*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 Responsibilities: The key responsibilities of the Senior Specialist can be divided in the 3 elements: Site Production Planning<ul><li>In coordination with Sales representative, prioritize, sequence and communicate planned orders based on optimal resource allocation, availability, and constraint management.</li><li>Place production orders for production departments as required by forecast and align the production schedules with department to assure appropriate labor resources.</li><li>Monitor status of open production orders to ensure on-time delivery of all materials, including timely resolution, communication, and mitigation of future potential problems.</li><li>Partner with production and support areas to critically analyze and solve problems.</li><li>Planning and scheduling of pre-license serials, engineering batches, and field safety trial batches in production in coordination with cross functional groups.</li><li>Expedite or defer orders as required based on schedule/inventory changes.</li><li>Coordinate material flows throughout product/BOM changes, obsolescence, and/or materials due to new product development.</li><li>Setup & maintain material master system planning parameters.</li></ul>Supply Chain<ul><li>Manage, level load and report capacity utilization for months 1-12 as well as to interact with Global Supply Chain on the long-term Planning/ABR.</li><li>Participate in department, site planning, tier and operation meetings.</li><li>Determine and establish optimal inventory levels based on forecast, demand variation and material lead times.</li><li>Coordinate shipment and receipt of finished product and intermediary goods between regional sites.</li><li>Review and report on financial impact of site inventory destruction.</li><li>Leading BOM reviews.</li><li>Encourage supply chain knowledge transfer within the site.</li><li>On behalf of the Ames site participate in Launch, PIT, Transfer meetings as well as regional S&OP meetings.</li></ul>Part of the Site Leadership Team<ul><li>Manage one (1) direct report, who is responsible for buying and expediting raw material deliveries as well as planning international shipments in coordination with off-site international logistics teams.</li><li>Report on P&L and TTI metric tracking and support the Plant Manager & Finance with budget reviews.</li><li>Ensure and promote compliance to company and procurement policies and procedures.</li><li>Participate in weekly Site Leadership Team meetings and lead specific site hoshins/initiatives.</li><li>Work cross-functionally and collaboratively to apply Continuous Improvement methodologies to drive business efficiencies.</li></ul> Minimum required education: <ul><li>B.S./B.A. in Business, Supply Chain, Engineering or Science discipline</li></ul> Required experience and skills: <ul><li>Three (3)+ years of directly related experience in one or more of the following fields required: Supply Chain, Logistics, Buying, Material Procurement, or Manufacturing.</li><li>Experience working regulated industry.</li><li>Proficiency in SAP, Aera or ERP systems and Strong Microsoft Office Knowledge - especially Excel. </li><li>In addition, must be highly proficient in project management, multitasking and extremely detail-oriented and organized.</li><li> Principled and strong written and verbal communication skills. </li><li> Positive attitude, strong work ethic, ability to work under pressure, and be a fast learner. </li><li> Self-motivated individual with ability to work autonomously and with a high degree of accuracy. </li><li> Work in a Team- environment and collaborate cross-functionally. </li></ul> Preferred Skills: <ul><li> Financial acumen with risk-based decision making. </li><li> MPS skills pertaining to tier process, 8 step problem solving, standard work. management, A3 development and project management. </li><li>Good communication and follow-up skills with a strong customer service attitude.</li><li>Ability to self-direct and take constructive action in ambiguous situations.</li><li>Able to influence others & manage conflict.</li><li>Extremely high standards of excellence.</li><li>Analytical with a methodical approach to problem solving.</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: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Requisition ID:R292068

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Senior Specialist, Planner & Supply Chain

Job Description Position Description: The Operations Technician position is available at our Animal Health facility in Elkhorn, Nebraska, located on the West end of Omaha. The Elkhorn facility is expanding operations to manufacture animal vaccines and biologics. Looking for talented individuals to join our Production teams using key technologies for cell culture, blending, filling and packaging. The Operations Technician is accountable for critical laboratory procedures and duties in the production of veterinary products. Technicians work with a variety of technical equipment while completing duties involved in blending, filling vials or packaging finished products for distribution. At all times technicians must follow Good Manufacturing Practices and Standard Operating Procedures (SOP) and adhere to all safety and company policies while performing assigned duties. Some of the duties may include, but are not limited to:<ul><li>Comprehend and follow Standard Operating Procedures (SOP) and Outlines of Production. </li><li>Comprehend and comply with cGMP guidelines and complete and review documentation for accuracy and completeness.</li><li>Prepare media and perform necessary cleaning/disinfecting of equipment and laboratories. </li><li>Work in a clean, aseptic environment (clean room environment). </li><li>Operate lab equipment including pumps, centrifuges, roller racks and miscellaneous instruments.</li><li>Clean, wrap, and sterilize laboratory equipment.</li><li>Assist in antigen processing or serial batching equipment set up, sterilization, and operation.</li><li>Perform aseptic procedures during antigen processing or serial batching operations.</li><li>Operate automated packaging line, fill machines, capping machines, freeze dryers, autoclaves, dry heat ovens, etc. in accordance with standard operating procedures.</li><li>Maintain concurrent records including manufacturing directions, log sheets, and all other pertinent documents.</li><li>Assist in monitoring and requisitioning laboratory supplies.</li></ul> Hours for the position are Monday - Thursday 5AM - 3:30PM. Education Minimum Requirement: <ul><li>High School diploma or equivalent; College degree in a relevant scientific field (biology / chemistry, life science) preferred.</li></ul> Required Experience and Skills: <ul><li>Strong verbal and written communication skills</li><li>Basic Math aptitude</li><li>Strong work ethic</li><li>Ability to lift 50lbs on an intermittent basis</li><li>Attention to detail</li><li>Ability to follow approved documentation practices</li><li>1-2 years relevant experience working in a production laboratory</li><li>Ability to work in a team environment</li><li>Basic computer skills (Word/Outlook/Excel)</li><li>Ability to follow Good Manufacturing Practices and Standard Operating Procedures</li></ul> Preferred Experience and Skills: <ul><li>2-3 years relevant manufacturing experience and a basic understanding of manufacturing procedures, techniques and equipment</li><li>Working knowledge of current cGMP and inventory control concepts (strongly preferred).</li><li>Knowledge of aseptic techniques and procedures.</li><li>Experience in large scale bacterial antigen processing and serial batching.</li><li>Experience using SAP&reg;</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. Residents of Colorado Click here to request this role's pay range. 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): n/a Requisition ID:R291432

Technician, Operations

Job Description We are currently recruiting for a Director of Global Oncology Marketing to join a dynamic area of the business supporting the Disease Area Strategies for Melanoma. Reporting to the Global Disease Lead for Skin Cancers, The Director of Global Oncology Marketing - Melanoma provides the opportunity to lead our early-stage disease area, playing a critical role in product and portfolio development, maximizing in-line performance to support patients, and leading the competitive strategy. Successful candidates will ideally possess strong scientific knowledge of melanoma, as well as a solutions- and results-oriented mindset, exceptional collaboration abilities, and effective communication skills. Key responsibilities include and may not be limited to the following: <ul><li>Work effectively with cross-functional partners including research and development, medical affairs, regulatory affairs, manufacturing, business development & licensing, market analytics, international and domestic operations, legal, scientific communications, professional education, training and development, health care compliance to successfully navigate the internal and external environments and deliver value to our customers</li><li>Lead cross-functional team in the development of a comprehensive global competitive strategy</li><li>Collaborate with asset teams to inform new product launches in melanoma</li><li>Provide commercial leadership and input in key opinion leader engagement execution, target product profile development, health authority interactions, global regulatory filing strategy, organized customer interactions, and market research</li><li>Support forecasts for new study recommendations and/or business development activities</li><li>Develop Global Guidance for market forecasts for in-line indications</li><li>Collaborate with Regions and Markets, Market Access, CORE, Medical Affairs, and Asset teams on the strategy, planning and execution</li><li>Maximize physician acceptance, market penetration, profitability, and product launch uptake</li><li>Provide commercial perspective to mature brands planning</li></ul> Qualifications: Minimum Requirements:<ul><li>Bachelor's Degree</li><li>Minimum 6 years of experience, which can be a combination of marketing, sales, market access & pricing, marketing support or related functions within the pharmaceutical or biotechnology industries</li><li>Understanding of Oncology healthcare market dynamics around innovation & capabilities, and the science of Oncology</li><li>Understanding of healthcare trends and reimbursement and policy issues and their potential impact upon our Company's business opportunities</li><li>Experience leading strategy development and implementation</li><li>Strong business acumen and ability to drive initiatives forward</li><li>Strong collaboration skills, both within commercial teams and cross divisional teams</li><li>Ability to clearly articulate messages/information across the enterprise and to leadership</li><li>Ability to work within complex organizations and markets and leading sub-teams and influencing without authority.</li><li>Ability to lead and inspire direct report(s) to ensure high individual and team performance and personal development</li><li>Able to work hybrid and come into the office at least 3 days per week</li></ul> Preferred Education, Experience, and Skills: <ul><li>Advanced Degree (i.e. MBA)</li><li>Global Marketing experience</li><li>Strong scientific knowledge and experience in Oncology, ideally Melanoma</li><li>Forecasting and strategy development experience.</li><li>Experience providing commercial input on such activities as:<ul><li>target product profile (TPP) development, global regulatory filing strategy, launch readiness reviews, organized customer interactions, market research, demand, revenue, and P&L forecasting, BD&L activities, product development team (PDT) and agency partner management</li></ul></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: $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: 25% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: Yes Hazardous Material(s): n/a Requisition ID:R291756

