*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 Accounts Receivable Professional Indianapolis, IN (Hybrid) An exciting opportunity has arisen for an Accounts Receivable Professional to work for North American Finance Service Centre (NAFSC) which is one of three Finance Service Centers at Rolls-Royce and a part of Finance Operations in Global Business Services. The Finance Service Centers provide transactional finance support for and on behalf of Rolls-Royce Finance and the wider business. With departments of Financial Accounting and Reporting (FA&R), Accounts Payable (AP) and Accounts Receivable (AR), the Service Centers are integral to Rolls-Royce's finance strategy in ensuring that transactional finance processes are delivered efficiently and effectively both to meet customer requirements and in order to enable scalable future growth and expansion. The Accounts Receivable Professional will work as part of the North American Finance Service Center (NAFSC) and will be responsible for a variety of tasks related to transacting key business processes on behalf of many of our North American businesses. This role is part of the Credit & Collections team within the NAFSC, which allows for cross training on several tasks supporting several business transactions. Dream Big and Make an Impact At Rolls-Royce, we pioneer technologies that deliver the cleanest, safest and most aspiring solutions to our planet's vital power needs. We embrace the power of data and technology and aim to be Digital First in everything we do. Every great product needs a great business behind it. Our work is complex, innovative, highly challenging and rewarding, and it takes a range of professionals to do it. Having the right people means we can deliver excellence to our customers. Rolls-Royce is a Military Friendly Employer. We evaluate qualified you without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. You can learn more here . Key Accountabilities: <ul><li>Coordinating and clear cash receipts and ensure their correct accounting and reconciliation through to the GL</li><li>Contacting customers to confirm timely payment, resolving customer issues originally as well as in conjunction with the appropriate finance business partner and/or commercial team member</li><li>Update FSCM to record customer contacts, disputes and payment promises and compile overdue debt progress reports with appropriate commentary to support debt meetings</li><li>Monitor A/R shared mailbox daily to ensure all sales orders are released (if appropriate) before the end of business day</li><li>Complete assigned month-end close tasks such as reconciliation of accounts, review of unapplied cash and send customer statements</li></ul> Basic Requirements: <ul><li>Associate degree with 2 + years of accounting experience OR</li><li>Bachelor's Degree and 1+ years of accounting experience OR</li><li>Masters Degree in accounting OR</li><li>Experience in Lieu of degree with 5 + years of accounting experience</li><li>To be consider for this role you must be a US Citizen</li></ul> Preferred Requirements: <ul><li>Current experience with SAP</li><li>Previous experience working in a fast-paced environment that is highly deadline-passionate</li><li>Previous accounts receivable experience</li><li>Proficient in Excel (VLookup, Pivot Tables, Macros)</li></ul>Pioneer the next generation of innovation. Join us and you'll develop your skills and expertise to the very highest levels, working in an international environment for a company known the world over for its brilliance. Our People are our Power We are an equal opportunities employer. We're committed to developing a diverse workforce and an inclusive working environment. We believe that people from different backgrounds and cultures give us different perspectives. And the more perspectives we have, the more successful we'll be. By building a culture of respect and appreciation, we give everyone who works here the opportunity to realize their full potential. You can learn more about our global Inclusion strategy here . Relocation assistance is not available. Close Date: May 28th, 2024 Job Category Finance Job Posting Date 21 May 2024; 00:05 Pay Range $50,918-$76,378-Annually Location: Indianapolis, IN Benefits Rolls-Royce provides a comprehensive and competitive Total Rewards package that includes base pay and a discretionary bonus plan. Eligible employees may have the opportunity to enroll in other benefits, including health, dental, vision, disability, life and accidental death & dismemberment insurance; a flexible spending account; a health savings account; a 401(k) retirement savings plan with a company match; Employee Assistance Program; Paid Time Off; certain paid holidays; paid parental and family care leave; tuition reimbursement; and a long-term incentive plan. The options available to an employee may vary depending on eligibility factors such as date of hire, employment type, and the applicability of collective bargaining agreements.

public

Accounting Professional

Job Description Financial Accounting & Reporting Cash Accountant Indianapolis, IN An exciting opportunity has arisen for a Financial Accounting & Reporting Cash Accountant who will handle daily cash accounting and reporting, interaction with other teams and personnel within the NAFSC and businesses supported by the NAFSC, and other duties related to financial reporting. Dream Big and Make an Impact The Financial Accounting & Reporting Cash Accountant will work as part of the North American Finance Service Center (NAFSC) and will be responsible for a variety of tasks related to transacting key business processes on behalf of many of our North American businesses. At Rolls-Royce, we pioneer cutting-edge technologies that deliver the cleanest, safest and most competitive solutions to our planet's vital power needs. We embrace the power of data and technology and aim to be Digital First in everything we do. Every great product needs a great business behind it. Our work is complex, innovative, highly challenging and rewarding, and it takes a range of professionals to do it. Having the right people means we can deliver excellence to our customers. Rolls-Royce is a Military Friendly Employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. You can learn more here . Key Accountabilities: <ul><li>Record daily cash transactions and preparing weekly cash reports</li><li>Prepare and/or reviewing miscellaneous payments in online banking systems</li><li>Applying appropriate level of professional skepticism to all financial transactions and task proposed transactions, as necessary, to ensure accurate financial reporting in accordance with accounting standards and group policy</li><li>Performing regular bank account reconciliations. Reconciliations should be completed as a key financial internal structure as well as provide meaningful financial management information to finance business partners</li><li>Reviewing, developing, evaluating and modifying specific accounting procedures to ensure continuous effort to improve operations, decrease turnaround times, streamline work processes and work cooperatively and jointly to provide quality seamless customer service</li><li>Assist with month-end and year-end close, internal and external audit requests, and other ad hoc projects as required</li></ul>Basic Requirements: <ul><li>Associate degree with 3+ years of accounting experience OR</li><li>Bachelor's Degree in accounting experience OR</li><li>Master's degree in accounting OR</li><li>Experience in Lieu of degree with 4 + years of accounting experience</li><li>To be consider for this role you need to be a US Citizen or Permanent Resident</li></ul> Preferred Requirements:<ul><li>Current experience with SAP</li><li>Experience working in a fast-paced environment that is highly deadline driven</li><li>Accounts receivable experience</li><li>Proficient in Excel (VLookup, Pivot Tables, Macros)</li></ul> Pioneer the next generation of innovation. Join us and you'll develop your skills and expertise to the very highest levels, working in an international environment for a company known the world over for its brilliance. We are an equal opportunities employer. We're committed to developing a diverse workforce and an inclusive working environment. We believe that people from different backgrounds and cultures give us different perspectives. And the more perspectives we have, the more successful we'll be. By building a culture of respect and appreciation, we give everyone who works here the opportunity to realize their full potential. You can learn more about our global Inclusion strategy here . Relocation assistance will not be provided for this position. Close Date: May 31st, 2024 Job Category Finance Job Posting Date 21 May 2024; 00:05 Pay Range $50,918-$76,378-Annually Location: Indianapolis, IN Benefits Rolls-Royce provides a comprehensive and competitive Total Rewards package that includes base pay and a discretionary bonus plan. Eligible employees may have the opportunity to enroll in other benefits, including health, dental, vision, disability, life and accidental death & dismemberment insurance; a flexible spending account; a health savings account; a 401(k) retirement savings plan with a company match; Employee Assistance Program; Paid Time Off; certain paid holidays; paid parental and family care leave; tuition reimbursement; and a long-term incentive plan. The options available to an employee may vary depending on eligibility factors such as date of hire, employment type, and the applicability of collective bargaining agreements.

