE IS REQUIRED*** The Global Medical Information (GMI) Scientists for Oncology, with their advanced scientific background (PharmD, PhD, or MS in Life Sciences), are resources within their therapeutic area for the global core functions of Medical Information (e.g., customizing medical information letters to respond to U.S. HCP inquiries, handling of escalated complex global HCP inquiries, and insight generation/analysis), Medical Review of U.S. and HQ-created global Promotional Materials and Scientific Content, Medical Education and Training of internal stakeholders (e.g., U.S. Call Center, Field Sales), and Compendia and Pathways Submissions on our company's products and associated diseases. Our Oncology team is dedicated to delivering breakthrough innovations that extend and improve the lives of cancer patients worldwide. Our team of forward-thinking individuals achieve this through an unwavering commitment to support accessibility to medicine, providing new therapeutic solutions, and collaborating with governments and payers to ensure that people who need medicines have access to them. Our focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people with cancer across the globe. Primary Responsibilities:<ul><li>Has a deep understanding of therapeutic area, including product knowledge, disease state management, emerging therapies, and the competitive landscape. Apply developed depth and breadth of disease, product and process expertise, and help solve unique and complex problems/inquiries specific to the brands within and beyond areas of expertise, across team.</li><li>Medical Information (MI): Customize responses to US inquiries from healthcare providers in writing and/or verbally. Respond to complex escalated global inquiries. Generate insights from MI capabilities to inform strategic planning and identify gaps in data and educate on scientific exchange for appropriate stakeholders. Staff medical information booths at HQ-sponsored US and international congresses to verbally answer unsolicited inquiries from HCPs.</li><li>Scientific/Medical Review of US and Global Promotional and Non-Promotional Materials: Independently review and approve promotional materials from internal Human Health (HH) teams and external partners and non-promotional materials from the Global Scientific Content (GSC) team to ensure content, claims, and/or comparisons are relevant, scientifically and medically accurate, balanced, provide appropriate context, and are consistent with cited appropriate scientific literature, internal scientific information, and all applicable company policies, local regulations, and department SOPs.</li><li>Medical Education and Training: Create and develop medical/disease education materials. Create/adapt foundational materials to use in disease and product scientific lectures to train internal stakeholders, including Field Sales representatives, Our Company National Service Center (call center), country medical colleagues, and United States Medical Affairs (USMA) field-based employees. Participate in training of promotional review standards and process for internal stakeholders.</li><li>Compendia and Pathways Submissions: Engage and collaborate with subject matter experts and relevant stakeholders in the planning, review, approval, and submission processes for Compendia and Pathways for applicable therapeutic area.</li><li>Leadership and Mentoring: Lead product-related projects/initiatives that directly impact the franchise/brand strategy and objectives to meet external customer needs. Lead departmental initiatives that impact GMI process improvements, drive the solution of complex problems through identification of innovative solutions, and foster cross-functional collaborations. Serve as a go-to person within the core functions for colleagues across stakeholder departments. Mentor/empower entry-level colleagues to develop within their functional roles. Mentor/precept pharmacy/PhD students, fellows, and residents.</li><li>Fully comply with all company policies and applicable laws, regulations, and ethical standards, and make decisions within guidelines and policies which impact a range of stakeholder/customer, operational, and project activities.</li></ul>Required Qualifications, Skills, & Experience: Minimum Requirements:<ul><li>Advanced Degree (PhD, PharmD, or equivalent) + minimum 2 years medical information, medical review of promotional materials, and/or prior biotech/pharmaceutical experience</li><li>MS in life sciences, nursing/medical field + minimum 3 years medical information, medical review of promotional materials, and/or prior biotech/pharmaceutical experience</li><li>Advanced knowledge and therapeutic area experience in Oncology</li><li>Relevant partnership/alliance experience with other pharmaceutical companies in medical information and/or medical review of promotional materials</li><li>Exhibited leadership and execution excellence via initiatives, mentoring, process improvements, and/or innovations</li><li>Strong knowledge of clinical trial methodology, statistical concepts, and evaluation and interpretation of complex scientific literature</li><li>Critical thinking skills and ability to consolidate and understand complex data sets</li><li>Strong medical communications (oral and written) and presentation skills</li><li>Demonstrated emotional intelligence and interpersonal skills with the ability to foster collaborations with all levels and roles in cross-functional global teams</li><li>Must be solution-oriented and able to plan, prioritize, and work effectively in a dynamic and changing environment</li><li>Ability to travel up to 5% of the time overnights to staff Medical Information Booths at worldwide congresses</li></ul>Preferred:<ul><li>More than 3 years experience in medical information medical review of promotional materials, and/or Compendia and Pathways submissions in the biotech/pharmaceutical industry</li><li>Strong working knowledge of Microsoft Office Suite, Veeva Vault Medical, and Veeva Vault PromoMats</li></ul>NOTICEFORINTERNALAPPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 06/1/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/01/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R294905

Global Medical Information Scientist, Associate Director (Oncology)

