- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, 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. (Bernards, 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. (Bernards, 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
- Bristol Myers Squibb (New Brunswick, NJ)
- …GxP global regulations necessary for appropriate strategy setting, decision making, and quality oversight to ensure BMS complies with regulatory requirements. + ... work and in their personal lives. Read more: careers.bms.com/working-with-us . The Senior Director , Risk Based Quality Management leader will work closely with… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Director , Translational Medicine (TM), will be primarily responsible for creating plans for ... in translational studies and with external scientific experts. Reporting into the Senior Director of the Translational Medicine (TM) group, the Director , TM will… more
- Bristol Myers Squibb (Madison, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . ** Director , Medical Safety Assessment Physician (Immunology)** **Functional Area Description** ... is responsible for ensuring the safety of our medicines. WWPS pharmacovigilance and pharmacoepidemiology deliverables include single case and aggregate safety… more
- Bristol Myers Squibb (Madison, NJ)
- …presentation, leadership, and strategic skills for their reports. + Provide oversight and ensure quality of disease-specific Lymphoma medical training ... lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Medical Director , US Lymphoma/CLL will report to the Executive Director ,… 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 - Clinical (Neuroderm), may be called...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
- AbbVie (Florham Park, NJ)
- …resources and ensures communications are supported by medical communication standards, pharmacovigilance standards, SOP's and all other quality and compliance ... Park, NJ preferred. Will consider remote candidates. The Assistant Scientific Director is responsible for ensuring scientific pull-through of key medical strategies… more
- AbbVie (Florham Park, NJ)
- …Participates in cross-functional teams to generate, deliver, and interpret high- quality clinical data supporting overall product scientific and business strategy. ... site personnel, and AbbVie study staff. *Has overall responsibility for oversight of clinical studies, monitoring overall study integrity, and review,… 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