Financial Accounting & Reporting Cash Accountant

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The primary responsibilities of the Manager, Omnichannel Marketing is to support the development, planning and implementation of omnichannel marketing to key customer segments across the portfolio in partnership with brand teams. The Manager should assess external digital opportunities and threats, customer journeys, and channel-specific nuances as key inputs to strategy and implementation. The Manager should support seamless execution of all omnichannel platforms, tools and applications, including but not limited to database, websites, paid media, and CRM. The individual will assess ROI and KPIs and need for enhanced investments. This role is an individual contributor role, and reports to the Director, Omnichannel Marketing. Responsibilities - Support experience journey design and implementation for customers and patients across channels. Evaluate and recommend optimization methods to better connect channels, increase efficiencies, and improve customer experience. Ensure digital best practices are met and brand strategies are maximized through all touchpoints. - Work with IT and external vendor partners to manage user experience across platforms, assisting with problem resolution. Partner with brand teams, key sales, operations and market access personnel, as well as other internal stakeholders to ensure digital, financial and strategic optimization. Ensure customer 360 lens is clearly understood by brand leadership, is incorporated into analytics, is compliant and validated. Act as a champion and change agent in leading the organizational changes required to create and sustain digital capabilities. Foster productive relationships with key cross functional stakeholders. - Manage the day-to-day operations of Omnichannel Marketing for Brand team/s, including all budget-related tracking, project management oversight, legal material review and process compliance, and other issues. Act as a champion and change agent in leading the organizational changes required to create and sustain digital capabilities. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Bachelor's Degree Marketing, Business Administration, or other related area preferred required - MBA Marketing, Business Administration, or related area preferred Experience Qualifications - 4 or More Years Overall related experience required - 1 or More Years Experience in developing and implementing digital/omnichannel marketing strategies required - 1 or More Years Pharmaceuticals Experience including Sales, Marketing, IT or Market Access Leadership or other related area preferred Travel Ability to travel up to 20% Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Manager, Omnichannel Marketing

Join a Legacy of Innovation 110 Years and Counting! Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities. Summary The Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post registration. Responsibilities include the development of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies, conduct hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and Pharmacometrics/ Quantitative Clinical Pharmacology function. The incumbent will champion model-based drug development as an active team member of clinical and development teams. Responsibilities <ul><li>Responsible for all aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead; supports Phase 2/3 clinical pharmacology objectives with high-level supervision; participates in due diligence activities and represents global function on study and project teams</li><li>Produces independent writing for publications & regulatory documents</li><li>Serves as a specialist in PK-PD and Pop PK-PD concepts, phase 1-4 clinical studies, literature, and regulatory guidelines and can conduct/develop PK-PD and Pop PK-PD analyses,</li><li>Participates in KOL and regulatory interactions at project level, interacts with regional and global study and project team members, and to a limited extent with senior management, and outside vendors; works independently for all phases of studies</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education (from an accredited college or university) and Experience Qualifications One of the following is required:<ul><li>PhD in Pharmacology or Pharmaceutical Sciences or PharmD with a clinical pharmacology research fellowship and 4 years of relevant experience. 1 or more years industry experience required.</li><li>Masters' degree with 6 years of relevant experience. 1 or more years industry experience required.</li><li>Bachelor's degree with 8 years of relevant experience. 1 or more years industry experience required.</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Associate Director, Clinical Pharmacology

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Associate Director, Quantitative Systems Pharmacology (QSP) will work within the Quantitative Clinical Pharmacology (QCP) group to develop and apply QSP models to aid in drug discovery/development decisions, which include target prioritization, therapeutic modality selection, biomarker characterization and clinical trial design. In addition, he/she will develop a QSP strategy to address prioritization across the portfolio of compounds within Oncology/Immuno-Oncology. This position requires internal/external cross-functional collaboration to develop and apply QSP models across a portfolio of therapeutic compounds. This includes working with scientists in Research, Translational Science, Clinical Development, in addition to colleagues in QCP. QSP Scientists have the opportunity to work within the QSP Model Development Team (MDT), a formal cross-functional framework for collaborative development and application of QSP within Oncology/Immuno-Oncology. Responsibilities<ul><li>Develop and apply Quantitative Systems Pharmacology (QSP) models to address drug-discovery and development questions</li><li>Develop a QSP strategy to address prioritization across the portfolio within Oncology/Immuno-Oncology</li><li>Collaborate with multidisciplinary project teams to develop and apply QSP models to aid in target prioritization, therapeutic modality selection, biomarker characterization and early clinical trial design</li><li>Interact with, and possibly lead, cross-functional QSP MDT to develop and apply QSP within Oncology/Immuno-Oncology</li><li>Develop and rigorously assess the functionality, feasibility, efficiency and validity of new models</li><li>Conduct extensive literature review to identify suitable mechanistic elements, interactions, rate constants and sub-modules for incorporation into systems (disease) models</li><li>Contribute to the design, execution and interpretation of clinical and non-clinical studies.</li><li>Partner with external groups to accelerate and supplement the internal QSP efforts in key disease indications</li><li>Maintain effective collaboration with internal/external stakeholders across diverse functions to facilitate model development and application.</li><li>Align QSP model deliverables with the Model-Based Drug Development (MBDD) plans</li><li>Utilize virtual population workflows and script-based analysis packages to generate clinically relevant hypotheses to inform clinical development programs</li><li>Stay informed with emerging literature and science in the systems biology/pharmacology modeling and simulation sciences</li><li>Build and maintain a personal track record of publication in the area of QSP</li></ul>Qualifications: Reasonable consideration will be given to candidates with greater experience/qualifications in some areas as compared with others. Education Qualifications (from an accredited college or university) Ph.D. in Engineering, Mathematics, Bioinformatics, Pharmacometrics, Systems Biology/Pharmacology or a related field with a proven record of productivity as demonstrated by publications and conference presentations - required Experience Qualifications<ul><li>3 or more years experience in industry/consulting developing and applying QSP/Systems Biology models</li><li>Understanding of theory, principles and statistical aspects of advanced mathematical modeling and simulation, including numerical methods, parameter estimation/optimization, ordinary differential equations (ODEs) and how these can be applied in the development of complex models of biological pathways/systems</li><li>Experience with strategic application of QSP to address questions in Pharmaceutical R&D</li><li>Excellent oral and written communication skills and the ability to interact effectively with scientists in other disciplines with a positive, collegial and collaborative attitude</li><li>Knowledge of the basic principles of pharmacokinetics and pharmacodynamics</li><li>Ability to quickly learn new areas of biological sciences and build on solid foundation of quantitative skills to develop QSP models</li><li>Some experience in the design of clinical and non-clinical studies used to inform gaps in knowledge to support improved understanding of disease/drug mechanisms to support QSP model development</li><li>Experience with modeling software(s) such as Matlab/SimBiology and Julia is required</li><li>Experience with large-scale disease platform and virtual population workflow is desirable</li><li>Experience with general programming and data analysis tools/languages such as Python or R would be particularly desirable</li><li>Desire to interact as a modeling and simulation expert across clinical development teams with experts from different functional areas in Research and Development</li><li>Familiarity with the challenges and general application of mathematical modeling/simulation in pharmaceutical R&D</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Associate Director, Quantitative Systems Pharmacology