Job Description The Specialist, Operations supports manufacturing operations in the Vaccines HPV Bulk IPT organization. This high impact role in our Company assures that products manufactured comply with current Good Manufacturing Practice (cGMPs), operating procedures and other applicable regulations. This role focuses on continuous improvement, shop floor compliance and implementation of lean manufacturing initiatives aligned with department goals. NOTE: This position is 2nd shift Tuesday -Saturday (4p-12a) Position Description: <ul><li> Assists the managers in the direct processing of materials to ensure attainment of business results.</li><li> Develops an in-depth knowledge of the equipment and process.</li><li> Builds knowledge of the company, process, clients and/or customers </li><li> Applies Team effectiveness skills, listening and integrating diverse perspectives from across the workgroup.</li><li> Manage conflict and effect resolution of technical and personal challenges using standard procedures is key as is openness to change and the ability to effect positive change.</li><li> Contributes and adds value to the achievement of Team goals.</li><li> Tool development for shop floor execution and operability of manufacturing processes </li></ul> Under the direction of an Associate Director, the successful candidate will be responsible for: Compliance: <ul><li> Ensure compliance with safety and environmental practices, cGMPs and Standard Operating Procedures (SOPs) in the work area.</li><li> Demonstrate integrity, credibility, and flexibility in their daily performance so as to motivate others to do the same.</li></ul> Business Expertise: <ul><li> Perform a thorough review of batch records and related GMP documentation, identifying and resolving discrepancies in a timely manner and implementing corrective actions to improve the batch record execution/review process.</li><li> Work with Subject Matter Experts (SME's) to provide/track necessary training for operator qualification as assigned.</li><li> Participate in the design and implementation of training and development programs and training materials.</li><li> Foster a mutually beneficial relationship with manufacturing floor personnel focused on high quality investigations, meaningful corrective actions and reducing the deviation generation rate.</li><li> Establishes/implements appropriate and effective corrective and/or preventative actions (CAPAs) to prevent reoccurrence of deviations and ensure they improve the Right First Time metrics.</li></ul> Problem Solving: <ul><li> Identifies and solves a range of problems in straightforward situations; analyzes possible solutions and assesses each using standard procedures.</li></ul> Decision Making: <ul><li> Makes decisions that are guided by site policies and procedures.</li><li> Partners with supporting departments such as Quality, Tech Ops and Maintenance to solve problems in an efficient and compliant manner.</li><li> Consults with manager on more complex decisions and issues that impact other departments.</li></ul> Project Management: <ul><li> Accountable for contribution to project Team or sub-team, may manage/led a small project team.</li><li> Partners with Team members in the identification and implementation of continuous improvement initiatives and action plans </li><li> Supports activities in the areas of cost containment, efficiency, productivity, energy conservation, waste minimization, operational excellence, and lean practices.</li></ul> Resource Management: <ul><li> Aware of costs and assists in controlling costs related to own work.</li></ul> Minimum Required Education, Experience and Skills: <ul><li>Bachelor's degree or higher, preferably in Science, Engineering, Business Administration, or another technical field </li></ul> OR <ul><li>High School Diploma/GED with four (4) years of relevant experience in manufacturing or military service</li></ul> AND <ul><li>Willing and able to work off-shifts and weekends as needed</li></ul> Required Experience and Skills: <ul><li> Demonstrates strong leadership capability, problem-solving skills and a hands-on approach to problem solving. </li><li> Ability to work independently. </li><li> Willingness to work off-shift and weekends. </li></ul> Preferred Experience and Skills: <ul><li> People management background. </li><li> One to 2 years of cGMP experience in a sterile, bulk or finished pharmaceutical environment. </li><li> Manufacturing plant experience in operational capacity. </li><li> Union environment background. </li></ul>NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. VETJOBS MSJR Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 2nd - Evening Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 05/21/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/21/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R294095

Specialist, Operations 2nd Shift Weekend

Job Description Role Summary<ul><li>The US Associate Director Payer & Access Strategy Lead, Medical Affairs (US AD PASL) role supports the Global Medical and Scientific Affairs (GMSA) strategic priority Invest in the growth, success and well-being of our people" and prioritizes providing US Heath Systems/Healthcare Landscape experience, especially to ex-US GMSA employees.</li><li>The US AD PASL is responsible for regional Field Medical (FM) strategy, training, and prioritization of the Value & Implementation (V&I) plan for USMA Health Systems Oncology (HSO). The US AD PASL for health systems is an impactful member of US Medical Affairs (USMA) functional teams, US Regional Medical Affairs Teams (RMAT), US Value Teams (VT), and Field Leadership teams.</li><li>The US AD PASL drives US HSO strategic excellence and optimizes HSO Field Team readiness in support of clinical and pharmacoeconomic scientific exchange aligned to Global V&I plan priorities. This is a regionally based position (US) in our company's Research and Development (R&D) division.</li></ul>Responsibilities and Primary Activities<ul><li>Partners with US Health Systems Oncology executive leadership team to identify key areas of synergy to develop and deliver strategic communications in alignment with strategic priorities, objectives and business needs</li><li>Responsible for the direction, coordination, implementation, control, and execution of HSO strategy while remaining aligned to global medical and commercial strategy, commitments, and goals. Leads the US HSO integrated Field Medical (FM) plan process in collaboration with US HSO Executive Director (US HSO ED), US HSO Field Medical Alignment Director (FMAD), US HSO Team Leads, and Global Scientific Content - Health Systems (GSC-HS) content and training directors</li><li>Possesses relevant medical affairs and FM or clinical experience to guide and direct FM HSO strategy in alignment with organizational priorities and unmet needs</li><li>Collects, analyzes, and communicates scientific insights from US HSO Medical Affairs Director (MAD) field engagements to inform company strategies across our Research & Development Division /GMSA, Outcomes Research (OR), and Commercial; develops listening priorities and updates them quarterly.</li><li>Serves as US Health Systems Oncology interface between GMSA, Commercial, and other relevant headquarters (HQ) functions and the US HSO MAD field team</li><li>Identifies and prioritizes US HSO field resources, training needs, and activities, in collaboration with the GSC-HS directors, to optimize HSO MAD field team readiness</li><li>Collaborates with GMSA to define/implement strategic congress priorities for US HSO and coordinates planning of HSO MAD activities at key scientific congresses</li></ul>Required Qualifications, Skills, & Experience Minimum<ul><li>Advanced healthcare/science degree (MD, PhD, or PharmD)</li><li>Minimum of 2+ years of prior pharmaceutical industry experience, (preferably Field Medical experience or equivalent biotech/pharmaceutical/Medical Affairs strategy experience) OR equivalent</li><li>Demonstrated ability to create and implement a strategic roadmap</li><li>Excellent interpersonal, communication, networking, and results-oriented project management skills</li><li>Thorough knowledge of clinical medicine and medical affairs</li><li>Demonstrated ability to effectively work in a complex, matrixed environment (promoting inclusion, maintaining trust, and respecting others)</li><li>Ability to network and partner with important internal and external stakeholders, including cross functional teams, scientific leaders, and key decision makers</li><li>Knowledge of national and society treatment guidelines, clinical research processes, FDA regulations, and Office of the Inspector General (OIG), Health Insurance Portability and Accountability Act (HIPAA), and other ethical guidelines, laws, and regulations relevant to the pharmaceutical industry and its external stakeholder environment</li></ul>Preferred<ul><li>Prior experience leading complex projects with demonstrated ability to handle multiple projects and priorities simultaneously and function in a fast-paced environment</li><li>Formal training in pharmaco-economics/outcomes research</li></ul>NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $164,800.00 - $259,400.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 25% Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 06/8/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/08/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295647

US Associate Director Payer & Access Strategy, Medical Affairs, Oncology (Remote)

