- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- Drive Labeling Strategy , in-line with overall global regulatory strategy , by providing labeling expertise for Company Core Data Sheet (CCDS), USPI ... negotiation strategies. + Support global HA interaction strategy to discuss key labeling elements. +...facilitate final label negotiations and approval. + Present to Global Labeling Review Team: Ensure Core Data… more
- AbbVie (Florham Park, NJ)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director , Regulatory Affairs Global Regulatory Strategy is ... the obesity/metabolic therapeutic area (TA). This individual leads the Global Regulatory Product Team (GRPT and Labeling ...the Global Regulatory Product Team (GRPT and Labeling Regulatory Strategy Team (LRST). Serves as… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …global clinical supply chain-including forecasting, planning, packaging and labeling operations, IRT/RTSM strategy , distribution, cold-chain management, depot ... Sr. Director , Global Clinical Supply Chain, GCO...Clinical Supply Operations** 1. Oversee forecasting, demand planning, supply strategy , packaging, labeling , and global … more
- J&J Family of Companies (Raritan, NJ)
- …expertly representing market access within Compound Development Team and other global strategy teams, building strong relationships and effective collaboration ... of America, Raritan, New Jersey, United States of America **Job Description:** ** Director , Global Compound Market Access Leader, GU Oncology Early Pipeline… more
- J&J Family of Companies (Raritan, NJ)
- …expertly representing market access within Compound Development Team and other global strategy teams, building strong relationships and effective collaboration ... patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine Global Commercial Strategy Organization, a group within Janssen … more
- Sanofi Group (Morristown, NJ)
- …and setting clear expectations for the device regulatory strategy , including a global labeling strategy + Ensures alignment and communication internally ... **Job title** : Global Regulatory Affairs Device Lead (Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** Are… more
- Bristol Myers Squibb (Princeton, NJ)
- …CI insights) into the integrated development plan, including, clinical plans and labeling strategy ; Appreciates translation of clinical data into claims and ... and in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** Global Program Leads within the ICV Global Program Leadership… more
- Merck (Rahway, NJ)
- …with worldwide regulations, company policies and standard operating procedures. The Senior Director , Global Label Operations, is a strategic multi-team leader ... **Job Description** The Global Clinical Supply (GCS) organization within our Research...External Collaborations). GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical… more
- Ascendis Pharma (Princeton, NJ)
- Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs ... Sciences team for the US business, the Associate Medical Director supports the US Medical Director for...and implementation of the product medical and medical launch strategy as well as working intricately within the other… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …guidelines. Organizational Relationship/Scope: + This position reports to the Head of Global Medical Affairs. The Senior Medical Director will interact with ... Global Medical Department, Marketing, Sales, Research and Development, strategy /portfolio management, Regulatory Affairs, and Pharmacovigilance. External collaboration includes… more
- Novo Nordisk (Plainsboro, NJ)
- …may serve as chair of Core Medical Team, at the discretion of the Executive Director + Represent NNI Medical Affairs on Global Core Medical Team (CMT) + ... ready to make a difference? The Position The Medical Director serves as the subject matter expert for our...interface with key stakeholders across CMR, Marketing, and the Global organization to drive scientific exchange and communication with… more
- Sumitomo Pharma (Trenton, NJ)
- …for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based ... regulatory activities for assigned project(s) in line with the global registration strategy of the product +...support the successful submission and achievement of target product labeling + Responsible for creating and reviewing SOPs and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and improving the lives of patients for generations to come. As an Associate Director , Global Regulatory Affairs, you will act as the Regional Regulatory Lead ... manage and oversee simultaneously. You will define the regulatory strategy , plans and objectives for assigned products or projects....assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other programs. You… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be responsible for contributing and/or devising the clinical pharmacology ... strategy supporting development assets within the Organon portfolio. This...Lead will serve as the medical monitor and/or study director responsible for the execution (in conjunction with the… more
- Sanofi Group (Morristown, NJ)
- …relationships with FDA are established and maintained. + Provides input into the global organization for labeling strategies of marketed drugs. + Demonstrates ... **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion...training and team leadership opportunities. We are an innovative global healthcare company with one purpose: to chase the… more
- J&J Family of Companies (Titusville, NJ)
- …via matrix interactions also includes individuals from project management, TA strategy , global regulatory affairs, finance, legal, quality assurance, quality ... for humanity. Learn more at https://www.jnj.com/. **POSITION SUMMARY:** The Senior Director , Clinical Leader (CL) is responsible for development and execution of… more
- Merck (Rahway, NJ)
- **Job Description** The Global Clinical Supply (GCS) organization within our company's Research Laboratories (manages the end-to-end clinical supply chain for the ... and 200+ External Collaborations). GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites across more… more
- Merck (Rahway, NJ)
- **Job Description** The Global Clinical Supply (GCS) organization within our company's Research Laboratories manages the end-to-end clinical supply chain for the ... and 200+ External Collaborations). GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites across more… more
- GRAIL (Trenton, NJ)
- …North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, ... please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership with...to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US Regulatory Affairs… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. Tanabe Pharma Corporation has discovered and produced several ... development, distribution, importation, export, and vendor management in cooperation with Director of Commercial Supply Chain. This incumbent will drive supply chain… more