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryProvide strategic leadership for all statistical programming activity related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global harmonization of programming processes supporting global submission. Responsibilities - Statistical Programming Management: Coordinates outsourced statistical programming of analysis data sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth knowledge of regulatory authority's requirements. Typically has administrative responsibility for recruiting, retaining, developing, and managing employees. Guide career growth and provide development opportunity for statistical programmers. Manages contract statistical programming staff to ensure proper resource allocation for achieving successful project deliverables. Provides oversight of all statistical programming activities performed by contractors in different oncology trials as well as submission-related activities, e.g., integrated summary of safety (ISS) and integrated summary of efficacy (ISE). - Direct Project Support: Providing direct support to key studies in order to ensure sufficient planning of statistical deliverables from vendors as well as work by in-house statistical programmers. - CRO / Vendor Oversight: Manages higher-level negotiations and provides oversight of budget, resources, and timelines for contract research organizations (CROs) for multiple projects and ensures timely delivery of high quality deliverables at reasonable cost. Identify/develop tools for efficient vendor management. - Global Health Authority Interaction / Negotiation: Reviews documents and responses submitted to health authorities globally with respect to data standards, compliance, etc. May represents the function at health authority meetings. Reviews and provides input to TLF shells for submission documents (e.g., ISE and ISS). Develops the process for ensuring that analysis data sets and outputs are compliant with regulatory requirements, including CDISC ADaM data set specifications, reviewer's guides, etc. - Global Biostatistics Data Management (BDM) Strategy to Improve Drug Development: Leads implementation of vision and strategy, and identifies technology needs for the function to improve the harmonization and efficiency which leads to cost savings and accelerated worldwide product submissions and approvals. Authors or initiates writing of global standard operating procedures for statistical programming practice, especially with respect to oversight of vendor performance. Oversees compliance with standard procedures and processes. Leads the development and refinement of analysis data standards for AML as well as solid tumor studies. - Leadership of Strategic Initiative and Cross-Functional Collaboration: Provide leadership for strategic and process improvement initiatives within Biostatistics Data Management. Works with colleagues at DST and DSE to identify opportunities for global harmonization and process improvement.Ensure close collaboration with other functional areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs, etc. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Bachelor's Degree an accredited institution in a science or in a technical field preferred - Master's Degree preferred Experience Qualifications - 10 or More Years experience (Bachelor 12 or More Years) in pharmaceutical industry preferred - Thorough understanding and proficiency of CDISC. preferred - Advanced knowledge of CDISC requirements for SDTM and ADaM. preferred - Worked and played major role in electronic NDA and/or BLA submission via eCTD preferred - Working knowledge in statistics as measured by ability to interpret SAPs/shells to generate ADaM and TLFs. preferred - Strong project management experience and ability to manage and execute multiple projects and deadlines. preferred Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Director Statistical Programming

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The primary responsibilities of the Associate Director, Omni-Channel Marketing is to develop, plan and implement the omni-channel marketing strategy to key customer segments across the portfolio in partnership with brand teams. The incumbent should assess external digital opportunities and threats as key inputs to decisions on business strategy given market dynamics. The Associate Director should support smooth execution of all omnichannel platforms, tools and applications, including but not limited to customer 360 database, websites, media, and CRM. The individual will Measure ROI and KPIs and assess need for enhanced investments and innovative platforms. Responsibilities - Support value proposition creation of the Daiichi Sankyo marketed products for customers, by identifying gaps, trends and opportunities for success across all channels. Assess challenges and opportunities and/or organizational dynamics to proactively employ appropriate actions to quickly deploy technologically advanced tools, resources to optimize customer 360 experience and reaffirm brand messaging, positioning and any patient materials (as needed). All digital solutions should augment customer facing roles and allow for further penetration of brand messaging, while driving innovation. Evaluate and recommend new optimization methods to improve customer experience. Generate innovative ideas to increase web traffic and ensure best web practices are being met and brand strategies and identities are maximized. Understand the long-term impact based on market dynamics now and in the future and facilitate strategy and plan implementation to produce long term profitable access, while meeting short term key brand performance metrics. - Work with IT and external vendor partners to manage user experience across platforms, assisting with problem resolution. Partner with brand teams, key sales, operations and market access personnel, as well as other internal stakeholders to ensure digital, financial and strategic optimization. Ensure customer 360 lens is clearly understood by brand leadership, is incorporated into analytics, is compliant and validated. Evaluate and recommend new optimization methods to improve customer experience. Act as a champion and change agent in leading the organizational changes required to create and sustain digital capabilities. Foster productive relationships with key senior customer decision makers. - Manage the day-to-day operations of Omnichannel Marketing for Brand team/s, including all budget-related, project management oversight and other issues. Act as a champion and change agent in leading the organizational changes required to create and sustain digital capabilities. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Bachelor's Degree Marketing, Business Administration, or other related area preferred required - MBA Marketing, Business Administration, or related area preferred Experience Qualifications - 7 or More Years Overall related experience required - 4 or More Years Experience in developing and implementing digital/omnichannel marketing strategies. required - 1 or More Years Pharmaceuticals Experience including Sales, Marketing, IT or Market Access Leadership or other related area. preferred Travel Ability to travel up to 20% Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Associate Director, Omnichannel

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: This role is responsible for all aspects of meeting technology, as well as, building and maintaining relationships with vendors and suppliers. The role will involve implementing and maintaining innovative technology solutions for Meetings and Events, ensure smooth operations, and collaborating with vendors to optimize services and achieve successful outcomes. The role will oversee M&E vendor training programs and initiatives. The role will be crucial to enhancing participant experiences, streamlining processes, and driving excellence in meeting execution. Responsibilities Meeting and Event Technology Strategy - Develop and implement a comprehensive technology strategy for meetings and events, aligning with organizational goals and objectives. - Stay updated with emerging technologies, tools, and trends in the meetings and events industry, evaluate and make recommendations based on organization's needs. - Identify, evaluate and propose opportunities for leveraging technology to enhance attendee engagement, improve operational efficiency, and deliver exceptional meeting experiences. Vendor Relations and Contract Management - Develop and nurture relationships with vendors and suppliers - Identify and evaluate potential vendors, negotiate contracts, and manage vendor selection process - Collaborate with vendors to define and manage service-level agreements (SLAs), ensuring compliance and high-quality service delivery - Monitor vendor performance, conduct regular evaluations, and address any issues or concerns that arise - Stay informed about market trends and new vendor offerings, proactively identify opportunities for partnerships and innovation. Budgeting and Cost Management - Manage budgets for meeting and events technology - Track and control expenses related to technology solutions, and vendor services - Identify and recommend cost-saving opportunities without compromising quality or attendee experience. Vendor Training - Design and deliver comprehensive training program for ME vendor teams, DSI ME team including onboarding, and compliance. Ensure training program aligns with ME objectives, best practices and DSI Compliance. - Create and maintain training materials, including presentations, manuals, e-learning modules, and other resources. Collaborate with subject matter experts and instructional designer to develop engaging and effective training content. - Assess the effectiveness of vendor training programs through evaluations, surveys, and feedback from participants and stakeholders. Analyze training metrics to measure the impact of training and initiative and identify areas for improvement. Continuous Improvement and Innovation - Monitor industry best practices and technological advancements, identifying opportunities for improvement in meeting and event technology. - Gather feedback from stakeholders, participants, and vendors to evaluate effectiveness of technology solutions and identify and implement areas for enhancement. - Lead or contribute to process improvement initiatives, streamlining workflows, and optimizing technology-related processes. - Stay informed about industry certifications, professional development opportunities and training programs to enhance skills and knowledge. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - High School Diploma required - Bachelor's Degree In the absence of a bachelor's degree, 7+ years of pharmaceutical industry experience may be considered to satisfy this requirement preferred Experience Qualifications - 4 or More Years 5+ years in meeting planning or technology project management required - Strong knowledge of Cvent or other meeting management software required - Pharmaceutical industry experience preferred Licenses and Certifications - Certified Project Management Professional (PMP)-PMI preferred Travel Ability to travel up to 10% Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Manager, Meeting Technology and Vendor Relations

