- 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 the ... strategy and quality plan closely aligned with the Global Oncology Medical Affairs (GOMA), Oncology Business Unit (OBU) and Specialty Business Unit (SBU) Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for ensuring ... and compliant with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations,… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …QA oversight.Drive innovative process improvements across RD, PV, and Medical Affairs by leveraging emerging technologies and industry best practices.Ability to ... and implement proactive strategies to address data integrity issues identified during regulatory inspections, such as those from Quality Events, Audits Findings and … 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, the Senior Specialist position's core responsibilities… more
- Tris Pharma (Monmouth Junction, NJ)
- …medical writing guidance and supports cross-functional teams (ie, clinical development, regulatory affairs , biostatistics, external vendors, etc.) Oversees, and ... pain and addiction addressing unmet patient needs. We have more >150 US and International patents and market several branded ADHD products in the US We also license… more
- Genmab (NJ)
- …Management, Clinical Operations, Medical, Biomarker Management, Biostatistics, Medical Writing, and Regulatory Affairs to ensure alignment of data strategy with ... protocol deviations and is a key driver for inspection readiness, regulatory compliance, and successful data submissions.The Associate Director will lead… 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
- 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
- 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
