- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. The Director , Global Labeling is responsible for the leadership and oversight of the ... actively contribute to the development and implementation of regulatory labeling strategy and documentation for marketed products...Salary Transparency Language:The annual base salary range for the Director , Global Labeling is from… more
- Merck & Co. (Rahway, NJ)
- …with worldwide regulations, company policies and standard operating procedures. The Senior Director , Global Operations Planning, is a strategic multi-team leader ... Job DescriptionThe Global Clinical Supply (GCS) organization within o ur...External Collaborations). GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical… more
- Lundbeck (Deerfield, IL)
- …+ Demonstrated team leadership and motivation of staff to successfully execute global labeling regulatory strategies. + Knowledge of development and registration ... Director US Regulatory Global Strategic Labelling...labeling challenges during development and post-approval maintenance of global labelling activities, ensuring cross functional communication and execution… more
- Novo Nordisk Inc. (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) Collaborate ... 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
- Insmed Incorporated (NJ)
- …, distribution, returns, reconciliation, destruction, and logistics for global clinical programsDefine and implement comprehensive sourcing strategies, engaging ... analytics), drive process optimization, resilience, sustainability, and operational excellenceOversee global depot inventory, labeling strategies, temperature excursion… more
- Insmed Incorporated (NJ)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... we're in. Are you?About the Role:We are seeking a highly experienced Senior Director , DSPV Medical Safety to help us expand what's possible for patients with… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe 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
- Formation Bio (New York, NY)
- …deliver best-in-class IP positions. We expect this person to create and influence strategy , assist with deal and portfolio decisions, and directly impact whether our ... position and considering potential asset exit opportunities Drive IP strategy and negotiation in complex pharma/biotech transactions, including working closely… more
- Lundbeck (Deerfield, IL)
- …and contributes to strategic initiatives. **ESSENTIAL FUNCTIONS:** + Drives medical strategy in collaboration with Medical Director (s) and leads development, ... Associate Director Medical Affairs - Neurology Requisition ID: 7013...the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With… more
- Organon & Co. (Plymouth Meeting, PA)
- **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
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director , Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical and ... decision making to execute these key deliverables in compliance with global regulations and internal processes. Effective communication and influence with internal… more
- GRAIL (Atlanta, GA)
- …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
- Endo International (Hobart, NY)
- …develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering ... Quality Assurance groups successfully issue and control labels and labeling confirming that issuance is on time and accurate....metrics for groups in conjunction with the Site Quality Director , and manages the performance to those goals. Ensures… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be responsible for ... to foster cross-functional collaboration and driving alignment of the labeling strategy and labeling content....approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight Committee - GLOC) providing… more
- 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
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for ... Labeling cross-functional teams driving cross-functional collaboration and alignment of the labeling strategy and labeling content. Interface with Senior… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director , Regulatory Affairs Global Regulatory Strategy is ... TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the… 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
- AbbVie (Mettawa, IL)
- …brand strategy + Determine, in collaboration with cross functional leaders, the global development strategy for new or marketed products and contribute to ... global team environment. Ability to interact externally and internally to support global business strategy . Additionally, this person must be able to interact… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role is ... Team consisting of regional regulatory scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and GRA- Global Labeling and Product Communications. Ensures clear and… more
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