Job Identification <ul> <li> Job Title: Senior Specialist, Military Resale - OP Support </li> <li> Area of Responsibility: Operation Support and Distribution </li> <li> Department: Military Resale </li> <li> Reports to: Senior Director Retail </li> <li> Location: Alexandria, VA </li> <li> Grade: 18 </li> <li> FLSA Status: Exempt </li> </ul> Statement of Purpose Provide operational support for all aspects of the Military Resale (MR) Program. Assist with supply chain management, item introductions, sales analysis, and category and product management for the Military Resale Program. Business Communications <ul> <li> Employees in Other Divisions Frequently </li> <li> Supervisory Personnel Frequently </li> <li> NIB Associated Agencies Continually </li> <li> Federal and/or State Government Agencies Occasionally </li> <li> Private Sector Business/Suppliers Frequently </li> </ul> Education An undergraduate degree from a regionally accredited college or university preferred . An equivalent combination of education and experience may also be acceptable. Training and Specialized Knowledge <ul> <li> Strong business and project planning/management skills. </li> <li> Strong MS Office with an emphasis in Excel including Pivot tables and VLOOKUP. </li> <li> Strong leadership, management, and interpersonal skills. </li> <li> High degree of skills for marketing, sales, and product distribution functions. </li> <li> Knowledge of AbilityOne policies, regulations, and requirements is beneficial, but not mandatory. </li> <li> Skilled at working across the organization and the agencies, interfacing with multiple personality types ensuring focus on NIB's business development goals. </li> </ul> Core Competencies <ul> <li> Accountability </li> <li> Communication Skills </li> <li> Ethics/Integrity </li> <li> Customer Care </li> <li> Job Knowledge/Technical Skills </li> <li> Process Improvement </li> </ul> Experience <ul> <li> Minimum six years' experience in marketing, merchandising, product development, distribution, project management, and/or business development, in a marketing-oriented retail environment preferred. </li> <li> Military Resale experience is beneficial but not required. </li> <li> Experience in a fast-paced cross-functional team environment required. </li> </ul> Travel Limited travel Specific Duties and Responsibilities Equipment <ul> <li> Coordinate orders for display equipment (Rack Program) under supervision of the MR Team. </li> <li> Keep broker updated on all equipment shipments. </li> <li> Maintain equipment inventory to service the equipment needs for the MR program. </li> <li> Maintain database for MR freight expenditures and orders. </li> </ul> Operational Support <ul> <li> Maintain SKILCRAFT catalogs for DeCA, AAFES and Nexcom. </li> <li> Manage the AbilityOne addition and deletion process. </li> <li> Maintain blind work year and PCN database. </li> <li> Maintain monthly price lists. </li> <li> Process Vendor Credit Memos, equipment, and freight bills. </li> <li> Maintain current database of product photos and specifications. </li> <li> Assist with ad hoc report requirements for the MR Team. </li> <li> Create a monthly newsletter for the broker. </li> <li> Manage Broker Store Visits. Track all store visit reports. Work with the field representatives to finalize all action item reports in a timely manner. Provide an updated report for all store visits. </li> <li> Maintain current GDS database. </li> <li> Work with Associate Product Manger to finalize SKILCRAFT new item checklist process. </li> <li> Maintain Agency database files. </li> </ul> Distribution (IMP Program) <ul> <li> Coordinate all functions of IMP distribution system. </li> <li> Coordinate all functions of the Produce IMP distribution system. Track orders, payment for orders. Provide shipment tracking, packing slips to produce vendor and sales rep. </li> <li> Work with agency and warehousing system to perform activities necessary to maintain a 97% Fill Rate. </li> <li> Determine and monitor delinquency causes, develop, and track corrective action plans. Track and report on time performance by warehouse and distributors. Maintain a database log to document the occurrence of delinquencies and any corrective action plans. Work with distributor and sales information to generate forecasting data to improve fill rates. </li> <li> Act as liaison between agency, warehouse, and distributors, for all special requirements such as case pack changes, removal of obsolete inventory, handling of returned goods, etc. </li> <li> Create and manage exit-strategy for deleted items to minimize salvage. Track costs associated with write-offs, salvage, dead stock. </li> <li> Manage the startup of new products. Coordinate the distribution aspects and set up inventory levels for each New Product Introduction and communicate with the appropriate parties. Track and monitor inventory levels making changes as required. Track store speed to shelf for all new items. </li> </ul> DeCA MR Program <ul> <li> Process and address issues associated with weekly DeCA reject report. </li> <li> Manage PHQ for new items to ensure files are correct for startup dates and store orderable status. </li> </ul> Product Management IMP Program <ul> <li> Strategically develop a product assortment for the IMP program designed to create future growth and a pipeline of new innovative products. </li> <li> Regularly analyze market conditions to keep abreast of trends including brands, prices, and market share. Conduct a competitive survey of local grocery stores, mass retailers (Wal-Mart, and Target) and Commissaries on a quarterly basis. Provide competitive surveys for all new products under consideration or development. </li> <li> Using Category Management principles, work with IFB Solutions, Winston Salem to provide a plan that existing IMP products must satisfy to remain competitive. </li> <li> Review and analyze all IMP products on a quarterly basis to determine best and bottom sellers, validate need for the item or need for product changes/upgrades to the annual plan. Provide a suggested plan of action for all items not meeting specified market and sales requirements. </li> <li> Work with the agency to increase blind labor in the products provided to the MR program. </li> <li> Update Planograms as needed to reflect product changes. </li> </ul> Military Resale Pricing IMP program <ul> <li> Manage the annual pricing process working through agency price increase requests, while maintaining a competitively priced retail product. </li> </ul> Other duties as assigned. NIB IS AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER NIB is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, or protected Veteran status.

Senior Specialist, Military Resale, Op Support

Job Description This role is accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, company policies and procedures and with quality standards internally and externally. Under the oversight of the CRD(Clinical Research Director) / Director, Clinical Research, the individual is responsible to manage/oversee a team of CTCs(Clinical Trial Coordinator). As line manager the role is critical to continuously develop future talent by providing training, support and mentoring to the CTCs, as well as for interns delegated to the Clinical Operations team based on the Internship program, while properly managing situations of low or non-performance. The role will work across the different country operations roles (e.g. CRM(Clinical Research Manager), CRA(Clinical Research Associate)-Manager, Partners, TA-Head, CRD and Sr.COM) to ensure alignment and development of the country CTC capabilities. The person contributes to CTC capacity/resource planning activities to ensure efficient allocation of resources and work. Responsibilities include, but are not limited to:<ul><li>Has significant impact on how a country can deliver country-specific trial </li><li>commitments and objectives especially during study start-up.</li><li>Ensure and oversee proper on-boarding and off-boarding of employees, compliance to initial and ongoing trainings.</li><li>Train and oversee the CORE competencies, ICH-GCP knowledge, Clinical Research environment etc.</li><li>Assure adherence to GCP guidelines, processes and procedures related to direct reports' activities and performance.</li><li>Ensure direct reports are compliant to the timelines and key business metrics.</li><li>Review and approve timesheets, GTT compliance, expense reports, time-off requests and provide proper oversight of CTC's productivity/utilization.</li><li>Provide input for capacity planning, including reporting of current manpower and forecasting of CTC capacity and needs, to provide efficient use of resources.</li><li>Work with CRDs, TA-Heads, CRMs, CRA-Manager, Sr. COM, CRAs, Partners and </li><li>other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide predictability.</li><li>Interacts with CRMs and sites as needed to resolve operational issues, to</li><li>meet commitments in a timely manner and in coordination with the study</li><li>CRM and CRA.</li><li>Interface with GCTO(Global Clinical Trial Operations) partners on clinical trial execution as assigned; including acts as lead liaison with CTC FSP partners in facilitating coordinated process and country delivery.</li><li>Escalates site performance issues to CRM and CRD/TA-Head.</li><li>People and Resource Management:</li><li>Manages CTC - career development, performance reviews, </li><li>etc., including addressing low performance situations, and taking </li><li>appropriate actions.</li><li>Supports and resolves escalation of issues from CTCs.</li><li>Manages capacity/resource planning activities to ensure efficient allocation</li><li>of resources and work. Manage local conflicts between resource and work.</li><li>Ensures CTC compliance to corporate policies, procedures and quality standards.</li></ul>Skills:<ul><li>Demonstrates proactive leadership and must be able to in/directly influence vendors, external partners and country managers to deliver these commitments within specified timelines with minimal oversight from the line manager. </li><li>Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally. He/she is an independent decision maker with a clear understanding.</li><li>of the pros and cons of each decision and takes ownership of decisions</li><li>Ability to work independently and in a team environment.</li><li>Excellent people management, time management, project management and </li><li>organizational skills.</li><li>History of strong performance and leadership.</li><li>Skills and judgment required to be a good steward/decision maker for the company.</li><li>Fluent in Local Language and business proficient in English (verbal and written).</li><li>Excellent working knowledge of all applicable ICH/GCP regulations and </li><li>Good Documentation Practices and ability to work within these guidelines</li><li>Expertise in and excellent working knowledge of core trial management systems and tools.</li><li>Strong coordination and organizational skills.</li><li>High emotional intelligence.</li><li>Strong leadership skills with proven success in people management</li><li>Excellent interpersonal and communication skills, conflict management</li><li>Demonstrated ability to build relationships and to communicate effectively with internal stakeholders and external partners.</li><li>Fluency in both English and local language.</li><li>Advanced Microsoft Excel skills for the purposes of data analysis</li></ul>Qualification & Experience:<ul><li>Minimum of 5 years experience within Clinical Research, preferred experience in the role of CTC, CRA or similar role.</li><li>Line management experience preferred or at the minimum team leader experience.</li></ul>Educational Requirements: Required:<ul><li>Bachelor's Degree (or comparable) in Business Administration/ Life Science </li></ul>Preferred:<ul><li>Advanced degree, (e.g. BA/BS or higher) with a strong emphasis in science and/or Clinical Research Management/Administration.</li></ul>#MRLGCTO #eligibleforERP 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: $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: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Remote Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 05/28/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/28/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295927

