- Merck & Co. (Rahway, NJ)
- …-The US lead will work closely with cross-functional stakeholders, including US Medical Affairs (USMA) Leadership, Global Medical Scientific Affairs (GMSA) ... organization.-- The US lead will work directly with the Global and US TAs to assess and prioritize TA...medical modernization efforts and transformational change within US medical affairs , fostering a culture of continuous improvement to achieve… more
- Repligen (Waltham, MA)
- OverviewThe Senior Director, Global Regulatory Affairs will report directly to the VP, Global Quality.This role will be accountable for the Regulatory ... to Senior Management across the organization, is essential.ResponsibilitiesThe Senior Director Global Regulatory Affairs must have the ability to:Lead &… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. JOB SUMMARYThe Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to drive ... quality strategy and quality plan closely aligned with the Global Oncology Medical Affairs (GOMA), Oncology Business...expertise in managing many aspects of quality in an international , global context in a regulated health… more
- Merck & Co. (North Wales, PA)
- …with evolving standards beyond 2025 ( ie IDMP related activities and submissions to Global Health Authorities ) . Th is will result in positioning the Company ... data management principles, dataflows and activities that occur at global and regional level as well as the requisite...Fa nd EMA PMS) - Represent the Company in international trade association committees and meeting groups associated with… more
- Merck & Co. (Rahway, NJ)
- …Solving, Process Improvements, Project Management, Project Risk Assessments, Regulatory Affairs Management, Regulatory Reporting, Regulatory Training, SAP Global ... Job DescriptionReporting to the Customs & International Trade (CIT) Tariff Classification Associate Director, the Senior Specialist will work closely with our… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …success criteria are addressed ie clinical development programs, data generation needs, international guidelines, required efforts by global functions o Drive ... Early Development, Development, innovation hubs across NN, other affiliates, and global . We're looking for individuals who are enterprise thinkers, inclusive… more
- Merck & Co. (Rahway, NJ)
- …Project Management Information Systems (PMIS), Project Risk Assessments, Regulatory Affairs Management, Regulatory Reporting, Regulatory Training, SAP Global ... Job DescriptionDescription Reporting to the Customs & International Trade (CIT) Valuation Associate Director, the Senior Specialist position's core responsibilities… more
- Eisai, Inc (Raleigh, NC)
- … affairs , and with third party manufacturers.Strong knowledge of international importing/exporting shipping, CBP compliance, and EU VAT compliance with ... relationship is with ESI or ECL (example: Patheon for Lenvima). The Global Supply Chain function collaborates with Regional (Americas, EU, and JP) Commercial,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for ... for purpose and compliant with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical… more
- Merck & Co. (North Wales, PA)
- …development of American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by local subsidiaries in their HTA submissions. The ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… more
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