Director, Global Oncology Marketing - Melanoma (Hybrid)

Job Description Our Animal Health Research & Development team work tirelessly to invent solutions to improve the health and wellbeing of animals. Our state-of-the-art research facilities create an environment of innovation that enable us to create breakthrough science changing the way we approach animal health challenges. Senior Scientist Position for Companion Animal R&D Group Job Description:<ul><li>Responsible for designing, planning, and executing experiments and animal studies for the development of new or improved veterinary or biological products.</li><li>Independently perform complex laboratory and animal work including laboratory-scale bioreactors and fermenters.</li><li>Serve as study director or principal investigator to develop and manage project plans and timelines; be accountable for the timely preparation of progress reports and presentations according to agreed plans and milestones.</li><li>Efficiently manage and leverage the resources within the team and department to ensure on-time delivery of project timelines and milestones. Closely collaborate with other cross-functional teams and internal stakeholders.</li><li>Function as the subject matter expert in the responsible area and provide support, coaching, training, or assistance to other team members.</li><li>Independently write laboratory procedures, study protocols, and study reports.</li></ul>Education:<ul><li>Bachelor's degree in biology, microbiology, virology, immunology, or related area of study with at least 5 years experience in the animal health industry.....OR, a PhD in biology, microbiology, virology, immunology, or related area of study.</li></ul>Required Experience and Skills:<ul><li>Demonstrated experience in cell culture/aseptic technique, virus and/or bacterial propagation, and extensive knowledge of laboratory techniques such as ELISA, virus titration, bacterial enumeration, serum neutralization assays, and PCR.</li><li>Demonstrated ability to troubleshoot laboratory equipment and study/experiment results.</li><li>Demonstrated experience with laboratory-scale bioreactors and/or fermenters.</li><li>Strong verbal and written communication skills and very strong time management and organization skills.</li><li>Experience with working with animals in a laboratory setting, especially cats and dogs.</li><li>Computer skills such as Microsoft Office and Outlook.</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: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: Yes Hazardous Material(s): N/A Requisition ID:R292072

Senior Scientist, Research & Development - Animal Health

Job Description Our Animal Health team offers veterinarians, farmers, pet owners and governments one of the widest range of veterinary pharmaceuticals, vaccines and health management solutions and services. The Millsboro, DE Animal Health facility is located in Sussex County, DE, within the Salisbury, MD-DE Metropolitan Area. Millsboro is situated at the first point on the Indian River and is conveniently located 20 minutes from the beautiful Delaware beaches and 40 minutes from Ocean City, MD. Millsboro is rich in culture and is home to the Nanticoke Indian Tribe. Free concerts in the park, the outdoor farmer's markets, dining at the many restaurants, antique and vintage shopping and boating are just some of the many ways people enjoy life in this quaint river town. We are looking for talented individuals to join our Production teams using key technologies for cell culture, filling and packaging. Join us and experience our culture first-hand - one of strong ethics and integrity, diversified experiences, and a passion for improving animal health. Our company, consistently cited as a great place to work, discovers, develops, manufactures, and markets a wide range of vaccines and medicines to address unmet medical needs. We are hiring Technicians within multiple products and processes including but not limited to: Sterile Services, Viral Bulk Manufacturing, Blend/Fill, Packaging, and Warehousing. The hiring team will evaluate your skills to determine where you can make the greatest positive impact as a Technician. Whether you have a diploma, degree, or in between, we will likely have something that fits you. What you can expect: Starting on day one, we will provide you the necessary training the Technician will need to follow Good Manufacturing Practices and Standard Operating Procedures and adhere to all safety and company policies while performing advanced laboratory services in various manufacturing areas. Throughout your career, we will offer you continued development through training classes, workshops, meetings, etc., to improve job skills and product-related procedures. Some duties may include but are not limited to the following:<ul><li>Work with a variety of manufacturing equipment while completing processes throughout the manufacturing cycle</li><li>Assist with equipment setup and operation.</li><li>Performs manual and/or automated operations, general maintenance and support functions</li><li>Housekeeping in all work areas | Executes facility decontamination according to approved procedures</li><li>Assist with performing aseptic procedures including media preparation, antigen inoculation and harvest, tissue culture preparation and harvest, filling vaccines, etc.</li><li>Assist with performing non-aseptic procedures including handling of live poultry in the process of harvesting tissue and waste.</li><li>Filling, labeling, capping, packaging, and inspecting product.</li><li>Concurrent record keeping including charts, log books, and all pertinent documentation.</li><li>Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while notifying appropriate personnel</li><li>May be accountable for accumulation, labeling and management of hazardous wastes, as appropriate to their area, providing you are properly trained prior to assignment.</li><li>Demonstrates, at all times, safe work habits and maintains a safe work environment. Comprehends and complies with all safety and company policies and procedures.</li><li>Assist in weekly reports as assigned.</li><li>Attend training classes, workshops, meetings, etc., as required to improve job skills and product-related procedures.</li></ul>Required Education:<ul><li>High School diploma/GED</li></ul>Required Experience:<ul><li>Ability to operate manufacturing equipment with training </li><li>Strong attention to detail and documentation skills are required</li><li>General knowledge of reading, mathematics and computer skills are required.</li><li>Ability to communicate and work in cooperation with other employees in a manufacturing environment.</li><li>Successful completion of a Physical Abilities Test.</li></ul>Working conditions:<ul><li>This position may have varying hours based on the needs of the business</li><li>May require a rotating shift</li><li>Flexibility working overtime is a requirement in manufacturing</li><li>Travel is not a part of this position</li></ul>MSJR 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: Shift: 1st - Day, 2nd - Evening Valid Driving License: No Hazardous Material(s): N/A Requisition ID:R277830