Job Description Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. Summary, Focus and Purpose The Senior Maintenance Technician | Vaccine Manufacturing Facility is responsible for providing equipment troubleshooting and maintenance support to VMF Operations areas (sterile supply, weigh/dispense, media, stabilizer/prep, thaw/pool, filling, capping/inspection, clean utilities etc.) located in aseptic and clean room environments. Work within a team to successfully complete maintenance and troubleshooting equipment and will conduct complex maintenance tasks, resolve deviations and evaluates equipment performance. Actively supports, participates, and embraces an empowered team culture including significant interaction with Production, Technical Operations, Quality and other support groups. This is a day shift position, 12 hour (6:00am - 6:00pm) rotation (2-2-3). The successful candidate for this position will work a hour 2, 2, 3 shift schedule (12 hours shift, 2 days on, 2 days off, 3 days on, 2 days off, 2 days on, 3 days off, repeats) which will include weekends and holidays. Key Functions<ul><li>Must have knowledge installing, repairing, and maintaining mechanical related equipment throughout a Manufacturing environment to include:<ul><li>Utility equipment (e.g. Clean steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, vapor compression stills, compressed gas systems</li><li>GMP production related equipment (e.g. Autoclaves, Fillers, Lyophilizers, Cappers and Automated Inspection Machines</li><li>The ability to satisfactorily perform all types of industrial mechanical work as assigned.</li></ul></li><li>Anticipates and solves complex production, maintenance, and operational problems, including off-shift and after hours support.</li><li>Strong sponsor for the problem solving efforts and solutions offered by other shifts and teams</li></ul>Additional Responsibilities: Must be flexible to perform all of the following functions and other tasks as needed:<ul><li>The ability to perform predictive maintenance and reliability tasks as assigned.</li><li>Outstanding communication skills helping to ensure that all shifts of assigned team are well informed and working at optimum efficiency</li><li>Identifies opportunities and implements projects that help improve the business by streamlining work</li><li>Maintains process equipment by developing/performing PM's, installing new equipment, documenting work using a computerized maintenance management system (SAP) and other duties as requested by the Coach or Mechanical Services Engineer.</li><li>Routinely provides technical guidance and maintenance/process training to others.</li><li>Responsible for participating in new equipment/replacement installations by interfacing with equipment vendors and recommending spare parts, selecting lubrication processes and assisting process project engineers.</li><li>Assists with execution of automation, validation and additional testing, as required</li><li>Follows instructions for completion of job tasks.</li><li>Completes written documentation of work performed.</li><li>Efficient and safe maintenance and repair of equipment using Hazardous Energy Control Procedures (HECPs)</li><li>Compliance with current good manufacturing procedures(cGMP), safety and environmental requirements/regulations/guidelines</li><li>The ability to follow complex instructions and use our business systems (SAP, ADP eTime, etc.)</li><li>Physical requirements - Must be able to lift 50 lbs, climb ladders and stairs, work on platforms and equipment above floor level.</li><li>Walking, bending, crawling, stooping is required.</li><li>Required to wear personal protective equipment including safety glasses, earplugs, gloves, hard hats, safety harnesses,etc.</li><li>Position requires aseptic gowning during performance of job duties</li><li>Must be willing to be vaccinated/blood tested for titer for products manufactured within the facility if needed</li><li>Required to support an on-call schedule to include days, nights and weekends on a rotational basis with other team members</li><li>Ability to manage multiple priorities and advance several tasks in parallel</li><li>Demonstrated mechanical aptitude</li><li>Proficient in the use of general hand and power tools, instruments and testing apparatus common to the electronic, mechanical, and instrumentation fields</li><li>Ability to read P&ID's, electrical drawings, blueprints, etc</li></ul>Education<ul><li>High School Diploma or GED required</li><li>Technical School Diploma or Associate Degree preferred</li></ul>Required<ul><li>A minimum of two (2) years of equipment maintenance or related experience</li><li>Computer fluency, including thorough knowledge of DeltaV</li></ul>Preferred<ul><li>Experience working in a clean room or GMP/regulated manufacturing environment.</li><li>Experience working on Clean Utility systems.</li></ul>NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement , all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. MSJR #VETJOBS #APAEBRG #NGNEBRG #ABRG #NAGIPEBRG #WNEBRG #LEADEBRG Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: Hazardous Material(s): Job Posting End Date: 05/25/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/25/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R294566

