62 benefits program manager jobs found

Biogen This is a hybrid position that requires in-person workdays at our facilities in Durham, North Carolina. About this role The Senior Principal Analyst, Statistical Programming leads and oversees statistical programming activities of internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components (define.xml and XPTs), and ad hoc analyses. He/She partners with Biostatistics to deliver high quality, submission ready statistical outputs. This person is also responsible for providing input to the Statistical Programming Portfolio Lead (PL) on overall study timelines, monitoring and meeting agreed upon program(s) milestones, escalating issues as needed to their DM counterpart and estimating resources needs. He/She leads a drug program team of statistical programmers to accomplish tasks and communicate issues, as necessary, to...

Biogen This is a remote position that requires the candidate to be located in the United States. About this role The Senior Principal Analyst, Statistical Programming leads and oversees statistical programming activities of internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components (define.xml and XPTs), and ad hoc analyses. He/She partners with Biostatistics to deliver high quality, submission ready statistical outputs. This person is also responsible for providing input to the Statistical Programming Portfolio Lead (PL) on overall study timelines, monitoring and meeting agreed upon program(s) milestones, escalating issues as needed to their DM counterpart and estimating resources needs. He/She leads a drug program team of statistical programmers to accomplish tasks and communicate issues, as necessary, to senior management....

Biogen About This Role The Director of SABR Submissions Sciences is responsible for leading Global Delivery Management (GDM) function: This role is globally accountable for the operational leadership of GDM function. GDM function delivers timely and quality submissions to global regulatory authorities for both major submissions and Lifecycle management. This role provides strategic leadership, optimizes resource allocation, develops initiatives, and drives operational excellence for entire GDM function. Cross functional collaboration and building trusted relationships (with Regulatory, Reg CMC, Portfolio Management etc) Leads the planning, preparation, and submission of regulatory documents (e.g., eCTD, IND, NDA) to health authorities, ensuring compliance and strategic alignment. Determines Submission Sciences support model and resource allocation. Supports IT initiatives including acquisitions, divestitures, software upgrades, and new software solutions Develop and...

Biogen This onsite, 1st shift role runs Monday to Friday, with some weekend and off-shift support as needed About This Role We are seeking a highly experienced and motivated Biochemistry Senior Associate II to join the Biochemistry team at our RTP biologics drug substance manufacturing facility. The role will support advancing biochemistry laboratory activities, including method execution, troubleshooting, instrument validation, data interpretation, and participation in project teams. This role primarily works independently with minimal supervision as needed, consults with management on key decisions. What You'll Do Act as the primary team lead and represent the team in absence of Manager Conduct laboratory investigations (i.e. invalids, OOS, and atypical) and deviations Reviews tests, approves release data, and issues certificates Authors and review protocols, change control requests, and SOPs Serve as a technical resource for the workgroup or project...

Biogen About This Role PV Scientists are responsible for assigned tasks for designated products or product groups. Reporting to a Sr. PV Scientist or above, the PV Scientist will serve either as a lead PV Scientist or supporting PV Scientist, depending on his/her assigned product or product groups. Irrespective, the PV Scientist is a critical team member whose responsibilities include performing signal management activities, authoring safety evaluations, contributing to aggregate report planning / authoring, responding to ad hoc regulatory responses, conducting safety literature reviews, and serving on clinical trial safety teams. The PV Scientist, with oversight from their manager, will serve as a Subject Matter Expert for the Global Safety and cross-functional team on relevant global safety regulations and guidelines, data output and analyses, and product information. This position is Hybrid based out of our Cambridge, MA office What You'll Do Collaborates on the...

Biogen As the Pharmacovigilance Agreement (PVA) Senior Manager, you collaborate with varied levels of cross-functional internal and external global stakeholders in all aspects of timely execution and maintenance of safety data exchange agreements (SDEAs) and pharmacovigilance agreements (PVAs) with Corporate Partners. The PVA Senior Manager is integral to the planning, visualization, and archival systems required for on-time development and marketed product SDEAs, PV transfer agreements, and for inspection readiness. This individual contributor role reports to the Head of PV Alliance Management (PVAM) and contributes directly to Biogen's product pipeline and portfolio. What You'll Do Conduct timely outreach for SDEA planning, authoring and stakeholder and corporate partner transparency Manage the SDEA tracker and produce accurate SDEA planning reports and other required status reports Act as an SDEA subject matter expert for audit and inspections and SDEA inbox...

Biogen About this role The Senior Analyst, Statistical Programming leads and oversees statistical programming activities both internally and externally through vendors in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components, and ad hoc analyses. You will partner with Biostatistics to deliver high quality, submission ready statistical outputs with some supervisions. You are responsible for providing input to the Portfolio Lead (PL) on overall study timeline, monitoring and meeting agreed upon study milestones, escalating issues as needed to their PL counterpart and estimating resources needs.You will lead a study team of statistical programmers to accomplish tasks and communicate issues, as necessary, to line management. This includes communication and quality oversight of the vendor. You will represent the Statistical Programming perspective to the study team and is...