Operations Technician

Job Description The mission of Quality Assurance is to: safeguard the rights and well-being of patients; the welfare of animals; comply with applicable global regulatory requirements through sound processes and procedures, and to provide independent assurance that delivers high quality data and clinical supplies. This position reports to the Associate Director, Global Clinical Supplies Quality and is critical to maintaining the global clinical supply chain via disposition activities for clinical finished goods provided by our Company for worldwide clinical trials. Specifically, this includes batch documentation review ensuring our clinical supplies are in compliance with current Good Manufacturing Practices (cGMPs) regulations and relevant regulatory filing submissions. Areas of focus of this position revolve around the detailed workings of clinical packaging, labeling and distribution activities and associated regulatory submissions for Investigational New Drug applications and Clinical Trial Applications in relation to complex/niche supply chains and supply types for clinical protocols as well as Managed Access Programs, Joint Ventures/Collaborations, Independent Investigator-Initiated Studies, etc. Responsibilities may include, but are not limited to: <ul><li>Evaluation and disposition of clinical supply materials with the assurance that the materials were produced in conformance to all applicable policies/procedures of our Company and compliance with all governing regulations. </li><li>Coordinate and/or support the preparation of procedures, processes and quality improvements. </li><li>Assists in the coordination of significant quality events including fact finding, investigation, coordination of clinical quarantine and recovery actions. </li><li>Collaboration across cross-functional and business areas to ensure robust processing, continuous improvement and cross-functional team building.</li><li>Providing on-the-floor coaching/guidance of operational and technical issues; providing immediate resolution on the shop floor to deviations and potential deviations.</li><li>Completing projects to improve the performance of our processes, including continuous process improvements, investigation Corrective/Preventative Actions (CAPAs), and value capture projects that seek to improve outcomes, reduce cost, or lower our processing cycle times.</li><li>Managing investigation, change request and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible.</li><li>Actively using and championing the use of Lean Six Sigma (LSS) and our Company's Production System (PS) tools, both in problem-solving and day-to-day operational activities. </li></ul>Education: <ul><li>Bachelor's degree with a technical emphasis in an appropriate scientific or engineering field.</li></ul>Required Experience and Skills: <ul><li>Minimum of 5 years experience in the pharmaceutical or equivalent industry Good Manufacturing Practice (GMP) related field including Technical, Engineering, Quality or Operations.</li><li>Familiarity with batch disposition (release) activities.</li><li>Prior experience reviewing and approving investigations, deviation management support, and Corrective/Preventative Actions (CAPAs).</li><li>Background in quality control, quality assurance, auditing or regulatory affairs. </li><li>Effectiveness and creativity in approaching and solving technical problems.</li><li>In-depth working knowledge of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area. </li><li>Basic understanding of the use and maintenance for Microsoft applications (such as Excel, Outlook, Access).</li><li>Evidence of leadership skills coupled with highly developed oral and written communication skills, i.e., effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills. </li><li>Demonstrated teamwork skills.</li><li>Attention to detail, flexibility and an awareness of production and quality control problems.</li></ul>Preferred Skills:<ul><li>Ability to independently manage multiple priorities and projects.</li><li>Ability to lead and support teams of a cross-functional and multi-level nature, including senior management representatives. </li><li>Demonstrated analytical and problem-solving skills.</li><li>Knowledge of Lean Six Sigma and Project Management.</li><li>Knowledge and competency in ERP/MES, Trackwise, SAP, PowerPoint, Excel and Word.</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: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: Yes Hazardous Material(s): N/A Requisition ID:R277271

Senior Specialist, Clinical Supplies Quality (Hybrid)

Job Description The Small Molecule Analytical Research and Development (SMAR&D) group has an exciting opportunity for a Principal 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 this role as a Principal Scientist, you will be part of a team develop-ing innovative analytical methodologies for early to late phase pro-grams with application to drug substance and a broad array of drug product dosage forms, combination products and modalities through analytical characterization, imaging tools, and data analy-sis. You would also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities include: <ul><li> Driving solutions to analytical development challenges for small molecules, peptides, mRNA, oligonucleotides, and bioconjugates using conventional and novel technologies through active collaboration with cross functional project teams and external vendors. </li><li> Designing scientific studies to inform the selection and deep understanding of synthetic routes, to inform the selection of early development and market formulation compositions and manufacturing processes, documented in a detailed and timely manner. </li><li> Develop and implement analytical methods utilized for both development as well as methods for the re-lease and shelf-life assessment of clinical supplies under good manufacturing practice (GMP) settings. </li><li> Providing analytical leadership not only on drug development pipeline projects, but also innovative technology teams shaping analytical methods and tools of the future. </li><li> Author investigational new drug (IND), investigational medicinal product dossier (IMPD), and new drug application (NDA)/ worldwide marketing application (WMA) submission documents across the project development lifecycle, as well as responding to agency questions. </li><li> Strong collaboration with internal stakeholders and external partners. </li><li> Presenting results of experiments and innovation efforts to project teams and at various cross-functional forums. </li><li> Scientific supervision and day-to-day oversight of junior analytical scientists. </li><li> Present results of experiments and innovation efforts to teams and internal governance bodies. </li><li> Partnering with managers to shape development strategies </li><li> Be a leader within the external scientific community in professional organizations, conferences, and publica-tions as well as analytical technology and regulatory sciences related focus groups and consortia. </li></ul> Qualifications Education Minimum Requirements Applicants must hold one of: <ul><li> PhD Degree in Analytical/Biochemistry/Pharmaceutical Sciences or related fields with at least 7 years of pharmaceutical industry experience. </li><li> Master's Degree in in Analytical/Biochemistry/Pharmaceutical Sciences or related fields with at least 10 years of pharmaceutical industry experience. </li><li> Bachelor's Degree in in Analytical/Biochemistry/Pharmaceutical Sciences or related fields with at least 12 years of pharmaceutical industry experience. </li></ul> Required Experience and Skills A strong team player with excellent written and oral communication skills, as well as strong leadership and interpersonal skills are necessary to qualify for this role. Additional skills: <ul><li> Strong background in analytical control strategy development and execution </li><li> Demonstrated ability to develop talent through good mentoring skills </li><li> Demonstrated ability for taking initiative, creativity, and innovation in problem solving </li><li> Ability to design, execute and/or direct the development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development </li><li> A proven record of strong technical problem solving and innovative research experience, supported by scientific publications. </li><li> Ability to work both independently for development of analytical methodologies and cross-functionally for successful transfer methods. Plan optimization and documentation to meet program deadlines. </li><li> Authoring and reviewing internal technical reports, sections of regulatory filings (e.g., IND, BLA) and external scientific publications. </li><li> Experience with matrix management and peer to peer coaching </li><li> Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment. </li></ul> Preferred Experience and Skills While not required, experience in one or more of the following areas is preferred: <ul><li> Hands-on chromatography (e.g., LC, GC) method development, analysis and troubleshooting. </li><li> Other advanced analytical techniques such as mass spectrometry or dissolution. </li><li> Experience in development and characterization of small and/or large molecules, mRNA, and/or antibody drug conjugates </li><li> Established scientific reputation supported by publications and external presentations </li><li> Experience in high-throughput experimentation and data-rich experimentation, or data science </li></ul> #EligibleforERP #AR&D 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: $149,400.00 - $235,100.00 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: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Requisition ID:R291752

