- 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
- 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
- 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. (Rahway, NJ)
- …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
- Merck & Co. (Rahway, NJ)
- …incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates and may ... reimbursement and market access, and provides input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programsIn… 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
- Bausch Health (Bridgewater, NJ)
- …Regulatory Authorities for assigned brand products + Liaise with country-specific regulatory affairs personnel for international submissions and ... skills and values drive our collective progress and impact. The Senior Specialist Regulatory Affairs executes on the pharmaceutical regulatory strategies for… more
- Bausch Health (Bridgewater, NJ)
- …for assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions ... and values drive our collective progress and impact. The Associate Director, Regulatory Affairs handles regulatory development and post-approval/… more
