- J&J Family of Companies (Titusville, NJ)
- Associate Director , Global Labeling Product Leader - 2406187352W **Description** Johnson & Johnson Innovative Medicine is recruiting for an Associate ... + Lead the development, revision, review, agreement, and maintenance of primary labeling (the Company Core Data Sheet (CCDS), United States Package Insert (USPI)… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Labeling Lead where you will be responsible ... international standards and guidelines. You will provide strategic and tactical labeling expertise to teams while ensuring compliance with applicable regulatory… more
- Ascendis Pharma (Princeton, NJ)
- The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for labeling activities across programs and stages of development, with ... States and the Americas and supporting global needs as required. The RA Associate Director , Labeling will be overall responsible for ensuring compliance with… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune 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...hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs** + Location: Cambridge, MA or Bridgewater, NJ **About the job** The ... Associate Director , US Advertising and Promotion serves...review committee (RC) by providing regulatory guidance on promotional labeling and advertising materials. + Develop solutions to complex… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs** + Location: Bridgewater, NJ or Cambridge, MA **About the job** The ... Associate Director , US Advertising and Promotion serves...AdPromo input to the development of optimal FDA product labeling on original and supplemental New Drug Applications and/or… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , PV Sciences Pleasanton, CA, USA * Princeton, NJ, USA Req #361 Monday, April 22, 2024 Looking for a chance to make a meaningful difference in ... on a transformative journey with Taiho Oncology as an Associate Director in PV Sciences. At the...Investigator Brochures, clinical summary of the NDA/MAA and product labeling and other applicable documents for clinical trials. +… more
- Bristol Myers Squibb (Princeton, NJ)
- … of US Medical Oncology, Genitourinary (GU). The primary responsibility of this Associate Director is conducting strategic review of promotional materials and ... and objectives with the GU tumor portfolio. As a promotional review lead, this Associate Director role is a strategic partner who is solution oriented and… more
- Novo Nordisk (Princeton, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions + Provide… more
- Merck (North Wales, PA)
- **Job Description** **Position Description:** ** Associate Director , Regulatory Affairs Liaison- Vaccines and Infectious Disease** The Regulatory Affairs ... Headquarters Associate Principal Scientist supports products in the Vaccine and...as needed to colleagues in Regulatory Operations, Clinical Safety, Labeling , Regulatory Chemistry, Manufacturing and Control (CMC) as well… more
- Bristol Myers Squibb (Trenton, NJ)
- …or GRL as needed + Provide strategic direction (and content input) on US Labeling + Anticipate and interpret key trends and changes in the global/US regulatory ... environment and provide strategic guidance regarding development plans as a result. + Foster positive relationships with FDA. + Build and maintain a strong, collaborative relationship with all key stakeholders including Commercial, Medical Affairs, Promotion &… more
- Merck (West Point, PA)
- …cross functional projects as appropriate. Relevant projects may include Serialization, Labeling , Research Labs Hana S4 implementation, etc. + Influencing individuals ... across a global matrixed organization (NA, EU, Asia- Pac and LA) to realize the above objectives. + Communicating risks, issues, challenges and technical design and build status/progress. Ensuring issues and risks are tracked and mitigation plans are in place.… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …Affairs. Direct reports include Director of Field Medical Excellence, Associate Director Global Medical Information and direct reports, Senior Manager ... Job Title Senior Director , Medical Information and Field Excellence Requisition JR000014200 Senior Director , Medical Information and Field Excellence (Open)… more
- Merck (North Wales, PA)
- …**Primary activities include, but are not limited to:** + Reports to Executive Director or Associate Vice President, Therapeutic Area Lead. + Develops worldwide ... to the world. **Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:** + Developing regulatory strategy for… more
- J&J Family of Companies (Skillman, NJ)
- …recruiting for: **Senior Associate , Regulatory Affairs** This position reports into Associate Director , Regulatory Affairs and is based Skillman, NJ, USA. ... yours. Watch us here (https://www.youtube.com/watch?v=nV\_CTZI50DI) . **Role reports to:** Associate Director , Regulatory Affairs **Location:** Skillman, NJ… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director of Comparator Strategy and Operations is responsible for managing clinical comparator & ancillary supply and sourcing strategies at the ... program, and study levels for Regeneron clinical trials. The associate director will be part of a...Sourcing from low-cost markets + Pooled supplies + JIT labeling + On-demand procurement + Knowledge of regulatory guidelines… more
- Novo Nordisk (Plainsboro, NJ)
- …The Position Manage and oversee all assigned projects/products/processes. Assist the Director / Associate Director in assuring Novo Nordisk compliance ... regulatory agencies. Supervise designated personnel. Relationships Report to the Director / Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …working within established timelines of investigational product manufacturing, labeling , release, distribution and return/destruction, and/or helping to establish ... of RFP, assumptions and SOW for CROs and IP services vendors ( labeling , packaging, distribution; IVRS/IWRS) + Provides input, reviews, and approves vendor study… more
- Integra LifeSciences (Princeton, NJ)
- …to help improve outcomes. **SUPERVISION RECEIVED** Under direct supervision of Associate Director , Global Marketing - Surgical Reconstruction, TT **SUPERVISION ... product line extensions and/or line trimming, forecasting, pricing strategies, labeling revisions, clinical studies, manufacturing and customer service/operations support… more