PhRMA Overview Pharmaceutical Research and Manufacturers of America (PhRMA) is seeking a Director of State Policy for the State Advocacy team. The Director will play a pivotal role in shaping policies that protect and promote the discovery, development, and delivery of medicines to help patients live longer and healthier lives. Reporting to the Deputy Vice President, you will develop and lead the policy-related strategy for key midwestern states, including Ohio, Indiana, and Kentucky. You’ll have the resources and support you need to be effective on key issues, including Medicaid, insurance, cost/value, 340B, and prescription drug pricing. In this highly visible, fast-paced role, you will collaborate with colleagues across PhRMA, engage with stakeholders at more than 30 member companies, and represent PhRMA at state legislative and regulatory hearings and other stakeholder meetings. You’ll apply your expertise in relationship building and communication to inspire confidence...

Biogen This position is on site at our Research Triangle Park, NC facility, and would include 20-30% travel, domestic and internationally About This Role The Senior Manager reports to the Global VTR Leader and is responsible for leading the VTR Biochemistry team at our biologics site, focusing on strategy, operations, and cross-functional alignment, overseeing analytical method development, optimization, validation, transfer, registration, investigation, and lifecycle management for late stage clinical and commercial products at internal/external sites and contract labs. The Senior Manager will prepare and review regulatory filings and respond to health agency requests (RtQs) using a risk-based approach. The senior manager also manages project prioritization, timelines, resources, and budgets and ensures compliance with global analytical strategies, CAPA, change control, deviations, and quality standards (GMP). The senior manager approves reports, analyzes data, and...

Collegium Pharmaceutical Collegium Pharmaceutical is building a leading, diversified biopharmaceutical company committed to improving the lives of people living with serious medical conditions. We have a leading portfolio of responsible pain management and neuropsychiatry medications. Hybrid: Required to be onsite in Stoughton, MA on Tuesday, Wednesday and Thursday. POSITION OVERVIEW The Manager, Internal Communications will help inform, engage, and inspire employees across the organization. This role is responsible for day-to-day internal communications strategy and execution, including ownership of the company intranet, cross-functional messaging, employee engagement moments, and select executive communications support. The ideal candidate is a strong writer and project manager who enjoys building structure, partnering with HR and business leaders, and creating content that brings our culture and strategy to life. RESPONSIBILITIES Internal Channels & Content *...

Biogen About This Role: As the Senior Manager of Value Evidence Strategy, you will be integral to designing and executing evidence-generation activities that support both global and regional market access objectives. Positioned within the Global Value & Access Team, you will manage specific research projects focused on real-world evidence, patient-reported outcomes, and health economic modeling. This role requires close collaboration with cross-functional partners, including Market Access, Medical Affairs, Clinical Development, and Epidemiology, to translate evidence into compelling value narratives for stakeholders. Reporting to the Head of Value Evidence Strategy, you'll play a crucial role in coordinating workstreams across sub-functions and leading collaborative efforts with external partners, enhancing our strategic alignment and driving success in market access initiatives. What You'll Do: Lead strategic research projects supporting pipeline product...

Biogen About This Role The Senior Manager, US Forecasting will be an integral part of the Decision sciences- Forecasting Center of Excellence team and will assist in developing and maintaining the forecast models for the US business for Biogen North America Franchises, leveraging both primary and secondary data assets to drive accurate predictions and providing valuable insights for strategic planning and resource allocation across multiple indications. The individual will work cross-functionally to gather inputs for the forecast, socialize outputs, and run sensitivities and ad hoc analyses. The individual will help the business build objective and fact-based forecasts and scenarios that enable the business to make data-driven decisions that maximize shareholder value. The role offers a mix of analytical, strategic, and operational work and the opportunity to collaborate with a wide array of stakeholders at various levels to help drive business success. The individual will...

PhRMA Overview Pharmaceutical Research and Manufacturers of America (PhRMA) is seeking a Director for its Policy and Research team to support policy, as well as legislative and regulatory analysis, for Medicaid and the commercial health insurance market. The individual will be responsible for supporting PhRMA policy development and response to current and emerging public policy issues on coverage and access across the Medicaid and commercial health insurance markets, including state, insurer, and pharmacy benefit manager (PBM) actions. The Director will: Serve as a subject matter expert on public policy matters affecting Medicaid and the commercial health insurance markets with a focus on state, insurer, health plan, and PBM actions. Provide expertise on federal and state policies affecting coverage and access under the Medicaid program, including program eligibility, the Medicaid Drug Rebate Program (MDRP), approaches to management of prescription medicines through...

