- Genmab (Plainsboro, NJ)
- … Affairs, the key responsibilities include but are not limited to: Act as the US/ Global Regulatory Leader (GRL) for assigned project(s) and be responsible ... leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role,...the time per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy, Global … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… more
- Merck & Co. (Rahway, NJ)
- …labeling and obtain shortest time to approval by regulatory agencies.Functions as global regulatory lead assigned to programs where the compound is ... Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory...of all submissions and associated documentation.Provides expertise as the Global Regulatory Lead to Product… more
- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionThe Sr. Director , GMP Quality Assurance will lead the GMP QA strategy and ... release, stability programs, change management, and vendor oversight. The Sr. Director ensures compliance with cGMP standards, oversees QA activities at CDMOs,… more
- Formation Bio (New York, NY)
- …ensures that trials are executed efficiently, on time, and in compliance with all regulatory requirements. The Director will manage a team of Clinical Trial ... degree (eg, MSc, PhD, MBA) in a related field. Preferred: Experience with global clinical trials and regulatory submissions. Formation Bio is headquartered in… more
- Genmab (Plainsboro, NJ)
- …powerhouse. As we expand our direct commercialization efforts, we are seeking a Global Physical Security Director to develop and implement a comprehensive ... security teams to align strategies.Act as the primary liaison with law enforcement and regulatory bodies as needed. Lead and develop a team of internal and… more
- Merck & Co. (Rahway, NJ)
- …pre-submissions, briefing books, IDEs, IVDR PSAs, PMAs.Participate in meetings with global regulatory agencies to provide CDx expertise.Provide CDx input ... Job DescriptionIn this Principal Scientist/ Director position within Translational Oncology, this team member...collaborating with project teams, biomarker leads, clinical operations, and regulatory affairs on the implementation of global … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Clinical Research Director (CRD) is the Clinical Operations lead in a country/cluster and is responsible-for execution of all Clinical Trials ... and project delivery.A complete understanding of ICH GCP and Global /Regional/Local regulatory requirements is-required.-Strong Communication skills requiring… more
- Merck & Co. (Rahway, NJ)
- … regulatory , quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device Development & ... ensure full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key Ofunctions. Lead the Device… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader , a Senior Principal Scientist/Senior Director , has primary responsibility for developing value ... and health systems globally. The ability to participate and lead cross-functional teams is a critical part of this...Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by local subsidiaries in… more
- Merck & Co. (Rahway, NJ)
- …initiatives designed to promote a culture of integrity across our global operations.Key Responsibilities:Conflict of Interest Program Management: Lead the ongoing ... Job DescriptionSummary of PositionThe Global Ethics team actively supports our Company's commitment...Team is seeking a dedicated and experienced individual to lead the Conflict of Interest (COI) program, dedicating 50%… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …culture within our One Development organization. Relationship Reports to the Executive Director Global Medical Affairs East Coast Hub. Will interact with ... a living. Are you ready to make a difference? The Position The Scientific Global Medical Director will provide leadership, direction, and guidance for the… more
- Merck & Co. (Rahway, NJ)
- …and other pharmacometric analyses-Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... Job DescriptionAssociate Director - Pharmacometrics, Quantitative Pharmacology and PharmacometricsThe Quantitative Pharmacology and Pharmacometrics (QP2) department… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to make a difference? The Position The Associate Global Medical Director will serve as a pivotal leader in advancing the mission of our ... culture within our One Development organization. Relationship Reports to the Executive Director Global Medical Affairs East Coast Hub. Will interact with… more
- Genmab (Plainsboro, NJ)
- …and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions ... we would love to have you join us!The Role:The Director acts as a statistical expert supporting the clinical...the clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach resolution.Participate in global ... assigned to alliance assets for operational matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full our ... and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings.-...GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate… more
- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose.The RoleThe Director Global Market Access & Pricing Hematology will be responsible for ... is hybrid based in Princeton NJ (US) and will report to the Senior Director Global Access and Pricing. ResponsibilitiesLead the development of Global … more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.Overview The Global Clinical Trial Manager, Team Manager (GCTM-TM) is responsible for line management ... and strategic support across trials as needed and may assume Global Clinical Trial Manager (GCTM) responsibilities to address fluctuating demands throughout… more
- Merck & Co. (Rahway, NJ)
- …Distinguished Scientist (Executive Director ) and Product Development Team (PDT) lead , Oncology Global Clinical Development, has primary responsibility for ... and in the field of breast cancer. The Executive Director , PDT lead will manage the entire...indication of interest.Work closely with a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory … more
