- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research 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 ... regulatory reporting, publication, and presentation at national and international meeting.-They will lead cross-functional product development teams that oversee… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Sr. Director , Data Quality and Integrity (Global R&D & PV QA) ensures high ... process improvements. Collaborating with the Global QMS eCompliance team, the director oversees QA plans, promotes data governance, and engages stakeholders to… 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)
- …the guidance of a senior leader, an Associate Principal Scientist/Associate Director , has primary responsibility for planning/managing real world and economic ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Liaisons to ensure successful implementation of CDx and data collection Supports Regulatory affairs in providing content and providing review of documents ... clinical trial sample testing activities and data capture to support CDx regulatory submission or associated drug regulatory submissions. Contributes to CDx… more
- Genmab (NJ)
- …with key stakeholders within Global Development Operations (GDO), Medical Affairs , Medical, and/or CROs, to enable expedited, predictive delivery for ... and tactical operational plans aligned to the commercial and regulatory objectives.Excellent stakeholder management, concise written communication, ability to… more
- Merck & Co. (Rahway, NJ)
- …Analysis, Problem Solving, Process Improvements, Project Management, Project Risk Assessments, Regulatory Affairs Management, Regulatory Reporting, ... Job DescriptionReporting to the Customs & International Trade (CIT) Tariff Classification Associate Director , the Senior Specialist will work closely with our… more
- Merck & Co. (Rahway, NJ)
- …Project Management, Project Management Information Systems (PMIS), Project Risk Assessments, Regulatory Affairs Management, Regulatory Reporting, ... Job DescriptionDescription Reporting to the Customs & International Trade (CIT) Valuation Associate Director ,...Customs & International Trade (CIT) Valuation Associate Director , the Senior Specialist position's core responsibilities are to… more
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