Clinical Trial Coordinator Manager (CTC Manager) - REMOTE

Job Description Our company's Sterile & Specialty Products (SSP) department is a multidisciplinary research group responsible for developing non-oral dosage forms (injections, implants, inhaled, ocular) for small, intermediate, and large molecules from preclinical toxicology studies to commercialization. Driving drug product design from the bench to manufacturing facilities, our teams ensure robust product design and development through deep fundamental understanding and characterization including screening and designing drug product compositions, developing scalable processes, and defining primary packaging / device. During development, we leverage smart experimental design, cutting edge analytical tools, and predictive approaches to inform molecule, formulation, and process selection. We are seeking a motivated engineer / scientist to work collaboratively in a team environment to help solve key challenges in formulation development and manufacturing of parenteral pharmaceutical products. The successful candidate will be a passionate scientist with strong academic fundamentals and a drive to develop new medicines to improve human health. In this role, the individual will be responsible for supporting the formulation development of new biological / chemical entities as part of a matrix team from initial first-in-human formulations to commercialization. The successful candidate must be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. Additional Responsibilities: <ul><li> Develops and applies basic principles and scientific concepts to execute work in a laboratory or pilot plant environment to develop sterile drug products. </li><li> Capable of learning practical laboratory / pilot plant skills and fundamental scientific principles to utilize as part of their daily responsibilities. </li><li> Executes routine experiments and data interpretation with appropriate technical guidance. Operates and troubleshoots equipment and processes. </li><li> Builds capability to support manufacturing operations in GXP environments. </li><li> Can understand overall project timelines to manage prioritization of individual contributor deliverables with appropriate supervision. </li><li> Works well with others in collaborative team environments. </li><li> Takes initiative, motivated to excel, has a strong technical background, has excellent communication and interpersonal skills. </li><li> Builds awareness of relevant new and current technologies to grow as a pharmaceutical scientist. </li></ul> Education Minimum Requirements: <ul><li> B.S. and/or M.S degree in Chemical / Biochemical / Biomedical Engineering, Materials Science, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, or related fields </li></ul> Required Experience and Skills: <ul><li> Strong verbal and written communication skills. </li><li> Strong collaboration skills and experience working in a team environment. </li><li> Ability to learn and apply new scientific principles to execution of daily responsibilities. </li><li> Demonstrated ability to collate and conduct basic data analysis. </li><li> Prior experience with Microsoft Office. </li></ul> Preferred Experience and Skills: <ul><li> Prior experience in a laboratory environment. </li><li> Passion to learn and develop as a pharmaceutical scientist. </li></ul>#eligibleforERP NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $68,400.00 - $107,700.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 06/4/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/04/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295622

Associate Scientist, Sterile and Specialty Products

Job Description Our company's Sterile & Specialty Products (SSP) department is a multidisciplinary research group responsible for developing non-oral dosage forms (injections, implants, inhaled, ocular) for small, intermediate, and large molecules from preclinical toxicology studies to commercialization. Driving drug product design from the bench to manufacturing facilities, our teams ensure robust product design and development through deep fundamental understanding and characterization including screening and designing drug product compositions, developing scalable processes, and defining primary packaging / device. During development, we leverage smart experimental design, cutting edge analytical tools, and predictive approaches to inform molecule, formulation, and process selection. We are seeking a motivated and experienced engineer / scientist to work collaboratively in a team environment to help solve key challenges in formulation development and manufacturing of parenteral pharmaceutical products. The successful candidate will be a passionate scientist with strong academic fundamentals and a drive to develop new medicines to improve human health. In this role, the individual will be responsible for supporting the formulation development of new biological / chemical entities as part of a matrix team from initial first-in-human formulations to commercialization. The successful candidate must be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. Additional Responsibilities: <ul><li> Develops and applies basic principles and scientific concepts to execute work in a laboratory or pilot plant environment to develop sterile drug products. </li><li> Capable of learning practical laboratory / pilot plant skills and fundamental scientific principles to utilize as part of their daily responsibilities. </li><li> Executes routine experiments and data interpretation with appropriate technical guidance. Operates and troubleshoots equipment and processes. </li><li> Builds capability to support manufacturing operations in GXP environments. </li><li> Can understand overall project timelines to manage prioritization of individual contributor deliverables with appropriate supervision. </li><li> Works well with others in collaborative team environments. </li><li> Takes initiative, motivated to excel, has a strong technical background, has excellent communication and interpersonal skills. </li><li> Builds awareness of relevant new and current technologies to grow as a pharmaceutical scientist. </li></ul> Education Minimum Requirements: <ul><li> B.S. degree in Chemical / Biochemical / Biomedical Engineering, Materials Science, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, or related fields plus 3 years of industry experience OR a MS degree with some relevant experience </li></ul> Required Experience and Skills: <ul><li> Strong verbal and written communication skills. </li><li> Strong collaboration skills and experience working in a team environment. </li><li> Ability to learn and apply new scientific principles to execution of daily responsibilities. </li><li> Demonstrated ability to collate and conduct basic data analysis. </li><li> Prior experience with Microsoft Office. </li></ul> Preferred Experience and Skills: <ul><li> Prior experience in a laboratory environment. </li><li> Passion to learn and develop as a pharmaceutical scientist. </li></ul>#eligibleforERP NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $83,100.00 - $130,900.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 06/4/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/04/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295663

