- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …processes for record keeping and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high ... for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons...documents as well as for the review of country labeling deviations.Ensure Compliance with Labeling … more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Legal Director (FDA promotion/ Labeling Drugs & Vaccines) The position provides legal support to the Human Health Division, ... counseling clients in the areas of FDA promotion and labeling of drugs and vaccines.- The position also provides...also provides legal support to the Research Division and Compliance department on various matters. The role provides legal… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Medical Consult and Review Physician (MCRP) previously called Global Medical Information Physician (GMIP) for Oncology provides clinical expertise ... the Promotional Review Team (PRT), and the US and Global Medical Affairs Teams. In PRT, the MCRP is...stakeholders.Active participant on select teams to provide insights on labeling language and anticipate activities related to labeling… more
- Takeda Pharmaceuticals (Columbus, OH)
- …product strategy and information in the CCDS, when available. + Provide information to Global Labeling Compliance , as required, to support internal and ... therapies to patients worldwide. Join Takeda as an Associate Director , Global Labeling Lead where...standards and guidelines. You will provide strategic and tactical labeling expertise to teams while ensuring compliance … more
- AbbVie (Lake Bluff, IL)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , Regulatory Affairs, Strategic Global Labeling - Combination ... documentation for healthcare providers and end user. Under the Director of Strategic Labeling , they establish combination...submissions (pre and post approval) with an understanding of Global requirements to lead the Labeling Sub… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …processes for record keeping and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high ... for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons...documents as well as for the review of country labeling deviations. + Ensure Compliance with … more
- Bristol Myers Squibb (Princeton, NJ)
- …more: careers.bms.com/working-with-us This position will provide oversight of a team of Global Labeling Strategists responsible for driving labeling strategy ... and maintenance of global compliant labels. Position will also serve as Global Labeling Lead for assigned products. **Responsibilities include, but are not… more
- Ascendis Pharma (Princeton, NJ)
- …and the Americas and supporting global needs as required. The RA Associate Director , Labeling will be overall responsible for ensuring compliance with US ... The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for...labeling processes and infrastructure . Work closely with global labeling managers to ensure consistency and… more
- Gilead Sciences, Inc. (Boston, MA)
- …and help create possible, together. **Job Description** Job Description Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs ... acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling creates, updates, and maintains product information and labeling … more
- Merck (North Wales, PA)
- **Job Description** **Position Description:** **Legal Director (FDA promotion/ Labeling Drugs & Vaccines)** The position provides legal support to the Human ... not limited to: + Food, Drug, and Cosmetics Act compliance + Advertising and promotion + Product labeling...to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its… more
- Lundbeck (Deerfield, IL)
- …in the greater United States** **SUMMARY:** The Director , US Regulatory Affairs Global Strategic Labelling, oversees the process and compliance of the ... Director US Regulatory Global Strategic Labelling...to ensure adherence to processes and procedures related to global labelling development, maintenance, and compliance . +… more
- AbbVie (Boston, MA)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director , Global Regulatory Lead, is responsible for developing and ... Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team… more
- Organon & Co. (Plymouth Meeting, PA)
- …and implementation of medical strategies and activities for Headquarters. The Executive Director leads the following teams: Global Medical Strategy, Medical ... **Job Description** **The Position** The Global Strategy and Medical Capabilities Lead oversees the...with stakeholders consulted by Regulatory Health Authorities. + Drive compliance with all applicable Organon guidance documents and SOPs.… more
- Sanofi Group (Bridgewater, NJ)
- The Associate Director RA serves as the regulatory lead on Review Committees (RCs). As the RC RA representative, work with brands on competitively positioning ... assigned products appropriately while maintaining compliance with applicable FDA regulations, company policies, and applicable Industry Guidelines for the… more
- Sanofi Group (Cambridge, MA)
- About the Role The Associate Director , US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare ... with brands on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations and company policies for the… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director , Pipeline Head for Neuroscience, Global Health Economics, Value, and Outcomes Date: Apr 15, 2024 Location: Parsippany, United States, New Jersey, ... Parsippany, New Jersey** The goals and objectives of the Global Health Economics, Value, and Outcomes department is to...world data studies, surveys, and economic models. The **Senior Director , Pipeline Head for Neuroscience** , will develop the… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director , Pipeline Head for Immunology, Global Health Economics, Value, and Outcomes Date: Apr 15, 2024 Location: Parsippany, United States, New Jersey, ... Parsippany, New Jersey** The goals and objectives of the Global Health Economics, Value, and Outcomes department is to...world data studies, surveys, and economic models. The **Senior Director , Pipeline Head for Immunology** , will develop the… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …promotional information, materials, and activities to ensure consistency with product labeling and with all applicable regulations. TheSenior Director , ... compliant promotion and scientific engagement activities and review submission packages, labeling revisions, and promotional materials for regulatory compliance … more
- BeiGene (San Mateo, CA)
- …draft papers + Contributes to and facilitates the development of a global Pharmacoepidemiology (PE) strategy ** Compliance , Standards, Training & Project ... **General Description:** The Senior Medical Director serves as the Product Safety Physician for...programs and creates and maintains a single interpretation of global safety data for developmental and marketed products. With… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** Review promotional claims and materials for BI Rx drug promotion for compliance with Food Drug Cosmetic Act (FDCA) and for consistency with product ... labeling . Participate in Human Pharmaceutical Review Committee, providing regulatory...of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate… more