Senior Maintenance Technician | Vaccine Manufacturing Facility

Job Description Global Project and Alliance Management (GPAM) sits in the Research & Development Division (R&D). The Project Managers in GPAM are core members of cross-functional teams focused to deliver projects and products that improve human health and the business. Under GPAM, the CMC Integrated Project Management organization (CIPM) serves on the Development and Commercialization Teams (DCTs) responsible for developing and executing an asset's CMC (Chemistry Manufacturing & Controls) strategy. This is a growing organization that was formed within the past year and an exciting opportunity exists for a candidate who wants to play a key role in organization development and building a new team. Reporting to the Executive Director of CMC Integrated Project Management, the core responsibility of this individual will be to manage the Vaccines portfolio of products within CIPM. In addition, the Director will be expected to mentor/coach Project Managers (PMs) (through direct and indirect reporting relationships), including understanding their projects and developing their knowledge of drug/vaccine/biologics development, governance & team processes and PM skills. Primary Responsibilities: Portfolio and Project Management (50%)<ul><li>Responsible for aggregating individual program information to a portfolio view</li><li>Establish robust CMC and clinical stakeholder interfaces to maintain a pulse on all programs within the vaccines portfolio</li><li>Able to independently manage CMC development projects of any type, including those which require extensive experience with drug / vaccine / biologics development, and company processes/procedures related to commercialization and development teams</li><li>Support advancement of pipeline portfolio management including, but not limited to developing appropriate tools, dashboards, and business systems.</li><li>Manage cross divisional workstreams and lead or input into improvements to processes / templates that support product development or project management. </li></ul> Talent Development & Organization Advancement (50%)<ul><li>Coach staff in the nuances of managing a CMC project: management of team dynamics, understanding stages of development and how functional inputs interact to ensure project progression, coaching on Company processes associated with CMC development, strategic document preparation, PM skills, and effective team management. </li><li>Direct and develop a team of project managers, understand their projects and the developmental needs of the staff. The incumbent will be held accountable for ensuring performance of the staff is consistent with objectives and expectations, and for ensuring that if expectations are not being met, appropriate corrective measures are taken. </li><li>Accontable for ensuring that PM best practices are being employed across projects. </li><li>Actively participate in departmental administrative processes which relate to talent development/ management and improving the standards of the PM organization.</li><li>Serve as a change agent to promote adoption of business and departmental initiatives</li></ul> Education Minimum Requirements<ul><li>Bachelor's degree required; concentration in a scientific-related discipline preferred</li></ul>Required Experience and Skills:<ul><li>Six (6) + years in a PM related or leadership role</li><li>Demonstrated ability to manage resources, time, and budget effectively for given projects; is business savvy and results oriented </li><li>Experience with the planning and execution of strategies for drug / vaccine product registration and commercialization / life-cycle management (can be R&D, manufacturing or commercial perspective), with demonstrated ability to translate knowledge and expertise to other development teams and areas.</li></ul>Preferred Experience and Skills<ul><li>Advanced scientific degree (Master of Science (MS), Master of Business Administration (MBA), PharmD, Ph.D.)</li><li>Project Management Certification (PMP) or formal coursework/training in project management</li><li>Sufficient skill levels and technical understanding of CMC development to be recognized as a project management/CMC expert within the broader organization </li><li>Well-connected and networked within the company or has attributes that would allow establishment of such networks rapidly</li><li>Proven ability to analyze, integrate, recommend, contribute to development of conceptual plans for, and lead implement of, strategic, process, and team improvement and change initiatives cross-functionally</li><li>Effective at energizing others, establishing clear goals, delegating responsibility, mentoring and coaching within a team setting</li><li>Demonstrated situational leadership and creative problem solving within department and teams</li><li>Able to understand project details, but keep overall big picture" view of projects, priorities, and strategies </li><li>Strong communication skills, both oral and written. Knows when and how to speak up and appropriately raise issues to team and to management. Keeps both team members, departmental colleagues (as appropriate), and management fully apprised of project initiative status and issues at the right level of detail</li><li>Demonstrated courage of conviction - able to speak up / contribute in all circles; comfortable challenging ideas or proposals, including senior management.</li><li>Brings forward creative ideas and contributes to setting strategic plans for assigned projects.</li></ul>This position may be based in either Rahway, NJ, or Upper Gwynedd, PA. #GPAMjobs eligibleforERP #VetJobs #EBRG NOTICEFORINTERNALAPPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $164,800.00 - $259,400.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): NA Job Posting End Date: 05/31/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/31/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295724

Director, Vaccines Portfolio Lead- Hybrid

Job Description Scientist, Small Molecule Analytical Research & Development The Small Molecule Analytical Research and Development group has an opening for a Scientist based in Rahway, NJ. Join us and experience our culture first-hand - one of strong ethics & integrity, diversified experiences, exceptional science and a resounding passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. In your role as Scientist, you will be part of a team of Analytical Chemists working on cross-functional scientific teams to enable novel small molecule, peptide, and oligonucleotide drug development through laboratory-based analytical characterization and statistical data analysis . Primary Responsibilities <ul><li> Support execution of scientific studies to support development of active pharmaceutical ingredients (APIs), pharmaceutical formulations, and manufacturing processes using both traditional and advanced analytical tools. </li></ul><ul><li> Develop and implement analytical methods utilized during drug development as well as for the release and shelf-life assessment of clinical materials. </li></ul><ul><li> Troubleshoot challenges associated with drug development through active collaboration with cross-functional project teams </li></ul><ul><li> Document the execution, procedure, results, and conclusions of experiments in a detailed and organized manner. </li></ul><ul><li> Author internal memos, data summaries, and technical reports, and IND/ IMPD submissions to regulatory authorities. </li></ul><ul><li> Strong collaboration with fellow Analytical Research & Development colleagues as well as cross-functional partners. </li></ul><ul><li> Engage the external scientific community through membership in professional organizations, attendance at external conferences, and authorship of external publications. </li></ul> Education Minimum Requirements: Minimum 3 years relevant industry experience for applicants with a Bachelor of Science degree, or 0 years of relevant industry experience for applicants with a Master of Science degree in Chemistry, Pharmaceutical Sciences, or related fields. Required Experience and Skills Excellent written and oral communication skills, as well as strong collaboration skills , are required . Candidates will also be required to work in a team environment with cross-functional interactions. Preferred Experience and Skills Though not required , the ideal applicant would have hands-on experience in advanced chromatographic separation science, spectroscopy analysis, and other analytical laboratory and data analysis techniques . I n addition, experience with data science, dissolution, and mass spectrometry is advantageous . NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $83,100.00 - $130,900.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): Yes Job Posting End Date: 05/24/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/24/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R294908

Scientist, Small Molecule Analytical Research & Development

Job Description Position Description: With support of Sr CRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.<ul><li>Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.</li><li>Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. </li><li>Gains an in-depth understanding of the study protocol and related procedures.</li><li>Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.</li><li>Participates & provides inputs on site selection and validation activities.</li><li>Performs remote and on-site monitoring & oversight activities using various tools to ensure:</li><li>Data generated at site are complete, accurate and unbiased</li><li>Subjects' right, safety and well-being are protected</li><li>Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. </li><li>Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.</li><li>Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.</li><li>Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed. </li><li>Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites</li><li>Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.</li><li>Supports audit/inspection activities as needed.</li><li>Performs co-monitoring where appropriate.</li></ul>Extent of Travel <ul><li>Ability to travel domestically and internationally approximately 65%-75% of working time. </li><li>Expected travelling 2-3 days/week. </li><li>Current driver's license preferred.</li></ul>Qualifications, Skills & Experience Competency Expectations:<ul><li>Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support.</li><li>Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines. </li><li>Good understanding of Global, Country/Regional CRA Guidelines and ability to work within these guidelines. </li><li>Hands on knowledge of Good Documentation Practices </li><li>Developing skills in Site Management including management of site performance and patient recruitment</li><li>Developing level of monitoring skill and independent professional judgment.</li><li>Good IT skills (Use of MS office, use of some clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.</li><li>Works with high quality and compliance mindset.</li><li>Capable of managing complex issues, solution-oriented approach.</li><li>Ability to perform root cause analysis and implement preventative and corrective action.</li></ul>Behavioral Competency Expectations:<ul><li>Effective time management, organizational and interpersonal skills, conflict management</li><li>Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.</li><li>High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.</li><li>Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.</li><li>Demonstrates commitment to Customer focus.</li><li>Positive mindset, growth mindset, capable of working independently and being self-driven.</li><li>Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.</li></ul> Education Minimum Requirement: <ul><li>B.A./B.S. required with strong emphasis in science and/or biology. </li><li>Min. 2 years of clinical research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC or similar.</li></ul>MRLGCTO #EligibleforERP ETJOBS NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $75,400.00 - $118,700.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 50% Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: Yes Hazardous Material(s): NA Job Posting End Date: 05/24/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/24/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295706