Scientist, Sterile and Specialty Products

Job Description Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you! Bio-Technician, Level 1/2 Responsibilities: <ul><li>Following the appropriate SOPs, MPDs and other pertinent documentation, performs all functions required to produce vaccines.</li><li>Maintains production records, physical inventory and accounting reports, instructs and directs assigned personnel; maintains in-process checks and assists in developmental work pertaining to production methods when required. Documents all work according to proper cGMP documentation practices and performs review of manufacturing documentation.</li><li>Performs all work duties via automated systems or manual operations in compliance with safe operating procedures, company and government regulations, and good manufacturing practices.</li><li>Process monitoring documentation and process review will be completed as required to ensure that only the highest quality product is released.</li><li>Cleans, assembles, operates, disassembles, maintains, trouble shoots and initiates corrective actions as required to meet production schedules.</li><li>Trains personnel on approved processes and procedures.</li><li>Dispose of Process waste material as per departmental SOP and regulatory guidelines.</li></ul>Equipment (including, but not limited to):<ul><li>ANALYTICAL EQUIPMENT ( e.g. pH meters, conductivity meters, spectrophotometer, pipettes, off-gas analyzer and Biolyzer)</li><li>AUTOMATED SYSTEMS (e.g. DCS, robotics)</li><li>CIP SYSTEMS (automated and manual)</li><li>CLEANING EQUIPMENT AND SUPPLIES (e.g. mops and disinfectants)</li><li>DECONTAMINATION EQUIPMENT (e.g. autoclaves and tanks)</li><li>IDENTIFICATION SYSTEMS (e.g. labeling devices)</li><li>MAINTENANCE EQUIPMENT (e.g. tools and calibration equipment)</li><li>MATERIAL HANDLING EQUIPMENT (e.g. hand jacks, carts, hand trucks, hoists, biosafety cabinets, chemical fume hoods, freezers, thaw baths and pumps)</li><li>PROCESS VESSELS (e.g. tanks, fermentors, portable banks, bags and bottles)</li><li>SEPARATION SYSTEMS (e.g. filters, centrifuges, and chromatography equipment)</li><li>WEIGHMENT SYSTEMS (e.g. scales, balances)</li><li>ENVIRONMENTAL MONITORING EQUIPMENT (e.g. SMA, particle counters)</li><li>COMPUTER SYSTEMS (e.g. IMPACT, NGL, HanDEL)</li><li>SPECIAL LABORATORY EQUIPMENT (e.g. microscopes, centrifuge, pumps)</li></ul>Duties:<ul><li>Working in conjunction with all appropriate personnel, performs manual and automated</li><li>operations, general maintenance and support functions necessary for the production of vaccines.</li><li>Participates in and assists with the development and execution of personnel training.</li><li>Revises and authors SOPs and GMP documentation.</li><li>Serves on safety, quality and other committees as required.</li><li>Provides all documentation and clerical functions necessary to allow proper accountability and traceability of product.</li><li>Maintains, inventories, and transports all required equipment, materials, supplies and products. Ensures shipment criteria and timely availability and delivery.</li><li>Demonstrates proficiency with Distributed Control System and other automated systems (including, but not limited to, NGL, WATS, HanDEL, Word, Excel, and IMP ACT)..</li><li>Performs general maintenance and assists in troubleshooting of equipment.</li><li>Performs housekeeping in all work areas. Executes facility decontamination according to approved procedures.</li><li>Performs sampling/in-process testing supporting the manufacturing and validation processes for current process as well as developmental work for new products/processes as required..</li><li>At the start and finish of each shift, reports and makes recommendations regarding equipment supplies, required repairs, process concerns, safety concerns, and area for improvements.</li><li>Immediately notifies the appropriate personnel of compliance, environmental, safety, and process deviations.</li><li>Maintains, cleans and prepares equipment used in vaccine production.</li><li>Schedules and performs environmental monitoring during processing and records results in the computerized database system.</li><li>Performs all job functions of Support Associate or Clerk positions as required.</li><li>Delivers all samples and other materials as required to appropriate laboratories.</li><li>Attends and actively participates in HAZOPS, waste walkthroughs, kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives as required.</li></ul>Level I employees will be systematically trained in the following skills. Once proficiency has been demonstrated in a skill, employees will be responsible for performing these skills as required. Demonstrated proficiency in ALL skills is required for promotion to Level 2. <ul><li>Process operations, in process testing, and in process maintenance/system checks</li><li>Document Review and basic math skills</li><li>Utilization of material and financial system (eg. IMPACT)</li><li>Utilization of automated systems ( e.g. NGL, HanDEL, WATS)</li><li>Utilization oflaboratory and manufacturing equipment</li><li>Environmental Monitoring (including: scheduling, sampling, and data review)</li><li>Inventory management and stocking Housekeeping and cleaning</li><li>Safety and cGMPs including involvement in systems to maintain and improve compliance</li></ul>Education:<ul><li>Minimum bachelor's degree in chemistry, biology, biochemistry, microbiology, molecular biology or life sciences, chemical, biochemical engineering or other relevant science/engineering program.</li><li>Passing Sills Assessment Test.</li></ul>Experience:<ul><li>NECESSARY: Individual must successfully demonstrate and maintain proficiency in aseptic techniques and aseptic gowning by passing monitoring testing. Individual must continue to progress towards attaining a Level 2 position by completing training on required skills.</li><li>DESIRABLE: Previous laboratory or manufacturing operations experience requiring aseptic or sterile technique. Previous experience working in a GMP facility. Previous automated system or computer experience preferable.</li></ul>Equipment or machinery operated:<ul><li>Automated systems such as Distributed Control System (DCS) an automated process control system that governs the operation of most equipment. POMS, LIMS and IMPACT.</li><li>Analytical, monitoring, and laboratory/manufacturing equipment, including but not limited to: centrifuge equipment, spectrophotometers, pH and conductivity meters, scales, balances, filtration equipment, chromatography columns, off-gas analyzer, pumps and sampling assemblies, refrigerators, and CTUs.</li><li>Process vessels such as fixed and portable tanks, fermentors, bags and bottles.</li><li>Safety: personal protective equipment such as respirators, hearing protection, and other personal protective clothing. Biosafety cabinets and chemical fume hoods.</li><li>Material handling equipment such as drum lift, hand jacks, carts, hoists and pumps.</li><li>Decontamination and cleaning equipment such as autoclaves, disinfectants and mops.</li></ul>Special Skills or Abilities:<ul><li>Ability to perform aseptic/sterile operations. Mechanical aptitude and ability to analyze equipment and take appropriate corrective action.</li></ul>NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: 2nd - Evening, 3rd - Night Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 05/30/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/30/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R296627

Biotechnician Level 1/2

Job Description Duties and Responsibilities (including but not limited to): <ul><li>Helps to train new personnel</li><li>Ensures compliance with Generally Accepted Accounting Procedures, Sarbanes Oxley Act, internal and external accounting guidance and our company's standard operating procedures.</li><li>Responsible for the creation of Grants in our Grant Management System or Purchase Orders in SAP for Consultant or Vendor Agreements and maintaining all purchase orders or grants</li><li>Responsible for the creation of PPR payments in SAP for Ex-US consultant payments</li><li>Processing, tracking and approving monthly invoices in our Grant Management System</li><li>Reconciling grants or purchase orders</li><li>Resolving invoice issues for the vendors and consultants</li><li>Consulting with Global Clinical Trial Operations, Finance and Procurement on vendor or consultant contracts</li><li>Summarize Purchase Order/ Agreement justification for our Research & Development Division's Senior Management</li><li>Corporate Audit Support</li><li>Assures our company's Grant of Authority policies are followed</li></ul> Qualifications, Skills & Experience: <ul><li>High School degree required</li><li>Bachelor's degree preferred</li><li>3+ years in Accounting/Finance related position</li><li>Must have SAP experience</li><li>Excellent written and oral communication skills</li><li>Strong interpersonal skills</li><li>Knowledge of Microsoft Office applications especially Excel</li><li>Good interpersonal skills demonstrated as energetic, proactive, enthusiastic, and independent thinker</li><li>Excellent organizational and analytical skills</li><li>Ability to handle multiple priorities within matrix environment</li><li>Works and meets deadlines with minimal supervision</li><li>Demonstrated effectiveness working independently, collaboratively with peers and in cross-functional teams</li></ul>MSJR #EligibleforERP 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: $68,400.00 - $107,700.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Remote Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 05/28/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/28/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295289