Principal Scientist, Small Molecule Analytical Research & Development

Job Description Job Description<ul><li>The Director, Team Lead, Global Medical Information (GMI), is a member of the GMI Leadership Team and reports directly into the Senior Director, GMI Oncology. The role is headquarters-based within Global Medical and Scientific Affairs (GMSA) and is responsible for providing strategic and tactical leadership and direction to a group of professionals with advanced educational backgrounds and therapeutic area expertise.</li><li>With a high degree of medical/product knowledge and communication, management, and collaboration skills, combined with emotional intelligence, the GMI Team Lead for Oncology independently manages resources and workload of a Team across the global core functions of the GMI group: Medical Information (MI), Medical/Scientific Review of promotional materials and scientific content, Compendia and Pathways submissions, and MI Training of internal stakeholders.</li></ul>Primary Responsibilities<ul><li>Leads respective therapeutic area (TA) team and partners with GMSA colleagues and our company's Research Laboratories cross-functional teams and stakeholders (e.g., Publications, Scientific Affairs, Medical Directors, Regional Medical Scientific Directors, Compliance, Center of Observational and Real-World Evidence [CORE]) worldwide to implement strategic initiatives for the assigned franchises. Facilitates execution of defined franchise strategies through leadership and management of direct reports, ensuring alignment of their objectives with those defined by the franchises, and ensuring that US-specific Medical Information content, US/Global promotional materials and scientific content, Compendia and Pathways submissions, and MI training initiatives are aligned with the corresponding plans of these stakeholders.</li><li>Resolves escalations of complex issues/challenges by providing strategic guidance and solutions to GMI Team, based on experience, process, TA, and subject matter expertise. Ensures that the team objectives are achieved for core functions.</li><li>Represents their GMI Team by providing generated internal/external insights to the Global Scientific Content (GSC) Team, and ensures appropriate use of the scientific content by their GMI Team for responding to US and escalated complex global Medical Information Requests (MIRs).</li><li>Drives the GMI Team's approach to scientific/medical review of US/Global promotional materials and scientific content and provides guidance on the strategic planning for Compendia and Pathways submissions.</li><li>Conducts audits across content to ensure consistency in approach and to ensure team compliance to the policies, standard operating procedures (SOPs), and regulations governing the GMI core capabilities.</li><li>Leads generation of quantitative and qualitative analyses and insights and sends respective reports to designated stakeholders.</li><li>Partners with GMI Senior Management to develop and lead departmental initiatives which impact GMI process and SOP improvements, and fosters innovation and cross-functional collaborations.</li><li>Sponsors change and inspires team to drive change and innovate.</li><li>Responsible for Human Resources (HR) activities of the GMI Team, including:<ul><li>Recruiting and hiring</li><li>Talent review and performance feedback and evaluation for direct reports</li><li>Ongoing coaching/mentoring and skill and career development</li><li>Addressing HR and personnel issues</li></ul></li></ul>Minimum Education/Experience Requirements<ul><li>Doctoral degree (PhD, PharmD, MD or equivalent) + 6 years total combined Medical Information, Medical Review, and people/project management experience</li><li>MS degree + 8 years total combined Medical Information, Medical Review, and people/project management experience</li></ul>Required Experience and Skills<ul><li>Relevant and current experience working within Medical Information and Medical Review capabilities in the pharmaceutical industry and must have acted as a role model with advanced Medical Information and Medical Review expertise and competencies</li><li>Proven track record of leadership on Medical Information/Medical Review initiatives/projects, with resulting impactful process and/or system improvements</li><li>Mentoring, coaching, talent-building/team development skills in Medical Information/Medical Review</li><li>Ability to work in a complex organizational environment and effectively operate in a team-oriented global structure</li><li>Excellent interpersonal and communication skills (written and oral), as well as the ability to proactively speak up and represent GMI at cross-functional meetings/workstreams/initiatives</li><li>Proven networking, prioritizing, and cross-functional leadership and management skills and must be proactive and results-driven with demonstrated initiative and established solutions-oriented ways of working</li><li>Therapeutic competency in Oncology</li></ul>Preferred Experience and Skills<ul><li>Direct report management experience (full-time employees or contractors) preferred</li><li>Proven influence, collaboration, and negotiation skills for interaction with cross-functional teams</li><li>Solid understanding of other GMSA stakeholder functions and how GMI successfully partners across GMSA as well as other Company divisions</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: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Requisition ID:R291332

Director, Global Medical Information Team Lead - Oncology

Job Description The Department of Biostatistics and Research Decision Sciences (BARDS) is a key functional group in our company's Research Laboratories. Since its establishment in 1938, this department has provided 85+ years of quantitative leadership in the innovation and application of research design and statistical analysis methods fundamental to effective pharmaceutical R&D. The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment, transparent communication, and effective management of product risk profiles across our Research and Development Division pre- and post-marketing development stages. Key responsibilities for the position:<ul><li>Serve as a statistical representative and core member in the Risk Management Safety Teams. Lead and provide statistical support for related drug/vaccine projects in Clinical Safety Statistics</li><li>Interact with Safety Physicians, Safety Scientists, Clinical Trial Physicians , Regulatory, Early/Late Development Statistics, Statistical Programming, , and other company Research Laboratories Scientists in the planning and execution of ongoing safety evaluation across pre-marketing and post-marketing development stages</li><li>Design, develop and evaluate processes and tools for product safety evaluation, including ongoing aggregate safety evaluation</li></ul> Primary activities for the position :<ul><li>Lead and provide statistical support to the cross-functional safety teams for the strategic planning and scientific reasoning that facilitates safety and benefit-risk evaluations</li><li>Plan and execute on aggregate safety evaluations, including cumulative meta-analysis of safety, as applicable. Coordinate and ensure that all deliverables meet analysis requirements, standard operating procedures, and regulatory requirements</li><li>Design, develop and apply safety evaluation methods (including visual analytics), processes, standards and tools</li><li>Collaborate with the Late Development Statistics (LDS) and Statistical Programming (SP) to strategize and plan high quality integrated safety analyses for NDA submission and periodic risk-benefit evaluation</li><li>Interact with regulatory agencies worldwide to engage on statistical issues associated with the ongoing aggregate review of safety. </li><li>Prepare oral or written reports to effectively communicate results of safety evaluations to the project teams</li><li>Mentor and guide junior staff in functional activities.</li></ul>Skills Education and Minimum Requirement: <ul><li>PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 3 years relevant work experience, or Masters with a minimum of 6 years relevant work experience.</li></ul> Required Skills and Experience :<ul><li>Solid knowledge of statistical analysis methodologies and experimental design, particularly in meta-analysis and bayesian methodologies.</li><li>Solid knowledge of statistical and data processing software e.g. SAS and/or R. </li><li>Good project management skills. </li><li>Good understanding of worldwide regulatory requirements and clinical trial expertise .</li><li>Strong oral and written communication skills. Able to function effectively in a team environment. </li><li> Demonstrate strong interest in statistical research activities and in application of novel methods for clinical safety evaluation </li><li>Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.</li></ul> Preferred Skills and Experience :<ul><li>Publications in peer reviewed statistical/medical journals. </li><li>An understanding of biology of disease and drug discovery and development.</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. BARDS2020 #eligibleforERP #DATA2020 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: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Requisition ID:R285961

Associate Principal Biostatistician, Clinical Safety Statistics (CSS), Hybrid

Job Description The Senior Statistical Programmer, Study Data Tabulation Model (SDTM), provides oversight and creation of the SDTM deliverables for analysis and reporting and world-wide regulatory application submissions of drug and vaccine clinical development projects. Accountability predominantly includes creation and validation of Case Report Tabulation study data deliverables using Extensible Markup Language (XML), Study Data Reviewer Guide (SDRG), Annotated Case Report Form (aCRF)), collaborating and consulting with project teams, outreach to external vendors and partners, and keeping current with industry submission data standards. The incumbent will be responsible for continuous improvement of our electronic submission process for study data standard deliverables and providing tools and templates to support delivery focusing on traceability, quality assurance, data conformance and data fitness. The position is a key collaborator with internal and external stakeholders including Statistical Programming, Statistics, Regulatory, Data Management, Clinical and other project stakeholders. Primary Responsibilities<ul><li>Supporting project teams in creating (SDTM) Study Data Tabulation Model deliverables for Analysis and Reporting (A&R) and submission</li><li>Supporting project teams in preparing submission deliverables including use of Pinnacle 21 Enterprise</li><li>Up-versioning activities to specific versions of Study Data Tabulation Model (SDTM)</li><li>Develop Statistical Analysis System (SAS) programs, standards macros to enhance the process.</li><li>Collaborate effectively with project team members.</li><li>Participation in industry teams and conferences on best practices</li><li>Membership on departmental strategic initiative project teams</li></ul> Education Minimum Requirements: <ul><li>Bachelor of Arts or Science (BA/BS) in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering with a minimum of five (5) years SAS programming experience in a clinical trial environment.</li></ul> Required Experience and Skills: <ul><li>Experience with study data standards CDISC (SDTM)</li><li>Experience in SAS and clinical programming.</li><li>Knowledge and experience in developing analysis and reporting deliverables for Research & Development projects (data, analysis, tables, graphics, listings)</li><li>Excellent communication and negotiation skills / excellent teamwork and collaboration</li><li>Excellent written and verbal, and presentation skills; effective technical writing, able to convert complex ideas and information into simple readable form.</li><li>A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders.</li><li>Solid project management skills</li><li>Demonstrated success in the assurance of deliverable quality and process compliance.</li><li>Familiarity with statistical and clinical data management concepts</li></ul> Preferred Experience and Skills: <ul><li>Strong working knowledge of reporting processes Standard Operating Procedure (SOP) and software development life-cycle (SDLC)</li><li>Experience ensuring consistency across protocols and projects.</li><li>Strategic thinking ability to turn strategy into tactical activities.</li><li>Ability and interest to work across cultures and geographies.</li><li>Ability to complete statistical deliverables using global outsource partner programming staff.</li><li>Experience developing and managing a project plan using Microsoft Project or similar package.</li><li>Active in industry forums and professional societies</li><li>Experience in process improvement.</li><li>Knowledge of Metadata Repositories (MDR)</li></ul>BARDS2020 SPjobs eligibleforERP VETJOBS #EBRG 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. Residents of Colorado Click here to request this role's pay range. 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: $111,400.00 - $175,300.00 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): NA Requisition ID:R292245