Associate Clinical Research Associate - West Region (REMOTE)

Job Description Responsibilities As a Design Control and Risk Management Data Manager, you are a key member of the Device Development Team. Your will main responsibility is to develop and manage the data relationships through the development and life cycle of a product. Key responsibilities include the following: <ul><li> Partner with the Design Control and Risk Management leads to determine the data relationships and mapping. </li><li> Lead data review meetings with content owners and Quality. </li><li> Create and manage data linkages and relationships. Manage open deliverables and tasks. </li><li> Manage the Global Design File from concept, launch and post market. </li><li> Support second person review with source data for regulatory filing. </li><li> Support Design Transfer and Manufacturing readiness. </li><li> Manage data management approval workflows. </li><li> Support impact assessments for design changes during development and post market. </li><li> Utilize library data to drive cross project consistency. </li><li> Become the IT system SME and trainer. </li><li> Drive continuous process improvements. </li><li> Management updates to data and templates. </li></ul> Basic Qualifications <ul><li> Bachelor's degree in a Science, Technology, Engineering, or Math (STEM) field </li></ul><ul><li> 2-3 years in the medical device or pharmaceutical industry. </li></ul> Additional Skills & Preferences Demonstrated ability work multi-functional teams, work effectively across boundaries, and to effectively influence without authority <ul><li> Strong collaboration skills and ability to work productively in an interdisciplinary environment. </li><li> Integrated technical knowledge for IT system. </li><li> Excellent written and verbal communication skills, able to effectively interact at all levels of the organization - business leaders, senior technical/scientific personnel, internal/external customers/suppliers/ teammates </li><li> Strong project management skills. </li></ul>#EligibleForERP NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $83,100.00 - $130,900.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: Yes Hazardous Material(s): N/A Job Posting End Date: 05/24/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/24/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R294431

Scientist - Design Control and Device Risk Management (Hybrid)

Job Description With support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.<ul><li>Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.</li><li>Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.</li><li>Gains an in-depth understanding of the study protocol and related procedures.</li><li>Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.</li><li>Participates & provides inputs on site selection and validation activities.</li><li>Performs remote and on-site monitoring & oversight activities using various tools to ensure:</li><li>o Data generated at site are complete, accurate and unbiased</li><li>o Subjects' right, safety and well-being are protected</li><li>Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.</li><li>Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.</li><li>Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.</li><li>Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.</li><li>Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites</li><li>Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.</li><li>Supports audit/inspection activities as needed.</li><li>Performs co-monitoring where appropriate.</li></ul> Extent of Travel <ul><li>Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling 2-3 days/week.</li><li>Current driver's license preferred.</li></ul> Qualifications, Skills & Experience Competency Expectations: <ul><li>Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support.</li><li>Spanish speaking skills preferred.</li><li>Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.</li><li>Good understanding of Global, Country/Regional CRA Guidelines and ability to work within these guidelines.</li><li>Hands on knowledge of Good Documentation Practices</li><li>Developing skills in Site Management including management of site performance and patient recruitment</li><li>Developing level of monitoring skill and independent professional judgment.</li><li>Good IT skills (Use of MS office, use of some clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.</li><li>Works with high quality and compliance mindset.</li><li>Capable of managing complex issues, solution-oriented approach.</li><li>Ability to perform root cause analysis and implement preventative and corrective action.</li></ul> Behavioral Competency Expectations: <ul><li>Effective time management, organizational and interpersonal skills, conflict management</li><li>Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.</li><li>High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.</li><li>Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.</li><li>Demonstrates commitment to Customer focus.</li><li>Positive mindset, growth mindset, capable of working independently and being self-driven.</li><li>Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.</li></ul> Education Minimum Requirement: <ul><li>B.A./B.S. required with strong emphasis in science and/or biology. </li><li>Min. 2 years of clinical research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC or similar.</li></ul>MRLGCTO #EligibleforERP ETJOBS NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $75,400.00 - $118,700.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 50% Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: Yes Hazardous Material(s): NA Job Posting End Date: 05/24/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/24/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295719

Associate Clinical Research Associate - Florida (Remote)

Job Description With support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.<ul><li>Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.</li><li>Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.</li><li>Gains an in-depth understanding of the study protocol and related procedures.</li><li>Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.</li><li>Participates & provides inputs on site selection and validation activities.</li><li>Performs remote and on-site monitoring & oversight activities using various tools to ensure:</li><li>Data generated at site are complete, accurate and unbiased</li><li>Subjects' right, safety and well-being are protected</li><li>Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.</li><li>Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.</li><li>Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.</li><li>Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.</li><li>Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites</li><li>Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.</li><li>Supports audit/inspection activities as needed.</li><li>Performs co-monitoring where appropriate.</li></ul>Extent of Travel<ul><li>Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling 2-3 days/week.</li><li>Current driver's license preferred.</li></ul> Qualifications, Skills & Experience Education Minimum Requirement: <ul><li>B.A./B.S. required with strong emphasis in science and/or biology. </li><li>Min. 2 years of clinical research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC or similar.</li></ul> Competency Expectations: <ul><li>Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support.</li><li>Spanish speaking skills preferred.</li><li>Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.</li><li>Good understanding of Global, Country/Regional CRA Guidelines and ability to work within these guidelines.</li><li>Hands on knowledge of Good Documentation Practices</li><li>Developing skills in Site Management including management of site performance and patient recruitment</li><li>Developing level of monitoring skill and independent professional judgment.</li><li>Good IT skills (Use of MS office, use of some clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.</li><li>Works with high quality and compliance mindset.</li><li>Capable of managing complex issues, solution-oriented approach.</li><li>Ability to perform root cause analysis and implement preventative and corrective action.</li></ul> Behavioral Competency Expectations: <ul><li>Effective time management, organizational and interpersonal skills, conflict management</li><li>Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.</li><li>High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.</li><li>Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.</li><li>Demonstrates commitment to Customer focus.</li><li>Positive mindset, growth mindset, capable of working independently and being self-driven.</li><li>Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices</li></ul>MRLGCTO #EligibleforERP ETJOBS NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $75,400.00 - $118,700.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 50% Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: Yes Hazardous Material(s): NA Job Posting End Date: 05/24/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/24/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295713

