- Merck (Rahway, NJ)
- …of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. Specifically, the Director may be ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects;… more
- SMBC (Jersey City, NJ)
- …management of stress testing processes, ensuring robust risk management and regulatory compliance. **Role Objectives** + Scenario Development: Apply and leverage ... results to identify potential risks and vulnerabilities within the bank's portfolio + Regulatory Compliance: Ensure all stress testing activities are in line with … more
- J&J Family of Companies (New Brunswick, NJ)
- …epidemiologic research to support post-market safety and effectiveness, regulatory submissions, product development, product launches, value assessments, predictive ... abstracts and presentations. **Additionally, the person will also be assisting with the Regulatory team within the MT Epi-RWDS that focuses on RWE for Regulatory… more
- Merck (Rahway, NJ)
- …Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to ... control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions. + **CMC RA** : Experience supporting/writing … more
- AbbVie (Florham Park, NJ)
- …scientific content of protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses. + Has overall responsibility for oversight ... activities with internal stakeholders (ie, commercial, clinical operations, discovery, statistics, regulatory , etc ) as they relate to on-going medical affairs… more
- Bristol Myers Squibb (Princeton, NJ)
- …solutions. The role oversees diagnostic development from concept through regulatory approval and commercialization, manages strategic alliances, and ensures ... capabilities. Drive the development of IVD products from concept through regulatory approval, commercialization, and lifecycle management. + Establish and manage… more
- Sanofi Group (Morristown, NJ)
- …exchange and engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs to develop and launch first ... with internal experts from Global and Local Medical, Clinical Development, and Regulatory teams to develop, prioritize, and execute study design and analytical… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory , Outsourced Manufacturing and Project Management partners to develop ... and supports the resolution of CAPAs . Partner with Regulatory to ensure labels meet global regulatory ...with MA/ MS or MBA OR 2+ Years with PHD or PharmD We offer you the opportunity to… more
- Ascendis Pharma (Princeton, NJ)
- …all applicable laws and regulations and as appropriate, local and foreign regulatory reporting requirements and for signal detection, evaluation and risk management. ... reports received from any source are reviewed according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures. . Liaises with Medical… more
- Colgate-Palmolive (Piscataway, NJ)
- …with internal entities such as the Product Development, Legal and Regulatory departments as well as external groups including subsidiaries, trade associations ... Product Development, Consumer Affairs, Legal Department, Government Affairs, and Regulatory Affairs. + Representation of Colgate's key business interests on… more