Senior Scientist, Study Data Tabulation Model Statistical Programming (Hybrid)

Job Description The Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific drug/vaccine program. Develops and manages project plans which span from protocol development through database lock, archiving, and submission deliverables where applicable. Collaborates with appropriate functional areas to align resources and ensure all aspects of the project plan are executed on time and with appropriate quality. Agrees/arbitrates deliverable-based commitments based on detailed knowledge of trial complexity and requirements. Manages change, customer, and stakeholder expectations, facilitates cross-functional decision making, and performs risk management. Represents functional areas and GDMS on cross-functional trial teams and in other trial-level development forums. Under the guidance of more senior staff, may serve as the data management lead or perform a support role for filing programs. Participates in the development of, and ensures adherence to, our company's clinical data management procedures. Interacts with staff across sites, countries, and time zones. Primary activities include but are not limited to: 1. Develops detailed project plans for the collection, review, and cleaning of all clinical data for assigned trials within a specific drug / vaccine program. Data includes, but is not limited to, case report form (CRF) data, lab data, other external data, biomarker data, and clinical outcomes assessments. 2. Serves as project manager of all clinical data management activities for trials as assigned. Under the guidance of more senior staff when appropriate, uses excellent interpersonal, negotiating, and project management skills to perform and manage the following tasks:<ul><li>Project planning, initiation, execution, change control, and closing.</li><li>Project team development, project team leadership, meeting management, and resource coordination.</li><li>Risk management planning (i.e., risk identification, analysis, response planning, monitoring, and control), including escalation as necessary.</li></ul><ul><li>Management of customer / stakeholder expectations; facilitation of cross-functional decisions.</li></ul>3. Defines trial-level requirements for quality data collection and validation at the trial level.<ul><li>Reads and interprets the clinical protocol from a clinical data management perspective.</li><li>Provides clinical data management input into trial design, as appropriate, ensuring operational feasibility.</li><li>Engages with key stakeholders and subject matter experts to assess complexity, define trial-level data management requirements and inputs (including timing), and confirm all data management deliverables and services required for a trial.</li><li>Ensures appropriate use of standards and project-level consistency of database design, data collection, and validation.</li><li>Facilitates assessment and processing of standards and change requests.</li><li>Approves trial-level data validation plan (including project and protocol specific data validation elements).</li></ul>4. Manages trial-level data quality and completion of database lock and post-database lock activities:<ul><li>Monitors overall status and quality of data being collected during the in-life portion of a trial.</li><li>Engages with key stakeholders and subject matter experts to refine data management tools and validation plans, as appropriate.</li><li>Ensures activities required to achieve database lock (or data extraction) are completed by appropriate, responsible functional area.</li><li>Ensures timely archival of trial data and documentation.</li><li>Ensures timely decommissioning of clinical data management technologies.</li></ul>5. Accountable for ensuring the successful execution of delivery of data management services provided by external partners engaged for outsourced trials, as assigned. 6. Supports site and sponsor audits, as appropriate. 7. Identifies and supports improvements to data collection and data management processes and tools Education/Experience (ex-Us, subject to local requirements) : <ul><li>B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline, with at least 3 years' experience in Clinical Data Management, medical research, or database design and development, with at least 1 year experience working with formal project management tools and processes.</li></ul>OR<ul><li>Associates Degree with at least 5 years' professional experience in clinical data management. Medical research, or database design and development, with at least 1 year experience working with formal project management tools and processes.</li></ul>OR<ul><li>High School Diploma (or equivalent) with at least 8 years' professional experience in clinical data management.</li></ul>Knowledge and Skills: <ul><li>Understanding of the clinical research process with in-depth knowledge of the Clinical Data Management lifecycle. Familiar and comfortable with database concepts and tools to manage, extract, and report data. Strong organization, leadership, and management skills. </li><li>Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas. </li></ul>MSJR #EligibleforERP MRLGCTO #ONEGDMS 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: $111,400.00 - $175,300.00 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: 1st - Day Valid Driving License: No Hazardous Material(s): No Requisition ID:R292393

Data Management Trial Manager (Hybrid)

Job Description As a key member of the General Medicine Global Clinical Development team, the Vice President/ Therapeutic Area (TA) Head's primary objectives will be to:<ul><li>Develop and create a new Center of Excellence within the Atherosclerosis & Metabolism TA that will continue to expand our efforts around atherosclerosis, metabolism, obesity, and metabolism-associated liver diseases.</li><li>Create, develop, and implement a successful Therapeutic Area strategy that will bring forth programs to successful approval and registration.</li><li>Lead late-stage development for our company's assets in this TA by overseeing Product Development Teams (PDTs) and collaborating with Section Heads, PDT Leaders, and Clinical Directors responsible for the design and medical monitoring of clinical studies.</li><li>Ensure optimal design and monitoring of clinical programs and studies, producing high-quality clinical documents and presentations.</li><li>Collaborate with functional area leaders within our Research and Development Division (R&D) and across the company enterprise to ensure optimal decision-making and operational excellence in the late development of assets.</li><li>Serve as a role model for our company's Leadership Principles, setting ambitious goals, promoting cross-functional collaboration, and delivering results.</li><li>Establish effective connections with internal and external scientific leaders and key stakeholders.</li><li>Play a key role in therapeutic-related business development decisions.</li></ul>Role Responsibilities:<ul><li>Develop and implement a portfolio strategy in collaboration with cross-functional teams.</li><li>Advance the pipeline and manage the integration of in-licensed assets and acquisitions.</li><li>Drive business development activities to support the therapeutic area pipeline.</li><li>Serve as the senior company representative on joint development committees for selected partnered assets, developing and representing an aligned cross-PDT development strategy.</li><li>Recruit and mentor top talent, providing managerial oversight to Clinical Directors and Section Heads in the Therapeutic Area.</li><li>Represent development activities within the Therapeutic Area internally and externally.</li><li>Contribute to the GenMed Leadership team and the broader Development Leadership team.</li></ul>Education:<ul><li>Medical Degree with significant expertise (BC or BE) in Endocrinology, Diabetology, Hepatology, or Cardiology.</li><li>At least 15 years of relevant industry experience, including building and leading effective teams.</li><li>An additional advanced degree (PhD or other) in a relevant scientific discipline is a strong plus.</li></ul>Required Experience and Skills:<ul><li>Multiple/varied experiences bringing a product through all cycles of drug development, including product licensure.</li><li>Broad experience in the pharmaceutical/biotech industry, particularly in metabolism and/or atherosclerosis portfolio.</li><li>Proven track record in aligning global medical strategies with corporate goals and providing critical therapeutic area insights.</li><li>Recognized clinical research expert in areas such as atherosclerosis, MASH/MASLD, obesity, diabetes, and other cardiometabolic diseases.</li><li>Depth and breadth of knowledge and understanding of scientific, medical, and regulatory environments, practices, and requirements.</li><li>Demonstrated ability to lead and inspire teams, allocate resources strategically, and attract, retain, engage, and develop top talent.</li><li>Excellent communication and influencing skills in cross-cultural and cross-functional matrix settings.</li><li>Proven track record of people management, leadership, and motivational skills.</li><li>Superior stakeholder management skills across scientific, academic, regulatory, and scientific communities.</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: $396,700.00 - $624,400.00 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: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Requisition ID:R287830