Job Description Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry professionals ensuring the scientific value of our products is realized. We engage and train internal employees to ensure that they thoroughly comprehend the science behind the medicine and review further unmet medical needs to bolster collaboration and further differentiate our portfolio. Location: This is a remote position that serves Pennsylvania, Ohio, West Virginia, and Kentucky. Candidates MUST reside in the territory. Role Summary<ul><li>The Health Systems Oncology Medical Affairs Director (HSO MAD) is a therapeutic and disease expert who develops ongoing professional relationships with healthcare decision makers across key payer and provider organizations.</li><li>The HSO MAD provides accurate information across the full oncology product portfolio, clinical science, and quality management in a balanced and credible manner consistent with the regulatory environment and company's ethical standards. This role also serves as a resource for the Medical Affairs (MA) management team on strategic planning and provides mentoring for other team members.</li></ul>Responsibilities and Primary Activities<ul><li>Develops ongoing professional relationships with key decision makers in organized health systems to ensure access to medical and scientific information on the full oncology product portfolio and areas of therapeutic interest</li><li>Develops strategic account plans in partnership with the Integrated Account Management (IAM) Account Executive teams and executes medical activities in alignment with agreed plan</li><li>Serves as the primary resource for market dynamics within the territory to understand decision makers' evolving information needs to feed into the ongoing value-proposition development process for oncology product and non-product offerings</li><li>Effectively communicates and coordinates with Regional Medical Scientific Director (RMSD) regarding medical and scientific support needs in key health systems accounts</li><li>Serves as a resource for the HSO MAD Team Lead, HSO Executive Director Medical Affairs, and other members of Country Medical Affairs on other relevant strategic planning</li><li>Attends and supports scientific and medical meetings and prepares post-meeting deliverables</li></ul>Required Qualifications, Skills, & Experience Minimum<ul><li>MD, PhD, or PharmD </li><li>3 years of dedicated experience in a field-based MA role working with regional and/or national payers, integrated delivery systems, or scientific leaders OR 5 years of clinical oncology experience working within a health system OR the equivalent</li><li>Experience with organized healthcare system(s) or payer organization(s), including ability to develop peer-to-peer relationships with key decision makers</li><li>Thorough knowledge of clinical medicine, healthcare delivery system structure and function, pharmacoeconomics, disease management, quality management, value-based payment, and healthcare delivery policy and trends</li><li>Excellent interpersonal communication skills, ability to network, strong personal integrity, collaborative mindset, and a strong customer focus</li><li>Thorough understanding of ethical guidelines relevant to the pharmaceutical industry</li><li>Ability to organize, prioritize, and work effectively in a constantly changing environment</li><li>Demonstrable project leadership abilities</li></ul>Preferred<ul><li>Field-based medical experience working with regional and/or national payers, integrated delivery systems, or scientific leaders</li><li>Formal training in health economics and/or outcomes research</li></ul>NOTICEFORINTERNALAPPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $200,200.00 - $315,100.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 50% Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: Yes Hazardous Material(s): n/a Job Posting End Date: 06/8/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/08/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R294793

Health Systems Oncology Medical Affairs Director (PA, OH, KY, & WV) (Remote)

Job Description With support of Sr CRA/CRA Clinical Research Associate) and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.<ul><li>Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.</li><li>Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.</li><li>Gains an in-depth understanding of the study protocol and related procedures.</li><li>Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.</li><li>Participates & provides inputs on site selection and validation activities.</li><li>Performs remote and on-site monitoring & oversight activities using various tools to ensure:</li><li>Data generated at site are complete, accurate and unbiased</li><li>Subjects' right, safety and well-being are protected</li><li>Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.</li><li>Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.</li><li>Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.</li><li>Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM (Clinical Research Manager, TA Head and CRD (Clinical Research Director) as needed.</li><li>Works in partnership with GCTO (Global Clinical Trial Operations) country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites</li><li>Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.</li><li>Supports audit/inspection activities as needed.</li><li>Performs co-monitoring where appropriate.</li></ul>Extent of Travel<ul><li>Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling 2-3 days/week.</li><li>Current driver's license preferred.</li></ul>Qualifications, Skills & Experience Competency Expectations:<ul><li>Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information. Developing ability to present technical information with support.</li><li>Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.</li><li>Good understanding of Global, Country/Regional CRA Guidelines and ability to work within these guidelines.</li><li>Hands on knowledge of Good Documentation Practices</li><li>Developing skills in Site Management including management of site performance and patient recruitment</li><li>Developing level of monitoring skill and independent professional judgment.</li><li>Good IT skills (Use of MS office, use of some clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.</li><li>Works with high quality and compliance mindset.</li><li>Capable of managing complex issues, solution-oriented approach.</li><li>Ability to perform root cause analysis and implement preventative and corrective action.</li></ul>Behavioral Competency Expectations:<ul><li>Effective time management, organizational and interpersonal skills, conflict management</li><li>Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.</li><li>High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.</li><li>Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.</li><li>Demonstrates commitment to Customer focus.</li><li>Positive mindset, growth mindset, capable of working independently and being self-driven.</li><li>Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices</li><li>B.A./B.S. required with strong emphasis in science and/or biology.</li><li>Min. 2 years of clinical research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC (Clinical Trial Coordinator) or similar.</li></ul>MRLGCTO #EligibleforERP ETJOBS NOTICEFORINTERNALAPPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $75,400.00 - $118,700.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 50% Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: Yes Hazardous Material(s): NA Job Posting End Date: 05/24/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/24/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R296049

Associate Clinical Research Associate - Central Region (Remote)