Payment Coordinator (Remote)

Job Description The Clinical Specialist position is a combined position of clinical scientist and study management duties supporting one or more clinical trials. Under the oversight of a clinical scientist, study manager, or program lead, the Clinical Specialist may be responsible for but not limited to: Job Responsibilities<ul><li>Maintain clinical trial files (including eTMF), project processes, tracking systems, and other utilized study or departmental systems</li><li>Generating and reviewing medical monitoring reports</li><li>Creating and maintaining project schedules</li><li>Distributing, reconciling, and archiving clinical documents</li><li>Tracking and reconciling labs/sam es</li><li>May interact with internal and external stakeholders (e.g., study sites, committees) in support of clinical trial objectives</li></ul>Core Skills<ul><li>Pharmaceutical, research, medical, and/or clinical drug development knowledge/experience</li><li>Strong communication, writing, and presentation skills</li><li>Effective time management and organizational skills</li><li>Ability to effectively work in a team environment and independently</li><li>Proficient knowledge in Microsoft office or similar (Excel, PowerPoint, Word, Outlook, etc.)</li><li>Preferred: knowledge of GCP, project management, process improvement, data analytics</li></ul>Education/Experience<ul><li>Bachelor's Degree +1 years of pharmaceutical, clinical drug development, project management, and/or medical field experience</li><li>OR Master's Degree Degree in life sciences, preferred.</li></ul>NOTICEFORINTERNALAPPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. MRLGCTO CSSMHiring CSSMGenMed #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: $68,400.00 - $107,700.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 05/25/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/25/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295750

Associate Scientist, Clinical Specialist

Job Description Position Description: Technician, Operations 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. Position Qualifications: 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 Job Posting End Date: 06/4/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/04/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R296205

Technician, Operations

Job Requirements We are excited to be a sponsor of SkillBridge and proud to offer transitioning service members a unique opportunity to gain valuable professional experience with our Company. With our generous military-friendly policies, we've received accolades from several organizations such as GI Jobs, Military Times EDGE, and Employer Support of the Guard and Reserve (ESGR). Consider a future with us and discover an employer who will foster your best work as you continue to strive for the well-being of others. Who we are ... We are known as Merck & Co., Inc., in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What we look for ... Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your integrity, knowledge, imagination, skill, and teamwork to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today. Overview: Pharmacy Vaccine Account Representative SkillBridge Intern Description: Our Hybrid Sales team support our customers by providing clinical information about products, educational information, clinical training programs and resources. We support healthcare providers and healthcare systems in meeting the healthcare goals of the patients in their communities. The Pharmacy Vaccine Account Representative SkillBridge Intern (PVARSI) is a member of the Vaccine Account Team and supports the Company's Vaccines customer engagement model. The first portion of the SkillBridge Internship, the PVARSI will be trained to our company's standard of excellence in sales. Following upskilling and job training, the PVARSI will be responsible for engaging with assigned customers (i.e., pharmacy, medical groups, physician offices) in a way that supports the local market and focuses on population health and centers on the highest potential business opportunities with these customers that will improve our impact on public health. They will work with the local market team to understand and identify customer needs, proactively align products and services, support pull-through activities relative to integrated strategies, and ensure that our Company is viewed as demonstrating value and better health outcomes to healthcare professionals and their patients. The PVARSI is responsible for ensuring all activities adhere to the spirit and letter of all Company Policies and US Laws and Regulations. The PVARSI reports to the Customer Team Leader (CTL), Vaccine Customer Center, and works in close collaboration with broader Vaccine Field Sales team. <ul><li>This position is a hybrid sales position with 70% of the engagements with HCPs occurring remotely </li><li>The hours for the internship are 8 hours per day between 8AM - 7PM EST, Monday - Friday, adjusting hours aligned to the geographical time zone based on residence.</li><li>Our Team provides vaccine information and support to customers across time zones, as a result job hours vary depending on territory assignments. </li></ul>Position Responsibilities: Account Management & Contracting <ul><li>Understand multiple interdependencies within an account, consider customer healthcare goals and needs, and maximize account performance by building long-term relationships through collaborative business planning processes and approaches. This includes conducting customer business reviews with appropriate stakeholders discussing the financial impact of contracts and progress/ results of targeted vaccine programs and previously identified opportunities to improve customer benefits. </li><li>Maintain complete knowledge and understanding of our company's contract terms and conditions. Apply knowledge of contracts and historical ordering patterns to optimize vaccine purchases for customers and appropriate inventory in support of office protocols, vaccination goals, and seasonality in patient origination. </li><li>Establish and track account performance metrics to evaluate progress and performance, and to assess opportunity and need to adjust plans and associated tasks. </li><li>Apply knowledge of full portfolio of our company's vaccines, competitive brands, immunization recommendations and protocols to support the integration of a standard of care and the development and establishment of vaccination protocols. </li><li>Manage customer supply, product transition, and back-order challenges and communications. </li></ul>Sales Acumen <ul><li>Build trust with customers and demonstrate value in selling situations to deliver high-quality engagements or interactions that deliver products/ solutions with the common goal of improving health outcomes in pediatric, adolescent, and adult populations and across diverse customer segments. Work cross functionally with each Field Sales counterpart to provide support and resources that assist customers in achieving health outcomes. </li><li>Collaborate with customers through solid relationship management skills and leverage customer insights to provide appropriate information and solutions. </li><li>Change customer behaviors by understanding beliefs and experiences and providing appropriate insight that creates a different experience. </li><li>Create a compelling and logical rationale for the value of Company Vaccines (clinical) and Commercial Offers in support of patient health & wellness. </li><li>Ask strategic, insightful questions to obtain information on customer healthcare needs, use the insights to position Company vaccines and commercial offers. </li></ul>Customer Segmentation & Targeting <ul><li>Divide assigned customer population into groups of individuals who share similar characteristics and buying behaviors, and apply this information to focus on groups effectively, allocate promotional resources, and drive execution of commercial plans. </li><li>Evaluate and prioritize business across assigned customer segments. </li><li>Apply customer insights to effectively and differentially allocate marketing and field resources that drive execution of sales and marketing plans. </li><li>Communicate our Company's Vaccine clinical information and Commercial Offers in a way that is meaningful and relevant to each individual customer; customize discussions and client interactions based on understanding of customer's needs. </li></ul>Work Experience Requirement: Transitioning Service Member who is eligible for participation in the DOD SkillBridge program. Position Qualifications: Education: <ul><li>S1 - Bachelor's degree with 0-3 years Sales experience OR a minimum of high school diploma with at least 4 years of relevant work experience which could include: professional sales, experience in marketing, military, or healthcare/scientific field (pharmaceutical, biotech, or medical devices). </li><li>S2 - Bachelor's degree with 3 (36 months) or more years Sales experience OR a minimum of high school diploma with at least 6 years of equivalent experience which could include professional sales, experience in marketing, military or healthcare/scientific field that is not sales related (pharmaceutical, biotech, or medical devices). </li></ul>Preferred Experience and Skills: <ul><li>Primary Work Site/Schedule: Mon-Fri (first shift) </li></ul>Requisition ID:P-100826

Pharmacy Vaccine Account Representative - Military Skillbridge Opportunity (Remote)