VP/TA Head, Global Clinical Development - Atherosclerosis & Metabolism

Job Description Our Animal Health Marketing team takes a customer centric perspective using customer feedback and market intelligence data. Using this data, we design, develop and deploy products, platforms, brands and marketing initiatives that ensure we can improve the health and well-being of animals everywhere. This position is field based with primary responsibilities in (IA, SD, MN) and is responsible for providing technical support to Sales and Marketing for our Company's Animal Health products specific to the US Cattle business, with a primary focus on the Dairy Industry. Responsibilities include providing technical support for Ruminant products and programs, including response to product inquiries and adverse reports in accordance with internal, FDA, CFIA and USDA regulatory policies. The position will require developing trial protocols, monitoring and summarizing clinical and marketing support trials specific to Ruminant animal health. Position will be required to maintain contact with key industry professionals to include academic, veterinary related individuals or groups. Additional duties will include attending and presenting in prominent industry scientific meetings. Deliver a high level of technical expertise, service and support to our Company's Animal Health Division Ruminant sales in North America. Assure those services are provided within corporate objectives and within budget guidelines. Technical service includes but is not limited to:<ul><li>Involvement in the development of new products, development of vaccination programs and protocol for use of pharmaceuticals, product use directions, adverse event reporting, dealing with Ruminant health issues in customer's operations, customer complaints and education on new products from our Company's Animal Health Division.</li><li>Travel will compose at a minimum 50% of incumbent's time. Travel responsibilities will be prioritized by value of customer and return of travel investment.</li><li>Participate as a scientific speaker on the agenda of key Ruminant industry meetings where needed by communicating non-proprietary company research and representing our Company's Animal Health Division as a source of highly valuable technical expertise, with a primary focus on the dairy industry.</li><li>Assist research and development team with product evaluation, licensing trials and product development for all of our Company's Animal Health Division products. Perform field trial evaluation of newly license products to offer technical support information for those particular products.</li><li>Obtain information regarding customer needs through various channels, networking and customer visits, providing feedback to prioritize research and development needs</li><li>Work with the marketing team on key business initiatives to aid in development of technical and marketing brochures for our Company's Animal Health Division products.</li><li>Act as a liaison between prominent researchers in university, government and private settings to supply our Company's Animal Health Division with a stream of information regarding innovative products and developments within the research world.</li><li>Communicate between various Animal Health departments, as needed, to aid in delivery of product to customers, i.e. International Registration, Quality Control, Quality Assurance, Production, etc.</li><li>Provide Sales force training as well as guidance on product implementation for external customers.</li></ul>Education Minimum Requirement:<ul><li>Must have a Doctor of Veterinary Medicine (D.V.M) degree and (or) PhD in Cattle specific animal science. </li></ul>Preferred Experience and Skills**:<ul><li>Must have minimum of 2 years related dairy cattle veterinary and/or animal science experience.</li><li>Excellent verbal and written communication skills.</li><li>Strong interpersonal skills.</li><li>Ability to work in a team environment</li><li>Good leadership skills</li><li>Ability to digest extremely technical information and present it in understandable terms to lay people.</li></ul>Preferred Experience and Skills:<ul><li>Field experience in dairy cattle production and/or ruminant medicine preferred</li><li>If the successful candidate is a DVM and a license in at least one state is preferred but not required</li><li>Fluent in English and Spanish</li></ul>#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". 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: 50% Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: Yes Hazardous Material(s): n/a Requisition ID:R291621

Ruminant Technical Services Manager (IA, SD, MN)

Job Description Our Research Laboratories in our Rahway, New Jersey are focused on the discovery and development of world-changing therapeutics. Co-located with the corporate headquarters, our multi-disciplinary research site offers cutting edge technology and resources to explore the most promising science combined with our company's world-class R&D expertise for inventing medicines. Located in the greater New York City metropolitan area, research conducted in our state-of-the-art facility drives all aspects of drug discovery, development, manufacture, and commercialization of small molecules, biologics, and vaccines. At our company, we are inspired by the belief that a research-driven enterprise dedicated to scientific excellence can create medicines and vaccines that save and improve lives. Every employee is building on our proud legacy of scientific breakthrough to impact the lives of patients, which relies on the integrity, creativity, humility, and scientific acumen of our team. We are creating a diverse organization that is inspired by invention and founded on a culture of respect and collaboration. At our Research Laboratories, you will have the opportunity to expand your knowledge and skills through collaboration with talented and dedicated colleagues while advancing your career. Job Description: We are seeking an exceptional scientist with a passion for talent development to lead our Targeted Protein Degradation (TPD) group located in our Rahway, NJ and translate advances in TPD technologies to the invention of innovative and novel therapeutics. The successful candidate will have extensive pharmaceutical discovery experience and a proven track record of advancing TPD technologies and capabilities. The director will require exceptional communication and leadership skills and take on broad responsibilities that will include departmental strategy, pipeline impact, and talent development. The scientist in this role will work collaboratively with colleagues across functional and therapeutic areas to develop and progress a portfolio of TPD programs. The responsibilities of this position will also include participation in departmental recruiting, resource management, external collaborations, and governance committees. The director will lead, coach, mentor, and support the career development of a team of talented scientists, while promoting diversity and inclusion initiatives and supporting a culture of innovation within the department. Education Minimum Requirement: <ul><li>Ph.D. in chemistry, chemical biology, or related field</li></ul> Required Experience and Skills: <ul><li> A minimum of 7 years of experience in drug discovery with experience leading TPD programs </li><li>Leadership experience developing targeted protein degradation technologies and therapeutics</li><li> Experience training and mentoring other scientists </li></ul> Preferred Experience and Skills: <ul><li>Leadership experience developing targeted protein degradation technologies and therapeutics</li><li>Experience in discovery program leadership and influencing strategy across disciplines and organizational boundaries.</li><li>Strong written and verbal communication skills and excellent leadership and collaboration skills</li><li>Ability to utilize creativity and innovation in problem solving</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: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Requisition ID:R291996

Director, Targeted Protein Degradation (TPD), Rahway Discovery Chemistry

Job Description The Executive Director of Cardiovascular (Cardio-renal disease & Heart Failure) will be responsible for overseeing and facilitating research in cardiovascular disease with an emphasis on cardio-renal disease & heart failure, in the Cardiometabolic Disease (CMD) Discovery Biology Department, which is located at a new state-of-the-art center in South San Francisco, CA. The Executive Director will contribute to the design, prioritization, and execution of the strategic plan within CMD, including integration of new technology platforms, pre-clinical models, human biology, data science, while focusing on uncovering novel biology that delivers high-quality drug discovery pipeline. We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science" and that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. Primary Responsibilities:<ul><li>Lead and help shape the departmental strategy in cardiovascular disease with an initial focus on cardio-renal & heart failure</li><li>Implement the strategy working together with key stakeholders within the department and across the network, in addition to collaborating with key opinion leaders in academia</li><li>Lead the development and implementation of in vitro and in vivo assays to conduct investigation of disease biology to establish and support evolution of a robust pipeline of cardio-renal diseases and heart failure therapeutic targets</li><li>Manage and mentor a team of scientists in cardiovascular disease research</li><li>Review and seek out potential external research collaborations and licensing opportunities to capitalize on novel insights and complement internal pipeline</li><li>Monitor emerging biology and basic & clinical research within cardio-renal diseases & hear failure, and more broadly across the scientific spectrum</li><li>Champion diversity and inclusion within the department and across the broader organization</li><li>Recruit, develop, and retain a talented team that delivers on target identification & validation and advances CMD pipeline</li></ul>Education:<ul><li>Ph.D., MD, or MD/Ph.D. in a cardiometabolic related discipline and relevant experience</li></ul>Required Experience and Skills:<ul><li>A minimum of 10 years' research experience in cardio-renal biology, heart failure, with a proven track record substantiated by peer-reviewed publications</li><li>Research & development experience within academia and/or industry setting</li><li>Experience in overseeing research projects, setting priorities and trouble shooting in a multi-disciplinary environment</li><li>Broad knowledge and first-hand experience in cardiovascular in vitro and in vivo models</li><li>Solid understanding of drug discovery and clinical development and working knowledge of biomarker discovery, translational research, data science and human genetics</li><li>Exceptional partnering and team skills as a trusted colleague and team leader; record of accomplishment of leading and supporting a collaborative team</li><li>Excellent track record of providing mentorship and guidance to reports and peers</li><li>Proficient in utilizing innovative technologies for preclinical research</li><li>Ability to communicate effectively with and relate to a broad range of stakeholders, including senior leaders, peers, direct reports, partner organizations and external collaborators</li></ul>Preferred Experience and Skills:<ul><li>Prior industry experience</li><li>Ability to understand, analyze and interpret complex problems and data while developing appropriate action plans to achieve results</li><li>Strong leadership skills to build and lead an agile team. Ability to successfully influence, build credibility and work effectively with a diverse range of stakeholders and both internal and external partners</li><li>A team player, who works effectively in a matrix organization, collaborates functionally across multiple stakeholders, and builds trust and credibility at all levels. Someone who builds consensus and achieves agreement on key priorities</li><li>High-level of business acumen and judgment is preferred for this role; ability to make practical, realistic, data-driven, and timely decisions</li><li>Encourages and maintains the highest quality and rigor of research output and commitment to scientific inquiry, ethics, and diversity</li></ul>#EligibleforERP 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: $247,700.00 - $390,000.00 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/International VISA Sponsorship: Yes Travel Requirements: 25% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Requisition ID:R281360

