- Daiichi Sankyo, Inc. (Bernards, NJ)
- …within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs .Facilitate operational meetings with ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Manage… more
- Merck & Co. (North Wales, PA)
- …to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's Research Laboratories ( Research & ... Job DescriptionPosition Description:The Vice President, Regulatory Affairs , General Medicine, will contribute… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … agencies. Supervise designated personnel. Relationships Report to the Director Regulatory Affairs . Develop and maintain positive rapport and working ... About the Department The Clinical , Medical and Regulatory (CMR) department...relationships with other personnel in Regulatory Affairs , CMR, and other local and… more
- Eisai, Inc (Nutley, NJ)
- …is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, ... profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the planning and execution of Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary: This position manages… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Device Development and Commercialization process.Experience with developing and documenting regulatory strategies in coordination with clinical plans and ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: Responsibility for… more
- Merck & Co. (Rahway, NJ)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and ... Senior Director has primary responsibility for the planning and directing clinical research activities involving new or marketed Neuroscience Medicines.… more
- Merck & Co. (Rahway, NJ)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; ... Trial Support, Cross-Functional Teamwork, Data Analysis, Hematology, Intellectual Curiosity, Medical Research , Oncology, Regulatory Affairs Compliance, … more
- Merck & Co. (Rahway, NJ)
- …the Final Study Report Maintain contact with all stakeholders (project leader, regulatory affairs , quality assurance etc.) and keeps them informed of ... and organization of paper and Electronic Data Capture (EDC) clinical studies that meet scientific and regulatory ...the study progress.May be the Global Clinical Research (GCR) representative in the project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior ... Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable...located in the Americas and EU and collaborate with Research QA and Development QA to provide QA advise… more
- Merck & Co. (North Wales, PA)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; ... (Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed Oncology medicines.… more
- Merck & Co. (Rahway, NJ)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and ... (Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in the… more
- Merck & Co. (North Wales, PA)
- …and reimbursement. The incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and ... and barriers to reimbursement and market access, and provides input into clinical , regulatory , payer/access, marketing and evidence generation strategies and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations, Clinical ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disordersJob...Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo. The candidate will collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical ... from internal and external stakeholders. Collaboration with external stakeholders (eg, research pharmacists, clinical study partner management) may also be… more
- Legend Biotech USA, Inc. (Baton Rouge, LA)
- … research activities, publications, education, consulting, and other Medical Affairs initiatives. The MSL will provide credible, compliant, fair-balanced and ... between investigators and members of the Legend Biotech Medical Affairs and Clinical Development teams; Addressing AE...primary local point of contact for investigators and their research staff who may participate in company sponsored and… more
- Novo Nordisk Inc. (San Francisco, CA)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... trials in all stages of development. Incumbents have a deep scientific and clinical education and experience. Within Field Medical Affairs , this position… more
- Eisai, Inc (Nutley, NJ)
- …is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, ... of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These deliverables include… more
- Merck & Co. (Rahway, NJ)
- …several key responsibilities with in the Global Medical and Scientific Affairs (GMSA) team. These responsibilities highlight the comprehensive and collaborative ... and maintenance of GSVC content in collaboration with Medical Affairs stakeholders. This includes managing external vendors for content development.Reviewing… more
- Merck & Co. (North Wales, PA)
- …Vice President in BARDS and will work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs .--The AVP provides leadership ... Job DescriptionIn Biostatistics and Research Decision Sciences (BARDS), a distinguished department within our renowned Research and Development division,… more
