- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... safety surveillance sub-function within the US East Coast Development Hub comprised of Senior Global Safety Leads, Global Safety Leads and Senior Global Safety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... research areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC Portfolio Products, will be responsible for regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- J&J Family of Companies (Skillman, NJ)
- Senior Associate , Regulatory Affairs - 2407025090W **Description** Kenvue is currently recruiting for: Senior Associate , Regulatory ... NJ **Travel %:** <10% **Pay: 84k- 152k** **What you will do** The Senior Associate , Regulatory Affairs is responsible for developing regulatory… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... areas centered around rare diseases and immune disorders. **Summary** The Associate Director, RACMC Portfolio Products, will be responsible for regulatory… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Bristol Myers Squibb (Princeton, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . Position Summary : Reporting to the Senior Direc tor , US and Above Market Medical and Market Access C&E ... Lead , this role partners with senior leaders across Legal, Commercial, Medical, R&D, Global Drug...leaders across Legal, Commercial, Medical, R&D, Global Drug Development, Regulatory , IT, Audit, Finance and HR to build and… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be responsible for the ... and alignment of the labeling strategy and labeling content. Interface with Senior Management Cross-Functional Team (GLOC) + In alignment with TAU/MPD Labeling Lead,… more
- Taiho Oncology (Princeton, NJ)
- …such as clinical operations, data management, Pharmacovigilance Operations, Medical Writing and Regulatory Affairs is a plus. + CPM or CPIM certification ... Associate Director, Outsourcing & Vendor Management Pleasanton, CA,...negotiate MSA, SOW/WO, and Change Order. + Meets with senior functional leaders to align with their goals and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …system, including but not limited to: Global Patient Safety (GPS), Medical Affairs , Regulatory , Commercial, etc. + Participate in process improvement activities, ... leading GVP-compliant activities from a quality perspective in conjunction with business and Associate Director / Director, GVP QML + Engage with, support and liaise… more
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Summary:** The Associate Director will be responsible for supporting the development and ... our team members are challenged and engaged with the broader matrix teams. The Associate Director will work with our Brand, Customer Experience, and Finance teams to… more
- Novo Nordisk (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... safety surveillance sub-function within the US East Coast Development Hub comprised of Senior Global Safety Leads, Global Safety Leads and Senior Global Safety… more
- Hackensack Meridian Health (Edison, NJ)
- …+ Minimum of 2 years experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or at least 4 years related experience in the ... compliant study conduct according to all relevant local, federal, and state regulatory and institutional Polices and Standard Operating Procedures. This role carries… more