Executive Director, Cardiovascular

Job Description Associate Principal Scientist, Small Molecule Research & Development In your role as Associate Principal Scientist, you will be part of a team developing innovative analytical methodologies for early to late phase programs with application to drug substance and a broad array of drug product dosage forms, combination products and modalities through analytical characterization, imaging tools, and data analysis. You would also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities, which are in no particular order and are by no means complete, include: Primary Responsibilities <ul><li>Drive solutions to development challenges for small molecules, peptides and oligonucleotides through active collaboration with cross functional project teams and external vendors.</li><li>Design scientific studies to inform the selection of early development and market formulation compositions and manufacturing processes using conventional and novel analytical technologies and document in a detailed manner.</li><li>Develop and implement analytical methods utilized for both development as well as methods for the release and shelf-life assessment of clinical supplies under good manufacturing practice (GMP) settings.</li><li>Author investigational new drug (IND), investigational medicinal product dossier (IMPD), and new drug application (NDA)/ worldwide marketing application (WMA) submissions as well as responding to agency questions.</li></ul><ul><li>Strong collaboration with internal stakeholders and partners.</li><li>Analytical leadership on both drug development within the pipeline and innovative technology teams defining the dosage forms and analytical characterization tools of the future.</li><li>Present results of experiments and innovation efforts to teams and internal governance bodies.</li><li>Scientific supervision and day-to-day oversight of junior analytical scientists.</li><li>Be a leader within the external scientific community in professional organizations, conferences, and publications as well as analytical technology and regulatory sciences related focus groups and consortia.</li></ul> Education Minimum Requirements: <ul><li>BS + 10 years' experience, MS + 7 years' experience, or PhD + 3 years' experience in Chemistry, Pharmaceutical Sciences, other Life Sciences, or equivalent with analytical measurement and characterization experience.</li></ul> Required Experience and Skills: <ul><li>A proven record of strong technical problem solving, and innovative research experience supported by scientific publications.</li><li>Excellent written and oral communication skills, as well as interpersonal skills, are necessary to qualify for this role.</li></ul> Preferred Experience and Skills: <ul><li>Though not required, the ideal applicant would have hands-on experience in advanced chromatographic separation science, spectroscopy analysis, and other analytical techniques.</li><li>In addition, experience with data science, dissolution, and LCMS are also a plus.</li></ul>#AR&D #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: $135,500.00 - $213,400.00 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: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Requisition ID:R291629

Associate Principal Scientist

Job Description In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. This position supports statistical programming activities for multiple and/or late stage drug/vaccine clinical development projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation. The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables. For assigned projects the position serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle. Primary Activities :<ul><li>Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices.</li><li>Maintain and manage a project plan including resource forecasting. </li><li>Coordinate the activities of a global programming team that includes outsource provider staff.</li><li>Membership on departmental strategic initiative teams</li></ul> Education and Minimum Requirement : BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9 years SAS programming experience in a clinical trial environment. MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 7 or more years SAS programming experience in a clinical trial environment. Department Required Skills and Experience: <ul><li>Excellent interpersonal skills and ability to negotiate and collaborate effectively.</li><li>Excellent written, oral, and presentation skills</li><li>Broad knowledge and significant experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)</li><li>Strong project management skills; leadership at a program level; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders.</li></ul> Position Specific Required Skills and Experience: <ul><li>Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise.</li><li>Experience leading large and/or complex statistical programming projects that include coordinating the activities of a programming team.</li><li>US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables.</li><li>Designs and develops complex programming algorithms.</li><li>Ability to comprehend analysis plans which may describe methodology to be programmed, an understanding of statistical terminology and concepts.</li><li>Familiarity with clinical data management concepts</li><li>Experience in CDISC and ADaM standards</li><li>Demonstrated success in the assurance of deliverable quality and process compliance.</li><li>Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices.</li><li>Ability to anticipate stakeholder requirements.</li></ul>** Preferred Skills and Experience: <ul><li>Strong working knowledge of reporting processes (SOPs) and software development life cycle (SDLC)</li><li>Experience providing technical and/or programming guidance and mentoring to colleagues.</li><li>Ability and interest to work across cultures and geographies.</li><li>Ability to complete statistical programming deliverables through the use of global outsource partner programming staff.</li><li>Experience developing and managing a project plan using Microsoft Project or similar package.</li><li>Active in professional societies</li><li>Experience in process improvement.</li></ul> #EligibleforERP BARDS2020 SPJOBS VETJOBS #EBRG 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: $135,500.00 - $213,400.00 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: No Travel Required Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Requisition ID:R279017

Associate Principal Scientist, Statistical Programmer | Oncology (Hybrid)

