- 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. (Rahway, NJ)
- …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)
- …tactics that will Improve strategic planning Expand and improve the quality of clinical research Increase accuracy of medical and marketing assessments Improve ... About the Department The Clinical , Medical and Regulatory (CMR) department...Relationships Reports to Executive Director or Vice President Medical Affairs . Has direct supervisory responsibility for field based Medical… 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
- 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
- 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
- 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
- Fred Hutchinson Cancer Center (Seattle, WA)
- … regulatory affairs . Certified IRB Professional (CIP) certification. Previous clinical research regulatory coordinator experience working within Fred ... as liaison for internal regulatory bodies (IRB, Clinical Research Support, Regulatory Affairs , etc.). Stay abreast of new impacts/areas of knowledge… more
- Merck & Co. (Rahway, NJ)
- …HTA submissions. 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 provide input into clinical , regulatory , payer/access, marketing and evidence generation strategy and… more
- Merck & Co. (North Wales, PA)
- …position resides in the V&I organization, which includes Global Medical and Scientific Affairs as well as Outcomes Research , and will support Pneumococcal ... and reimbursement. The incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial, and… 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
- Merck & Co. (North Wales, PA)
- …of an Executive Director, within the Value and Implementation, Outcomes Research the incumbent has the following responsibilities:1.) development of the integrated ... vaccines on a worldwide basis and 3.) development and implementation of Outcomes Research (OR) and Real World evidence programs to meet the value evidence needs… 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
- Merck & Co. (Rahway, NJ)
- …(including discovery research , biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations)Provide ... Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout sites in the USA, UK… 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
- Merck & Co. (Rahway, NJ)
- …functions including Global Science Engineering and Commercialization (GSEC), Quality, and CMC Regulatory Affairs , as well as, the GBO Leadership Team (LT). ... knowledge management tools and training programs for site and functional teamsPartner with regulatory affairs , quality and site tech ops to ensure manufacturing… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- … (MAPA), Customer Engagement and Integrated Solutions, Commercial Excellence, Legal, Regulatory Affairs , Compliance and other relevant NNI departments to ... cross-functionally with multiple functions and groups throughout the US organization, Clinical development, Research & Early Development, other affiliates, and… 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
