- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager /Associate Director will be responsible for ... information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director, Labeling, Policy and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Global Service Manager (GSM) focusing on Incident, Problem, and Change is responsible for the ... process improvements and workflow efficiencies. The GSM works closely with QA during regulatory agency, partner, and internal audits and Inspections, and is the IT… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to maximize your potential with us? The Position As the general project manager for Patient Support Solutions, the role focuses on not only leading projects ... team Serve as the Compliance and Legal lead, ensuring adherence to regulatory standards and integrity across all PSS programs. Physical Requirements 0-10% overnight… more
- Novo Nordisk Inc. (Boulder, CO)
- …ensuring the supply of API, during the execution of the job duties, the senior manager should seek to actively support continuous improvement initiatives and ... analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …business on impactful risk mitigation strategies. Relationships Reports to the Senior Director, E&C Business Partner. Works closely with stakeholders within NNI's ... time to understand business goals, strategies, emerging risk areas, and the regulatory landscape, ensuring ability to serve as a knowledgeable and effective… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Senior Project Manager , PMO as part of the Technical Operations team ... project management in cross-functional drug development teams or clinical, regulatory , pharmaceutical sciences/technical operations in the biopharmaceutical industry.Excellent knowledge… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …fields is preferred A minimum of eight (8) years combined pharmaceutical, legal, regulatory , and compliance experience required OR a minimum of six (6) years' ... experience required if accompanied by an advanced degree or certificate (eg MBA, JD, PMP) High standard of ethics and integrity Proven experience managing complex compliance components of business development Understand Business Development lifecycle and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Establish strong and positive working relationship with OPDP reviewers. Report to Senior Director, Regulatory Affairs - Advertising & Promotion. Essential ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership, etc.) on deviations and PQC investigations relating to… more