Job Description The Animal Technician II, under the guidance of a Vivarium manager, works to support innovative translational models to impact drug safety assessment, development and discovery and improve human health. Under the direction of a manager or assigned technical staff within Laboratory Animal Resources, Nonclinical Drug Safety, and Veterinary Products the Animal/Laboratory Technician performs animal care related functions. Other duties include routine maintenance, animal handling and restraint, and assumes full responsibility and accountability for performance and documentation of all assigned functions for all the various animal species housed in accordance with the Animal Welfare Act, AAALAC- International, our Company Worldwide policy on Animal care and Use, and all federal state, and local regulations, as well as Standard Operating Procedures and If applicable, Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (cGMP). Receives, records, inventories, checks, and ships/ delivers animals, supplies, caging, and animal products, equipment, and materials within and outside the assigned group/ area. Candidate must have AALAS certification level ALAT or higher.<ul><li>Follows written assignments for husbandry in rodents, small and large animals, has proficiency in animal handling, experience in restraint for husbandry and clinical care. </li></ul> Husbandry activities will include but not be limited to <ul><li> Routine feeding, health assessment. </li><li>Cage change and room disinfection. </li><li>Accurate record keeping, captured manually and electronically. </li><li>Receipt, housing and identification.</li><li>Independently carries out duties related to husbandry, restraint for dose and sampling, laboratory housekeeping, organization of supplies, rack and tunnel washer operation.</li><li>Assists with training of peers, ensures completion and quality of daily assignment, and provides feedback on vivarium operations. </li><li>The ideal candidate will be comfortable working independently or in teams. </li><li>Must have the ability to follow Good Laboratory Practices (GLP) and or current Good Manufacturing Practices (cGMP)</li><li>Some areas require adherence to strict biosecurity measures, frequent showering and full gowning.</li><li>Performs duties related to the care, health, maintenance, security and safety of animals which may require full gowning and adherence to biosecurity practices. Ensures that physical facilities and equipment are operating correctly in order to maintain proper environmental conditions.</li><li>Maintains records applicable to animal husbandry procedures as assigned and assumes complete responsibility by certifying their completion through self-inspection.</li></ul>Educational Requirements:<ul><li>High School Diploma or equivalent</li><li>ALAT certification is required before placement.</li></ul> NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): NA Job Posting End Date: 05/31/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/31/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295684

Animal Care Technician Level 2

Job Description We are seeking a Growth and Improvement minded Senior Maintenance Technician | HVAC & Refrigeration that can help drive our Strategic Operating Priorities.<ul><li>Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs</li><li>Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)</li><li>Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape</li><li>Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world</li><li>Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success - They are a Competitive Advantage for Us</li></ul>Summary, Focus and Purpose The Senior Maintenance Technician | HVAC & Refrigeration is accountable for providing maintenance and troubleshooting supporting vaccine process equipment operations. Key Functions <ul><li>Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion</li><li>Take appropriate action to correct maintenance problems</li><li>Able to function in a team-based empowered culture | Seeks ideas and information on how to improve customer service involving internal and external customers</li><li>Applies knowledge of the overall supply chain to efficiently complete work tasks which is key in fulfilling the duties of collaborating in the creation of SOPs and preventative maintenance plans</li><li>Writing and maintaining accurate documentation of activities</li><li>Undertaking SAP transactions and change control activities including spare part lists and preventative maintenance plans</li><li>Actively supports, participates and embraces a team culture including significant interaction with operations, quality, automation, technology, and other groups</li><li>HVAC/R equipment (air handling units, building automation systems, -70 freezers and 2-8C cold rooms, refrigerators, heating hot water skids, incubators, etc.)</li><li>Support Systems (plant steam condensate systems in relation to air handling unit maintenance, operations, and reliability)</li><li>Automated systems (e.g., Distributed Control System, Programmable Logic Controllers)</li><li>Maintenance equipment (e.g., tools, calibration equipment, meters, and anemometers)</li><li>Installation, testing, adjustment, maintenance, repair, calibration and troubleshooting of complex automated process equipment</li><li>Interact with vendors other departments, contractors and disciplines on scheduling repairs, maintenance/projects, equipment testing, parts, troubleshooting and coordination activities like FAT, SAT, design reviews, and engineering assessments</li><li>Participates in the establishment and improvement of new and existing process equipment</li><li>Maintain utility equipment by developing/installing new equipment, completing validation protocols, documenting work using a computerized maintenance management system and other duties as requested by the Utility Maintenance Manager</li><li>Provides technical specifications and information to Quality, Manufacturing, Process-Project Engineers</li><li>Aids in the development of SOPs, engineering change requests, preventative maintenance plans/calibration procedures, task lists, etc.</li><li>Ensures appropriate spare part inventories are established and maintained</li><li>Actively participates in safety initiatives, including shop floor audits</li><li>Efficient and safe maintenance and repair of equipment using Lock-out Tag-out and Hazardous Energy Control Procedure updates</li><li>Completes in-depth troubleshooting and maintenance of equipment | Conducts preventative maintenance inspections and prepares inspection reports concerning the operation of equipment and mechanical condition of the equipment</li><li>Prepares technical documentation and preventative maintenance procedures when needed | Provides training to others | Completes written documentation of work completed</li><li>Executes SAP transactions including spare parts management and PM change control</li><li>Monitors calibration, maintenance, and equipment/utilities operations performance by analyzing completed work orders with an emphasis on reducing reactive work and increasing reliability</li><li>Aids in equipment and instrumentation related atypical investigations</li><li>Compliance with cGMP, safety and environmental requirements/regulations/guidelines</li><li>Ability to manage multiple priorities and advance several tasks in parallel</li><li>Proficient in the use of general hand and power tools, instruments, and testing apparatus commonly used in maintenance and instrumentation</li><li>Ability to read P&ID's, electrical drawings, blueprints, etc.</li></ul>Shift and Hours<ul><li> Rotating 12 Hour Shift (5-5-2) | 5-5-2 = Five Days On | Five Days Off | 2 Days On | 2 Days Off | 6:00 PM to 6:00 AM, 6:00AM to 6:00PM, transitioning nights to days every 3 months. Alternating Weekends and Holidays | Starts as 1st Shift Monday to Friday 7:00 AM - 3:30 PM until trained </li></ul> Education & Certification <ul><li>Required | High School Diploma/GED or higher and Universal Refrigerant Recovery Certification (EPA 608 Certification)</li><li>Preferred | Associate Degree in Industrial Systems, Mechanical, Electronics, Electrical or Instrumentation and Universal Refrigerant Recovery Certification (EPA 608 Certification)</li></ul> Required experience and skills: <ul><li>Two years HVAC/R experience with knowledge of technical craft skills (instrumentation, electrical, plumbing, advanced mechanical, and/or multi-stage refrigeration systems)</li><li>Working knowledge of regulatory requirements in accordance with GMP operations</li><li>BAS, HVAC/R and instrumentation troubleshooting skills</li><li>Able to read electrical prints, and control loops</li><li>Able to lift 50 pounds, climb ladders and stairs, work on platforms and equipment above floor level | Walking, bending, crawling and stooping</li><li>Proficiency in computer systems and applications including but not limited to: Microsoft Office (Word, Excel and Outlook), Programmable Logic Controllers, Calibration/Maintenance Database Systems</li><li>Strategic leadership skills with principled and positive verbal and written communication skills</li><li>Intelligent planning, scheduling, and time management skills</li></ul> Preferred experience and skills: <ul><li>Five years relevant HVAC/Refrigeration experience</li><li>Clean room or GMP regulated environment</li><li>Knowledge of industrial refrigeration systems which includes, cascade refrigeration systems, and absorption systems</li><li>Regulated industry such as FDA</li><li>Desiccant dehumidification system room pressure controls</li><li>Industrial experience involving utility system generation, distribution and control and strong knowledge of steam, compressed air, refrigeration and water systems</li><li>Installation, operation, maintenance and/or troubleshooting experience with automated process equipment in the biopharmaceutical field</li><li>GMP compliant calibration and/or maintenance database systems</li><li>Knowledge of SAP and Delta V</li></ul>NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. MSJR #EBRG VETJOBS TechhicianDurham Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 1st - Day, 3rd - Night Valid Driving License: No Hazardous Material(s): None Job Posting End Date: 05/31/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/31/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R294948

