- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …but not limited to Translational Research & Biomarkers, Clinical Management, Global Regulatory Affairs , Global Clinical Development (late phase), Data & ... **Job Summary** The Senior Director will serve as the Translational Medicine CNS Therapeutic Area Head, reporting to the VP, Translational Medicine and Early… more
- J&J Family of Companies (Titusville, NJ)
- …numbers, your applications will be considered as a single submission. **Purpose:** The Director of Regulatory Medical Writing (RegMW) is recognized as a leader ... developing internal medical writers, and ensuring adherence to best practices and regulatory guidelines. The Director , RegMW has the authority to oversee… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, ... team and key stakeholders across different functional areas such as clinical, regulatory affairs , asset management, safety and clinical operation. + Familiar… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …action, with relevant colleagues, eg, Compliance, Legal, HR, Medical Affairs , Specialty Clinical, + Pre-Clinical/Pharmacology, Regulatory , Pharmacovigilance, ... Senior Director , Compliance & Ethics, Global R&D Date: Nov...experience working with Clinical and Pre-Clinical Research, Generics, Medical Affairs , Pharmacovigilance, Health Economics & Outcomes Research, Regulatory… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …including INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate with regulatory affairs on interactions with global health authorities. + Provides ... to post commercialization, with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director , GCD is responsible for all… more
- Organon & Co. (Jersey City, NJ)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control (CMC), project ... are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans....while ensuring the scientific and data integrity, rigor and quality thereof. The director may represent the… more
- Merck (Rahway, NJ)
- …microscopy and chromatography. + Collaborate with cross-functional teams, including research, development, quality control, and regulatory affairs , to ensure ... Leadership, Pharmaceutical Biology, Process Analytical Technology (PAT), Professional Networking, Quality Control Management, Regulatory Affairs Compliance,… more
- Sanofi Group (Morristown, NJ)
- …Development Plan (in close cooperation with other members of the team, particularly Regulatory Affairs and Health Economics); adjusts and updates the strategy ... **Job Title:** Senior Clinical Research Director **Location:** Morristown, NJ Cambridge, MA **About the...in the project in collaboration with the Safety Officer, Regulatory Strategist, Statistics and other key functional representatives to… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …for payer insights, pricing trends, and access performance metrics. + Ensure data quality , integration, and compliance with regulatory and privacy standards (eg, ... Associate Director , IT - Value & Access Date: Nov...GDPR). **Cross-Functional Collaboration** + Work closely with Commercial, Medical Affairs , Regulatory , and Legal teams to ensure… more
- Ascendis Pharma (Princeton, NJ)
- …PV Compliance team will provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits + ... employees to grow and develop their skills. The Associate Director , ICSR Management Team reports to the Director...PV Vendor processing ICSRs for Ascendis Products. + Performs Quality Checks of processed ICSRs and provides feedback to… more