- 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 ... as well as with business partners to achieve high quality and accurate labeling in support of business objectives....cross-functional labeling review team members. Responsible for the broad oversight of Core Data Sheets and US/EU label changes… 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
- 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, ... and Global IT functions of Daiichi Sankyo. As a trusted partner, provide oversight of technical and solutions architecture and design for the R&D IT portfolio… 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