- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to streamline the product lifecycle process and develop risk mitigation strategies. Provide quality oversight and strategic quality advice to the CSPV ... around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports...advise wherever necessary. Ensure requirements are in place for quality oversight of marketed products in collaboration… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the development and ... review teams as well as with business partners to achieve high quality and accurate labeling in support of business objectives.ResponsibilitiesPreparation of new and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global ... proper resource allocation for achieving successful project deliverables. Provides oversight of all statistical programming activities performed by contractors in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global ... proper resource allocation for achieving successful project deliverables. Provides oversight of all statistical programming activities performed by contractors in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance , Regulatory/Risk Management, Quality Assurance, Medical Affairs, ... the global R&D business functions of Daiichi Sankyo. As a trusted partner, provide oversight of business demand to balance R&D IT portfolio and to ensure that… more
- Pfizer (New York, NY)
- **ROLE SUMMARY** The Pharmacovigilence AI Quality Oversight Lead is responsible to oversee the strategic development and implementation for the quality ... pharmacovigilance . This involves contributing to and participating in various quality oversight activities/committees established to drive discussion and… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Director , Medical Science MSES, will be primarily responsible for creating plans for ... and in creating and implementing experimental medicine studies. Reporting into the Senior Director of the Medical Science Early-Stage, the Director , MSES will… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …+ Provides regulatory support for MTPA Quality Assurance and Pharmacovigilance inspection ready efforts; and provides regulatory oversight during follow-up ... and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Development, may be called upon...teams. + Ensures the overall program execution of high quality , effective IND, CTA, NDA, NDS and MAA and… more