Senior Maintenance Technician | HVAC & Refrigeration

Job Description Our Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to identify and isolate a molecule that is effective against a disease target. Using innovative thinking, state-of-the-art facilities, and robust scientific methodology, we collaborate to discover and develop the next medical breakthrough. our Company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and Clinical Supply across all modalities. We are interdependent across our functional areas, Discovery, our Manufacturing Division Quality, and BARDS, to name a few, and with our partners in Finance, HR, IT, and Procurement. Together, we advance scientific and operational excellence at the interfaces of disciplines to translate breakthroughs into important new medicines and vaccines. This has a direct connection to our Company mission, and it will remain our True North. This acceleration will be supported by a foundation and a commitment to innovation and to our people. As a team, we commit to creating a culture of diversity and inclusion so everyone can bring their whole self to work. Within DSCS, the Digital Program Manager will advance the purpose and aspiration of our Company 's DSCS Digital Strategy to enable a seamless data infrastructure that drives increased speed, capacity and robustness across organizational deliverables. In this role, the DSCS Digital Program Manager will provide strategic and tactical direction and partner with the DSCS Digital Leadership Team to drive the Digital Strategy for our organization, comprising of Process Research & Development, Analytical Research & Development, and Pharmaceutical Sciences & Clinical Supply. The ideal candidate should have strong project management skills and a demonstrated commitment to operational excellence, with an established track record in solving complex problems. Experience in one or more of the areas of Drug Substance development, Drug Product development, Clinical Supply management or Analytical Research is critical for understanding business opportunities, outcomes and execution. The DSCS Digital Program Manager will: <ul><li>Work with the DSCS Digital Leadership Team, workstream leads and use case leads to define scope, build an integrated plan, track progress, risks, issues, mitigation plans and value realization. </li><li>Partner closely with IT and its Program Management to ensure alignment across planning and investment. </li><li>Set up, facilitate, and drive cross-functional meetings and workshops. </li><li>Map and monitor in-flight and planned projects in the adjacent digital landscapes that have the potential to impact DSCS Digital timelines and investments, and to inform what can be leveraged that is already in flight and identify gaps that need to be addressed. </li></ul>Knowledge, Duties & Responsibilities Include:<ul><li>Effectively manages and influences the DSCS Digital core team and extended team to ensure appropriately skilled and high-performing staff members are assigned to the program with the right time commitment, raising resource concerns in real-time with functional leadership. </li><li>Set clear performance standards and hold self and team members accountable for achieving results. </li><li>Develop business and technical content and compose complex presentations and both intra- and inter-divisional communications. </li><li>Optimize program execution inclusive of Scope, Quality, Timeline and Budget. </li><li>Partner with our Company IT leadership to develop a long-term systems and capability strategy and to prioritize DSCS Digital efforts. </li><li>Apply expert project and portfolio management skills effectively, with relatively broad managerial direction and minimal oversight. </li><li>Has a deep understanding of multi-modality composition of matter manufacturing, testing, quality and supply processes from late clinical development through commercialization and uses this understanding to drive value for the DSCS organization through its digital investments. </li></ul>Qualifications Education: <ul><li>Ph.D. with a minimum of 8 years relevant industry experience</li><li>B.S. or M.S. with a minimum of 10 years relevant industry experience</li><li>Concentration in a scientific-related discipline strongly preferred</li></ul>Required Experience and Skills: <ul><li>Research, manufacturing, and project/program management experience in pharma </li><li>Demonstrated ability to establish networks, build connections, and work across boundaries.</li><li>Proven ability to lead the planning and execution of cross-functional strategic change initiatives</li><li>Demonstrated ability to effectively manage scope, time, and cost of enterprise projects; is business savvy and results-oriented. </li><li>Effective at conveying a vision, energizing others, establishing goals, delegating responsibility, mentoring and coaching. </li><li>Well-developed and effective team facilitation and leadership skills; consistently establishes cooperative team environments. </li><li>Knows when and how to appropriately raise issues and drive discussion within peer groups and with senior management. </li><li>Demonstrated courage of conviction - able to speak up / contribute to all circles; comfortable challenging ideas or proposals, including senior management. </li><li>Brings forward creative ideas and contributes to setting strategic plans for assigned projects and departments. </li><li>Keeps relevant stakeholders fully apprised of project/initiative status and issues. </li></ul>Preferred Experience and Skills: <ul><li>Extensive experience with the planning and execution of strategies for drug / vaccine product registration and commercialization / life-cycle management (can be R&D and/or manufacturing) with demonstrated ability to translate knowledge and expertise to other teams and areas. </li><li>External engagement in project management / pharma-related networks/organizations. </li></ul>#EligibleforERP NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $164,800.00 - $259,400.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 06/3/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/03/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R293725

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