Job Description FLEx is a set of multi-modality Drug Product development and GMP clinical manufacturing assets being constructed in the Rahway, New Jersey site, to support our company's diverse and growing pipeline of oral and injectable therapeutics and vaccine drug products. Operational leadership of the FLEx complex is shared across two co-leader roles, and includes operations that support end-to-end GMP clinical supply manufacture and product/process development, as well as oversight of the Enterprise Resource Planning systems (SAP, PAS-x) and the Data Analytics output of those areas. The RY119, RY53 and RY80B facilities are fully operational, along with the non-sterile portion of the RY880 building. The sterile portion of RY880 is in commissioning/qualification/validation. Successfully delivering on the entire scope of FLEx, including the qualification and validation work in the RY880 sterile modality, is a key near-term focus for the FLEx Co-Leads. The FLEx Co-Leads are jointly accountable for all activities associated with FLEx, including the realization of the overall FLEx intent in Pharmaceutical Sciences and Clinical Supply (PSCS) organization. This includes operating model, culture, talent development, technology introduction, and compliance. However, one co-lead remains focused on non-sterile pipeline programs and infrastructure while one co-lead remains focused on sterile pipeline programs and infrastructure. The FLEx Co-Lead role is based in New Jersey and reports to the Associate Vice President of Pharmaceutical Operations and Clinical Supply in our Research and Development Division (R&D). The current opening is focused on the non-sterile pipeline and infrastructure. The FLEx Co-Leads are responsible for providing tactical and strategic level direction to the cross-functional teams working in the set of FLEx assets in RY880, RY53, RY53 and RY80B. This extends from materials management, weigh and dispense, GMP manufacture, formulation development, and bulk Drug Product release. Close connectivity with upstream Drug Substance and downstream packaging partners is required to optimally support clinical development and product commercialization. The FLEx Co-Leads are responsible for creation and management of the performance management processes that govern operations, including tier, clinical siting and compliance councils. Key performance indicators range from quality and regulatory compliance, operational excellence, pipeline program support, financial, talent development and diversity/equity/inclusion. Key to the realization of FLEx is the creation of a collaborative scientific community that inspires innovation and enables speed of new product development from clinical research to commercialization of robustly understood products and processes. The FLEx Co-Leads have direct management responsibilities for a staff that is expected to grow to >150 FTEs and contractors in the 2-year window, along with a matrixed reporting relationship to functional groups in development, quality, safety, facilities management, analytical, finance and regulatory. FLEx was designed to be a facility that evolves to meet company and pipeline needs over its entire lifetime. As such the FLEx Co-Leads are responsible for understanding the external and internal drivers of change, translating that to a local FLEx strategy, securing support for that strategy with partners and R&D Senior Leadership, and executing on plans to deliver the strategy. This is inclusive of business process development, governance structure, talent development, innovation and delivery of technology, and defining the cultural attributes required for the area's success. Significant focus will be placed on adoption of new digital capabilities that allow for better access to high-fidelity data, more efficient clinical product release, improved product/process characterization, and more successful commercialization of new products into our Manufacturing Division. Primary Responsibilities include but are not limited to:<ul><li>Setting of the strategic vision for FLEx aligned to the PSCS and R&D strategies, and the long-range operating plan to achieve that vision.</li><li>Overseeing operations in the set of FLEx assets, through a thoughtful and engaging tier process jointly managed with partner groups in R&D, Manufacturing, Global Safety and Environment (GSE) and Global Workplace and Enterprise Services (GWES). Establishing an end-to-end mindset and value stream for delivering clinical supplies agilely to ensure speed to clinic and best filing process.</li><li>Creating an entrepreneurial culture in FLEx which values diversity in all its forms as a catalyst to innovation and product creation, recognizes the freedom to experiment and fail, is a safe environment to challenge, nurtures a keen sense of belonging, and motivates all to achieve their potential.</li><li>Collaborating with peer leaders in R&D, Manufacturing and Corporate, from Discovery to commercial manufacturing, and across the product value stream, to anticipate pipeline needs, prioritize facility on critical business needs.</li><li>Establishing and managing financial budgets and forecasts associated with the FLEx assets, both with respect to expense and capital expenditure.</li><li>Defining and demonstrating operational excellence in a clinical manufacturing setting, across a spectrum of activities and inclusive of capital project delivery. </li><li>Creating ERP/MES/Data systems that allow scientists to fully access available data via intuitive interfaces, to facilitate process development, streamline clinical supply and improve efficiency of operations. </li><li>Maintaining FLEx facility and equipment systems in a state of permanent inspection readiness.</li><li>Recruitment and developing of staff, through close partnership with external and academic partners, thoughtful objective setting including stretch leadership and/or technical assignments that deepens skillsets, learning opportunities that broaden experience and a comprehensive rewards and recognition system that promotes success across a range of technical and behavioral dimensions.</li><li>Member of site and global leadership committees (e.g. safety, quality).</li></ul>Education:<ul><li>BS or MS degree in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Materials Science, Mechanical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, or a related field with 10 years of relevant experience</li><li>Or, PhD in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Materials Science, Mechanical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry or a related field with 8 years of relevant experience</li></ul>Required Experience and Skills:<ul><li>Critical Skills<ul><li>Minimum 2 years of management responsibility and experience developing staff</li><li>Fluency in the clinical quality management system and CMC process, across modalities and inclusive of facility/technology development and qualification</li><li>Effective communication and collaboration skills, with a diverse group of stakeholders both inside and outside FLEx</li><li>Demonstrated project management skills</li></ul></li></ul><ul><li>Critical Behavioral and Leadership Competencies<ul><li>Cultivates cross-functional collaboration, networking, and partnership</li><li>Change catalyst, able to lead organizational change and champion a learning culture</li><li>Sound business decision making</li><li>Entrepreneurial mindset, focus on delivering customer value</li></ul></li></ul><ul><li>Personal Attributes and Characteristics<ul><li>Demonstrated interest working in a diverse and constantly changing environment</li><li>Resilient and able to coach others to be resilient</li><li>Detail oriented and organized</li><li>Ability to inspire and motivate others in a team environment</li></ul></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: $220,700.00 - $347,500.00 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: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Requisition ID:R291845

Executive Director, Engineering - FLEx Co-Lead

Job Description Senior Associate, Administrative Assistant The Senior Administrative Associate will support a team consisting of an Associate Vice President and Senior Directors in the Neuroscience Therapeutic Area, Global Clinical Development. This role assists with administrative functions relating to organization and communication across the team and ensures the efficient operation of the office and its team members. The position requires excellent organizational skills, professional communication skills, attention to detail, flexibility, and teamwork. Responsibilities and Primary Activities<ul><li>Manages complex calendars, prepares correspondence and reports, and reliably handles confidential issues</li><li>Often serves as an initial point of contact for and liaison to outside visitors, clients, and vendors</li><li>Coordinates and performs multiple tasks while understanding the project principles and technical skills related to own work assignments</li><li>Prioritizes work activities with little supervision</li><li>Schedules complex, multi-leg, and international travel</li><li>Supports the use of Team Sites</li><li>Communicates and interacts effectively with Our Company executives and internal/external clients both onsite and remotely to maintain workflow</li><li>Coordinates special projects within the division or area</li><li>Consistently demonstrates Company Leadership behaviors</li><li>Experience scheduling complex travel arrangements, including multi-leg domestic and international travel</li><li>Demonstrated experience with visa and passport processing</li><li>Ability to handle and prioritize many simultaneous assignments</li><li>Experience with event planning and coordination</li><li>Extraordinary attention to detail</li><li>Outstanding communication and people skills</li><li>Experience with financial and budget tasks</li><li>Proactively takes initiative</li></ul>Required Qualifications, Skills, & Experience Minimum<ul><li>High school diploma</li><li>8+ years of administrative assistant experience</li><li>Advanced ability using Microsoft Office Suite (Outlook, Word, Excel, Power Point) and ability to operate other peripheral devices</li><li>SAP experience processing Expense Reports, Ariba experience for Purchase Orders, Payment Requests, Vendor Add Forms, as well as the capability to run reports within SAP</li><li>Advanced analytical ability, independent judgment, creativity, and problem-solving capabilities</li></ul>Preferred<ul><li>Advanced education or certifications (e.g., Certified Administrative Professional, Project Management Professional Certification, Professional in Human Resources Certification)</li><li>3+ years executive administrative experience supporting senior executives (Senior Director, Executive Director, Vice President, or above)</li></ul> ETJOBS MSJR 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: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): NA Requisition ID:R291552

Senior Associate, Administrative Assistant (Hybrid)

Job Description Position Description: Associate Clinical Research Manager (aCRM) - Oncology With support of other Clinical Research Manager's (CRMs) and/or TA-Head/CRD, this role is accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, Our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. The aCRM could be responsible for a particular study for a country or a cluster. Responsibilities include, but are not limited to:<ul><li>Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).</li><li>Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.</li><li>Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Our Company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.<ul><li>o Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA-Manager and/or functional vendor and internal management as needed.</li><li>o Performs Quality control visits as required.</li></ul></li></ul><ul><li>Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTCs, CRAs and COMs).</li><li>Responsible for creating and executing a local risk management plan for assigned studies.</li><li>Ensures compliance with CTMS, eTMF and other key systems in assigned studies.</li><li>Escalates as needed different challenges and issues to TA-Head/CRD/CCQM and or CTT (as appropriate).</li><li>Identifies and shares best practices.</li><li>Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.</li><li>As a customer-facing role, this position will build business relationships and represent our Company with investigators.</li><li>Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD, TA-Head and Regional Operations.</li><li>Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Regulatory Affairs, Global Medical and Scientific Affairs to align on key issues/decisions across the trials. Consult with Human Health as needed.</li></ul>Extent of Travel: Up to 30% of working time Position Qualifications : Education Minimum Requirement: <ul><li>Bachelor degree in Science (or comparable)</li><li>4+ years of experience in clinical research</li><li>Oncology experience preferred</li></ul>Required Experience and Skills: <ul><li>Knowledge in Project Management and/or site management.</li><li>Strong organizational skills with demonstrated success in related role or discipline required.</li><li>Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight and supervision of the TA-Head or CRD.</li><li>Requires understanding of local regulatory environment.</li><li>Scientific and clinical research knowledge is required.</li><li>Understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.</li><li>Ability to function as a key link between Country Operations and Clinical Trial Teams.</li><li>Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions.</li><li>Ability to manage processes (and controls), productivity, quality and project delivery.</li><li>Proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication.</li><li>Strategic thinking.</li><li>Ability to work efficiently in a remote and virtual environment.</li><li>Aptitude for building leadership skills that enable and drive alignment with the goals, purpose and mission of our Research & Development Division , Global Clinical Development (GCD) and GCTO.</li><li>Ability to identify problems, conflicts and opportunities early, analyses and prepare mitigation plans and drive conflict resolution is critical.</li><li>Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum disruption. Examples of common problems include: 1) low patient recruitment, 2) inadequate staff to meet business needs, 3) performance or compliance issues, and 5) resolution of conflictive situations.</li><li>Understand cultural diversity.</li><li>Strong diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders.</li></ul> MRLGCTO #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: $111,400.00 - $175,300.00 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: No Travel Required Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Requisition ID:R290970

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