Job Description Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its legacy for over a century. Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Our company's Animal Health (AH) Division works to improve the health of animals around the world through collaborative partnerships and a deep sense of responsibility towards our customers, consumers, animals, society, and planet. This team of energetic, independent thinkers offers one of the industry's most innovative portfolios of products, services, and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species both domestically and internationally. Our company's Animal Health, Elkhorn, NE is a BioTechnology Center of Excellence that manufactures, fills, packages and distributes vaccines for animals. As a member of the Regulatory Affairs Biologics team, the Senior Specialist is responsible but is not limited to the following duties:<ul><li>Provide USDA regulatory guidance and regulatory strategy with interdepartmental teams for pre and post license of US Biologicals.</li><li>Review, prepare and communicate regulatory submissions in support of new licenses or licensed biologicals with the USDA. Alternatively, may review and prepare registration documents for export markets.</li><li>Review market advertising and promotions for US biologicals in compliance with USDA regulations.</li><li>Prepare and maintain regulatory documents and communications regarding US biological products with local and federal agencies.</li></ul>Education: Minimum Requirements<ul><li>Bachelor's degree with at least 5 years of USDA or FDA regulatory experience, -OR - Master's degree with a minimum of 3 years of USDA or FDA regulatory experience in the vaccine or pharmaceutical industry.</li><li>Knowledge of USDA requirements and regulations relating to manufacturing and research and development of biological vaccines. Excellent time and project management skills. Excellent people, communication and leadership skills for involvement with cross departmental teams.</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: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: Yes Hazardous Material(s): n/a Job Posting End Date: 06/12/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/12/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R292516

Sr. Specialist, Regulatory Affairs

Job Description Biologics Process R&D Scientist Our Research Scientists are our Inventors. Using innovative thinking, state-of-the-art facilities, and robust scientific methodology, we partner to deliver the next medical breakthrough. Biologics Process Research & Development (BPR&D) within our company's Research Laboratories is on a mission to rapidly deliver diverse biotherapeutics to patients by efficiently developing innovative, robust manufacturing processes and technologies. To achieve this, we work closely with colleagues in Discovery, Pre-clinical, Early Development, Analytical, Formulation, and Commercial Manufacturing while providing a diverse and inclusive environment for all. Beyond process development for pipeline biologics, we innovate and build next generation biomanufacturing technologies. Examples include investments for development of continuous manufacturing, green and sustainable processes, and proprietary technology platforms. We actively publish and engage with the scientific community to influence the field. BPR&D includes three lab-facing technical functional areas: Process Cell Sciences (PCS), Upstream Process Development (UPD) and Downstream Process Development & Engineering (DPDE). This job posting covers opportunities for all three functional areas. We are actively looking for highly motivated people with a passion for innovation and interest in contributing to one or more of the three technical functional areas mentioned above. As a Scientist in BPR&D, you will work with immensely creative and collaborative team members to design and develop robust processes in support of early- and late-stage biologics. You will innovate to support our company's biologics pipeline and production platforms through rigorous scientific principles. You will have the opportunity to apply and integrate innovation into biologic process sciences to establish our company as the industry leader in next-generation biologics manufacturing. You may also be expected to contribute to additional areas of interest such as biophysical, reactor, process, economic and/or multivariate modeling as we are committed to leveraging digital ways of working to enhance our ability to design robust processes. Responsibilities include but are not limited to:<ul><li>Develop innovative and disruptive technologies for next-generation biologics manufacturing processes</li><li>Develop and characterize robust clinical processes capable of delivering multi-kilogram quantities of therapeutics</li><li>Design and conduct experiments related to cell-line development, upstream or downstream bioprocessing</li><li>Integrate unit operations with relevant process control and monitoring platforms</li><li>Collaborate across BPR&D, process analytics, and other functional areas in research and manufacturing to advance the biologics pipeline</li><li>Conduct laboratory- and/or pilot-scale studies to support scale-up and technology transfer to manufacturing sites</li><li>Contribute to a safe and compliant laboratory work environment</li></ul> Minimum education required: BS with 2+ years of relevant experience or MS degree (expected graduation by December 2024) in Chemical/Biochemical/Biomedical Engineering, Biotechnology, Biochemistry, Molecular Biology, or related fields with research background in molecular biology, cell culture or protein purification Required experience and skills: <ul><li>Experience with one or more of molecular biology, protein expression, mammalian cell culture, protein purification, biochemical engineering, or analytical technologies</li><li> Scientific understanding of the engineering principles behind recombinant protein production and purification </li><li>Ability to comprehend and execute experiments independently</li><li>Ability to organize, communicate, analyze, and present experimental data to drive conclusions and further study designs</li><li> Knowledge of aseptic technique, protein biophysical properties, and general protein laboratory practices </li><li>Demonstrated ability to independently prepare technical documents and scientific presentations to capture development progress, scientific investigations, and technology development output</li><li>Basic understanding of statistical methods and data analysis tools</li><li> Strong passion and commitment to integrate science and innovation into biologic process development </li><li>Ability to excel in a collaborative and matrix environment</li></ul> Preferred experience and skills :<ul><li>Demonstrated capabilities in understanding and operating bioanalytical techniques to characterize microbial or cell culture processes</li><li>Ability to think critically with excellent problem solving and troubleshooting skills</li><li>High throughput screening, automated bioreactor systems, and liquid handlers</li><li>Experience with process transfer to clinical or commercial manufacturing facilities</li><li>Knowledge of process control and workflow automation tools</li><li> Strong foundation in statistical analysis, design of experiments, data science, computational modeling </li></ul>#BPRD #PRD #EligibleforERP #EBRG #vetjobs NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $83,100.00 - $130,900.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic 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 Job Posting End Date: 06/5/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:06/05/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R296125

Scientist, Biologics Process Research & Development

Job Description With support of Sr CRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.<ul><li>Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.</li><li>Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. </li><li>Gains an in-depth understanding of the study protocol and related procedures.</li><li>Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.</li><li>Participates & provides inputs on site selection and validation activities.</li><li>Performs remote and on-site monitoring & oversight activities using various tools to ensure:</li></ul>o Data generated at site are complete, accurate and unbiased o Subjects' right, safety and well-being are protected<ul><li>Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. </li><li>Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.</li><li>Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.</li><li>Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed. </li><li>Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites</li><li>Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.</li><li>Supports audit/inspection activities as needed.</li><li>Performs co-monitoring where appropriate.</li></ul>Extent of Travel Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling 2-3 days/week. Current driver's license preferred. Qualifications, Skills & Experience: Competency Expectations: <ul><li>Fluent in Local Languages and English (verbal and written) and excellent </li><li>Communication skills, including the ability to understand technical information. Developing ability to present technical information with support.</li><li>Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines. </li><li>Good understanding of Global, Country/Regional CRA Guidelines and ability to work within these guidelines. </li><li>Hands on knowledge of Good Documentation Practices </li><li>Developing skills in Site Management including management of site performance and patient recruitment</li><li>Developing level of monitoring skill and independent professional judgment.</li><li>Good IT skills (Use of MS office, use of some clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.</li><li>Works with high quality and compliance mindset.</li><li>Capable of managing complex issues, solution-oriented approach.</li><li>Ability to perform root cause analysis and implement preventative and corrective action.</li></ul> Behavioral Competency Expectations: <ul><li>Effective time management, organizational and interpersonal skills, conflict management</li><li>Able to work with other experienced research professions to develop skills across multiple protocols, sites and therapy areas.</li><li>High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment, with support from Line Manager.</li><li>Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.</li><li>Demonstrates commitment to Customer focus.</li><li>Positive mindset, growth mindset, capable of working independently and being self-driven.</li><li>Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.</li></ul> Minimum education required: B.A./B.S. required with strong emphasis in science and/or biology. Min. 2 years of clinical research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC or similar. #MRLGCTO #eligibleforERP #ETJOBS NOTICE FOR INTERNAL APPLICANTS In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected salary range: $75,400.00 - $118,700.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here . Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 50% Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: Yes Hazardous Material(s): n/a Job Posting End Date: 05/28/2024 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Job Posting End Date:05/28/2024 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R295712

Candidate sign up

Employer sign up

Blog