74 product manager jobs found

Merck Job Description The Field Access Manager (FAM) serves as the subject-matter expert on access related issues for healthcare professionals (HCPs) and healthcare organizations (HCOs), and will work cross-functionally with patient support, market access, and field sales to support timely patient access to therapy. The FAM will provide information to providers on access processes, reimbursement issues, and support patient assistance programs, all while ensuring compliance with healthcare regulations. The FAM role is a remote/field-based role that proactively provides approved education to defined accounts within an assigned geography on matters related to access and coverage to facilitate appropriate patient access. The FAM will analyze access issues and act as the local access resource for HCPs and other field force personnel and region management, as permitted by policy. Where appropriate, the FAM will coordinate with the access hub concerning individual patient cases...

Merck Job Description The Field Access Manager (FAM) serves as the subject-matter expert on access related issues for healthcare professionals (HCPs) and healthcare organizations (HCOs), and will work cross-functionally with patient support, market access, and field sales to support timely patient access to therapy. The FAM will provide information to providers on access processes, reimbursement issues, and support patient assistance programs, all while ensuring compliance with healthcare regulations. The FAM role is a remote/field-based role that proactively provides approved education to defined accounts within an assigned geography on matters related to access and coverage to facilitate appropriate patient access. The FAM will analyze access issues and act as the local access resource for HCPs and other field force personnel and region management, as permitted by policy. Where appropriate, the FAM will coordinate with the access hub concerning individual patient cases...

Nuvalent, Inc. The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Associate Director, Clinical Operations, the Manager, Clinical Operations will ensure excellence in clinical trial planning, execution, and data collection, in accordance with regulatory guidelines. They will be responsible for aspects of clinical study conduct, including site selection, study start-up, conduct and close-out. Providing appropriate escalation of trial specific issues to deliver high quality clinical trial results. Able to adapt to changes in the work environment and manage competing demands. Responsibilities: Manage multiple aspects of clinical...

Nuvalent, Inc. The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Associate Director, Clinical Operations, the Manager, Clinical Operations will ensure excellence in clinical trial planning, execution, and data collection, in accordance with regulatory guidelines. They will be responsible for aspects of clinical study conduct, including site selection, study start-up, conduct and close-out. Providing appropriate escalation of trial specific issues to deliver high quality clinical trial results. Able to adapt to changes in the work environment and manage competing demands. Responsibilities: Manage multiple aspects of clinical...

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, Quality Assurance will be responsible for supporting the manufacturing, testing, and release of drug products for clinical and commercial use. They will ensure compliance with all aspects of 21CFR *210, *211, and *820 cGMP. This role will be responsible for providing leadership in the management of critical quality systems (i.e. : Batch Disposition, Investigations (Deviation / Product Complaint), CAPAs, Change Control, etc. ) that allow the company to maintain all licenses to operate. This individual will be critical in supporting interdepartmental and cross functional project...

Nuvalent, Inc. The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Associate Director, Corporate Strategy, the Senior Manager, Competitive Intelligence (CI), will support CI activities across Nuvalent's portfolio. CI is a key function within Nuvalent, and this role is a great opportunity to have broad visibility across the organization. The key focus for this role is driver mutated solid tumors, particularly ALK+, ROS1+, and HER2m NSCLC. The role also includes monitoring of the strategies, programs, and capabilities of competitors in research, development, and promotional areas, as well as overall industry trends. Within this role,...

Nuvalent, Inc. The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Associate Director, Corporate Strategy, the Senior Manager, Competitive Intelligence (CI), will support CI activities across Nuvalent's portfolio. CI is a key function within Nuvalent, and this role is a great opportunity to have broad visibility across the organization. The key focus for this role is driver mutated solid tumors, particularly ALK+, ROS1+, and HER2m NSCLC. The role also includes monitoring of the strategies, programs, and capabilities of competitors in research, development, and promotional areas, as well as overall industry trends. Within this role,...

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: 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...

Nuvalent, Inc. The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Senior Director, Payer & Reimbursement, the Associate Director, Pricing & Contracting Operations plays a critical role in shaping and executing the company's pricing and contracting strategies to optimize access to Nuvalent's product portfolio, as well as playing a key part in driving pricing and contracting strategy and management. We are a growing pharmaceutical company with a commitment to delivering innovative, oral targeted therapies for oncology patients. We are seeking a dynamic and strategic professional to lead pricing and contracting operations....

Nuvalent, Inc. The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Senior Director, Payer & Reimbursement, the Associate Director, Pricing & Contracting Operations plays a critical role in shaping and executing the company's pricing and contracting strategies to optimize access to Nuvalent's product portfolio, as well as playing a key part in driving pricing and contracting strategy and management. We are a growing pharmaceutical company with a commitment to delivering innovative, oral targeted therapies for oncology patients. We are seeking a dynamic and strategic professional to lead pricing and contracting operations....

Merck Job Description This position will be responsible for leading and implementing medical device and combination product design controls for both new products and inline products from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance. This position will interact with cross-functional development teams within and external to Device Development. The incumbent must be able to work well with all levels of employees and be able to effectively coordinate the execution of device development strategies. This individual will be expected to apply his/her knowledge of product development and design control principles to positively support and influence clinical and commercial combination product development and launches to ensure they are developed and manufactured in accordance with regulatory, company, and customer requirements. Principal Responsibilities Lead/contribute to device...

