- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Tris Pharma (Monmouth Junction, NJ)
- …Director / Director , Procurement. Title and salary commensurate with experience. The Director / Senior Director , Procurement is responsible for multiple ... and assurance of compliance with GxP and other company and regulatory agency procurement policies and procedures throughout the organization. Ensures compliance… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for the global ... regulatory strategies to ensure effective achievement of regulatory /business objectives. The Executive Director will direct...on the project team throughout the product lifecycle. Provide senior staff advice and guidance on regulatory … more
- Repligen (Waltham, MA)
- …global public company is looking for a strong, experienced, and technically sound Senior Director , Assistant Controller, who will own the Company's accounting ... in accordance with GAAP.Ensure timely and accurate financial reporting to senior management and external stakeholders, including quarterly and annual filings (eg,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required Travel: Ability ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls ... development through commercialization. You will oversee internal and external teams, ensure regulatory compliance, and play a key role in scaling our biologics… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …IT, Ethics and Compliance, Commercial, Patient Services, CMR (Clinical, Medical, Regulatory ), Finance, and Novo Nordisk global colleagues. Externally, this role ... IT teams to ensure a strong data and technology foundation Engage senior leaders to drive strategic technology transformations Physical Requirements 10-20% overnight… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the ... position requires strong knowledge about RBQM, and related processes, policies, regulatory requirements and ICH guidance. This position requires excellent project… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …but not limited to - Commercial, Patient Services, CMR (Clinical, Medical, Regulatory ), Finance, and Novo Nordisk global colleagues, to deliver data-driven insights ... and rotations.Demonstrate analytics' value in solving complex business challenges.Engage senior leaders to drive strategic analytics transformations.Partner with Data… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole Summary Under the guidance of an Executive Director , has primary responsibility for developing value evidence strategies, and planning/managing ... develops value evidence strategies for in-line and pipeline products. Obtains senior management approval of evidence generation plans. Provides outcomes research… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/Associate Director , has primary responsibility for ... reimbursement and market access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategy and programsIn collaboration… more
- Merck & Co. (Rahway, NJ)
- …as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- strategies ... communicate with stakeholders at various levels, including cross-functional teams, senior management, external vendors, and clinical sites. Strong negotiation,… more
- Merck & Co. (North Wales, PA)
- …role will focus on supporting HPV. Under the guidance of an Executive Director , within the Value and Implementation, Outcomes Research the incumbent has the ... of patient reported outcomes, epidemiological studies and economic modeling.The Director also works closely with Product Development Teams, Franchise Teams,… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for ... The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be... Affairs (GRA) and will report to the Sr. Director , Labeling, Policy and Intelligence. The position may be… more
- Merck & Co. (South San Francisco, CA)
- …leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be an experienced pharmacometrician with a ... and Simulation (M&S) tools in decision making to drive pipeline impact. The Senior Director will take on primary responsibilities for identifying emerging areas… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the roleThe Director , Procurement will be responsible for establishing and managing a strategic ... trends. Stay informed of industry trends, supplier market dynamics, and regulatory changes impacting procurement. About You Bachelor's degree in business, finance,… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Principal Scientist/ Director , Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes ... Outcomes Research, and will support Pneumococcal Vaccines.Under the guidance of a senior leader, this position supports value evidence outcomes research plans and… more
- Merck & Co. (Upper Gwynedd, PA)
- …integrating state-of-the-art technology and applying rigorous scientific and ethical standards.The Senior Director has primary responsibility for the planning ... to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new...to post-licensure). With a focus on late-stage development, the Senior Director will manage the entire cycle… more
- Repligen (Waltham, MA)
- OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham, MA facility which has proven experience in the biotechnology ... including deviation support, root cause analysis, customer complaint management, hosting customer/ regulatory audits and Certificate of Quality generation at an ISO… more