Biogen About the Role: This application is for a 6-month student role from July - December 2026. Resume review begins in January 2026. You will be an integral member of the Global Media Relations and External Communications team, helping to manage the company's reputation with journalists and top media outlets, global product and pipeline communications, and analyzing public perception and sentiment about the company. In total, you will be part of a 5-person team that sits within the broader 30+ person Global Corporate Affairs department. The department is responsible for positioning Biogen as a leader in innovative science and enhancing the company's reputation with key stakeholders, employees, and patients. As part of this department, you will help support the company's business objectives by communicating and informing Biogen's company value proposition and bringing the brand's promise to life. What You'll Do: As a co-op, you will: Support corporate communication...

Merck Job Description SCIENTIST/ENGINEER - Upstream Vaccines and Advanced Biotechnologies Process R&D Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. Applications are sought for an opportunity in the Vaccine and Advanced Biotechnologies Process R&D department (VaxPRD) , which is part of the our company's Research Labs division. The individual will support our company's discovery & development efforts for Vaccine programs at West Point, PA. Vaccine Process Development Scientist/Engineer Role Summary Vaccines and Advanced Biotechnologies Process R&D (VaxPRD) is responsible for the development and clinical...

Merck Job Description Job Description: The Pharmacokinetics, Dynamics, Metabolism & Bioanalytics (PDMB) department at our company is seeking an accomplished scientific leader to head the Biotransformation (MetID) group within Drug Metabolism & Pharmacokinetics (DMPK). The Biotransformation Lead (Director) will play a pivotal role in guiding our company's discovery and development projects through the lens of drug metabolism, ensuring that metabolite profiles are elucidated and understood to de-risk safety, optimize efficacy, and satisfy regulatory expectations. This position offers the opportunity to lead a talented team and drive scientific excellence in a key discipline within DMPK, contributing directly to the advancement of our company's pipeline. The lead will drive our company's metabolite identification strategy and operations, overseeing a team of scientists responsible for characterizing drug metabolites across the discovery and development pipeline. This...

PhRMA Overview Pharmaceutical Research and Manufacturers of America (PhRMA) is seeking a Deputy Vice President for its Policy and Research team to support PhRMA’s research strategy in support of PhRMA policy positions and analysis on the federal budgetary and economic impacts of U.S. federal and state policy reforms on the market for prescription medicines, including implications for access to care, utilization, spending, coverage, and reimbursement. The individual will report to the Deputy Vice President who oversees the Research Unit, as well as other staff across the organization to support the development of PhRMA policy positions and strategy. Key areas of focus will be to develop and manage research and analysis to shape a policy and regulatory environment that supports a competitive market for prescription medicines, improves patient access to care, and sustains future innovation. This highly visible role requires extensive collaboration across PhRMA and with member...

Merck Job Description Position Summary We are seeking a highly motivated Senior Scientist to join the Biologics Potency team within Cell-Based Sciences (CBS), Analytical Research and Development (AR&D) at our company's Research Laboratories in Rahway, New Jersey. The successful candidate will be responsible for developing, pre-qualifying, assessing robustness, executing, and transferring immunoassays and cell-based potency assays to characterize the biological activity of a range of biologic modalities, including antibodies, multifunctional proteins, peptide therapeutics, antibody-drug conjugates, and novel biologics. A key component of this role is the design and implementation of digital and automation solutions to enhance assay performance, data quality, and operational efficiency. Key Responsibilities Develop, optimize, and troubleshoot cell-based potency assays and immunoassays for biologics. Design and execute pre-qualification and robustness studies...

Merck Job Description The successful candidate will play a pivotal role in shaping the future of our CMC (Chemistry, Manufacturing & Controls) digital and data strategy transformation efforts across our R&D division and Manufacturing divisions. The Scientific Associate Vice President role offers a unique opportunity to influence above project/ function strategy, drive digital adjacencies, and ensure connectivity of our data strategy efforts. Join us to make a significant impact on how we leverage data to define process and analytical method development and future data investments for our entire company pipeline. Primary Responsibilities: Partner with the Development Sciences & Clinical Supplies (DSCS) Digital Technologies Lead and CMC functional leaders to drive the development and execution of comprehensive digital strategies that enhance productivity, enhance end user experience and drive business value. Recommend strategic direction and drive...

Merck Job Description The Small Molecule Analytical Research and Development (SMAR&D) group has an exciting opportunity for a Principal Scientist based in Rahway, NJ. Join us and experience our culture firsthand - one of strong ethics & integrity, diversified experiences, exceptional science and a resounding passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. As a Principal Scientist, you will be part of a team developing innovative analytical methodologies for medicines based on small molecules, peptides, mRNA, oligonucleotides and bioconjugates. Our responsibilities range from early stage up to commercialization for both drug substance and a broad array of oral, sterile and combination products. You will also contribute towards regulatory...