Merck Job Description Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to use innovative thinking, state-of-the-art facilities, and robust scientific methodology, we collaborate to discover the next medical breakthrough. As an Associate Principal Scientist in the multiscale separations team within the Separations Sciences team of Analytical Enabling Capabilities, you will work within a highly collaborative team to enable the advancement of the development pipeline. You will be primarily responsible for chromatographic isolation of pharmaceutical API and impurities from analytical scale to semi-prep scale and prep scale, covering the space of small molecules, peptides, conjugate-based modalities as well as emerging modalities in our portfolio. To accelerate the development of new medicines and vaccines, you will partner with process chemists and analytical scientists...

Merck Job Description We are seeking a highly motivatedsenior level scientist to develop and lead a discovery portfolio focused on neglected tropical diseases (NTDs), with a primary focus on Malaria, TB, and AMR. The successful candidate will shape scientific strategy, drive target and lead identification, and progress innovative therapeutic concepts from early discovery toward development. This role requires strong scientific depth, strategic thinking, and the ability to work effectively in multidisciplinary, matrixed teams. The candidate will also have to work to secure funding through external partnerships. Depending on level and experience, the role will have increasing expectations for scientific leadership, strategic impact, and portfolio ownership. Key Responsibilities: Scientific and Portfolio Leadership Develop and own a coherent neglected tropical diseases (NTDs) discovery strategy aligned with organizational goals, focusing on high-burden diseases...

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...

Merck Job Description Job Description: The Formulation, Laboratory, and Experimentation (FLEx) Center is a multi-modality (small molecule, biologics, vaccine) drug product development and clinical manufacturing facility in Rahway, New Jersey. The Non-Sterile Process Engineering team ensures right-first-time manufacture and delivery of high-quality drug products (spray-dried intermediates, tablets and capsules), leveraging pharmaceutical unit operations such as spray-drying, hot-melt extrusion, blending, roller compaction, encapsulation, compression, and film coating. We are part of our Company's research division, focused on development and clinical deliveries in a GMP pilot facility supporting partners in Oral Formulation Sciences and Pharmaceutical Commercialization Technology to enable faster delivery of new medicines to clinical trials. The Non-Sterile (Oral Solids Dosage) team at the FLEx Center in Rahway is looking for a Sr. Specialist - Process Engineer to lead...

Merck Job Description Position Overview - Basic Functions & Responsibility Essential functions include, but are not limited to: Operational shift team lead, responsible for daily emergency response, safety, and security functions. Provides site-wide fire protection, emergency medical, and hazardous materials response coordination. Conducts scheduled and random inspections of all production, business, and operational support areas for fire, life safety, and security concerns. Daily functions include responsibilities for loss prevention, security, emergency response, project support, facilities, maintenance, and other service areas. Conducts fire and security audits, surveys to test existing controls, and evaluates risks involving protection of tangible and intangible company property. Enforces company regulations concerning security of company property, plant access, traffic control, parking, and employee conduct. Primary Activities The primary...

Merck Job Description Associate Specialist - Process Engineer (P1) Job Description: The Formulation, Laboratory, and Experimentation (FLEx) Center is a multi-modality (small molecule, biologics, vaccine) drug product development and clinical manufacturing facility in Rahway, New Jersey. The Non-Sterile Process Engineering team ensures right-first-time manufacture and delivery of high-quality drug products (spray-dried intermediates, tablets and capsules), leveraging pharmaceutical unit operations such as spray-drying, hot-melt extrusion, blending, roller compaction, encapsulation, compression, and film coating. We are part of our company's research division, focused on development and clinical deliveries in a GMP pilot facility supporting partners in Oral Formulation Sciences and Pharmaceutical Commercialization Technology to enable faster delivery of new medicines to clinical trials. The Non-Sterile (Oral Solids Dosage) team at the FLEx Center in Rahway is...

Merck Job Description Job Description: The Formulation, Laboratory, and Experimentation (FLEx) Center is a multi-modality (small molecule, biologics, vaccine) drug product development and clinical manufacturing facility in Rahway, New Jersey. The Non-Sterile Process Engineering team ensures right-first-time manufacture and delivery of high-quality drug products (spray-dried intermediates, tablets and capsules), leveraging pharmaceutical unit operations such as spray-drying, hot-melt extrusion, blending, roller compaction, encapsulation, compression, and film coating. We are part of our Company's research division, focused on development and clinical deliveries in a GMP pilot facility supporting partners in Oral Formulation Sciences and Pharmaceutical Commercialization Technology to enable faster delivery of new medicines to clinical trials. The Non-Sterile (Oral Solids Dosage) team at the FLEx Center in Rahway is looking for an Associate Director - Process Engineering...

Merck Job Description Scientist, Small Molecule Analytical Research & Development The Small Molecule Analytical Research and Development group has an opening for a Scientist based in Rahway, NJ. Join us and experience our culture first-hand - one of strong ethics & integrity, experiences, exceptional science, and a resounding passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. In your role as Scientist, you will be part of a team of Analytical Chemists working on cross-functional scientific teams to enable novel small molecule, peptide, and oligonucleotide drug development through laboratory-based analytical characterization and statistical data analysis. Primary Responsibilities Support execution of Good Manufacturing Practices (GMP)...