- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare 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
- Merck & Co. (North Wales, PA)
- …brands on select cross-divisional teams Act as the commercial point during labeling meetings and manage label updates Consistently remain current on key insights ... for the brand, customer, and marketplace Qualifications: Required Experience and Skills: BA/BS degree Minimum 4 years Vaccines/Pharma/Biotech experience OR a minimum of 3 years combined strategic marketing, brand management, sales or business support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical protocols, study reports, IBs, INDs, CTAs, IDEs, SRDs, PMAs and labeling for drug and diagnostic products. Provides guidance on planning, writing, review ... of key dossier documents for submissions globally. Ensure high quality collaboration with Clinical Biomarker and Companion Diagnostics team for development of biomarker, companion diagnostic and other device to optimize access to patients.Remains on the… more
- J&J Family of Companies (Titusville, NJ)
- Associate Director , Global Labeling Product Leader (1 of 2) - 2406187352W **Description** Johnson & Johnson Innovative Medicine is recruiting for an ... Associate Director Global Labeling Product Leader (1 of 2) in Raritan, NJ; Titusville, NJ; Horsham, PA; Toronto, Ontario (CA); UK (High Wycombe); Netherlands… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …possible 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 development and implementation of labeling content and strategy of multiple assigned products in various stages of drug development, which may… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …possible 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 development and implementation of labeling content and strategy of assigned product(s) in various stages of drug development, which may include… more
- Bausch Health (Bridgewater, NJ)
- …your skills and values drive our collective progress and impact. The Associate Director , Advertising and Promotion, Prescription Drug Products, reviews, approves ... and monitors prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements. Responsibilities **:** +… 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
- Taiho Oncology (Princeton, NJ)
- Associate Director , PV Sciences Pleasanton, CA, USA * Princeton, NJ, USA Req #361 Friday, June 28, 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
- 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)
- …brands on select cross-divisional teams + Act as the commercial point during labeling meetings and manage label updates + Consistently remain current on key insights ... for the brand, customer, and marketplace **Qualifications:** **Required Experience and Skills:** + BA/BS degree + Minimum 4 years Vaccines/Pharma/Biotech experience **_OR_** a minimum of 3 years combined strategic marketing, brand management, sales or business… more
- Organon & Co. (Plymouth Meeting, PA)
- …the Promotion Review Committee. + Providing day-to-day legal advice to the labeling , quality, supply chain, and regulatory organizations in R&D and Manufacturing. + ... Preparing business clients for regulatory inspections. + Providing legal support for and review of regulatory submissions. + Providing legal advice on issues affecting clinical assets and marketed products. + Providing regulatory legal guidance on a range of… more
- Bristol Myers Squibb (Princeton, 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
- 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
