- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for the global ... Salary Transparency Language:The base salary range for the Executive Director , Global Regulatory Affairs -...practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to regulatory agencies. Supervise designated personnel. Relationships Report to the Director Regulatory Affairs . Develop and maintain positive rapport ... Position Manage and oversee all assigned projects/products/processes. Assist the Director in assuring Novo Nordisk compliance with internal SOPs...and working relationships with other personnel in Regulatory Affairs , CMR, and other local and… more
- Novo Nordisk Inc. (WA)
- …locally and globally. Relationships Reports to the Market Access and Public Affairs Senior Director , Policy. Other internal relationships include a dotted ... About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare...in Plainsboro, NJ or Washington, DC. The Position The Director - US Tax, Trade, IP works on complex… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is ... strategy and quality plan closely aligned with the Global Oncology Medical Affairs (GOMA), Oncology Business Unit (OBU) and Specialty Business Unit (SBU) Medical… more
- Merck & Co. (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Job DescriptionThe Executive Director (Distinguished Scientist)...strategy and design, protocol authoring, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international… more
- Merck & Co. (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Job DescriptionThe Senior Director (Sr. Principal...including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director … more
- Eisai, Inc (Raleigh, NC)
- …or site manufacturing changes in collaboration with Product Quality, Regulatory Affairs , and Technical Operations.Establish productive business relationships ... interface experiences with the Finance, commercial Sales and Marketing organizations, regulatory affairs , and with third party manufacturers.Strong knowledge of… more
- Genmab (NJ)
- …Management, Clinical Operations, Medical, Biomarker Management, Biostatistics, Medical Writing, and Regulatory Affairs to ensure alignment of data strategy with ... and protocol deviations and is a key driver for inspection readiness, regulatory compliance, and successful data submissions.The Associate Director will lead… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/Associate Director , has primary responsibility for ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… more
