- Merck & Co. (Rahway, NJ)
- …, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's ... and effective implementation and oversight model to maintain best in industry regulatory compliance.The Vice President Regulatory Affairs , General Medicine… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo. The candidate will collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical ... to author the Dose Preparation Instructions and address questions from the clinical sites. The candidate will optimize and continuously improve the Pharmacy Manual… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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 ... technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements… 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 ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Eisai, Inc (Nutley, NJ)
- …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 ... Medical Affairs /MSL training and continued education plans related to Eisai's...regional medical directors and MSL leadership, Publications, Medical Communications, Clinical Development, Biostatistics, Field HEOR, Patient Advocacy, and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relationships with key stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs .Facilitate ... language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of… 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 ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Johnson and Johnson (Raynham, MA)
- …INTERNAL PROCESS SUPPORT Work with cross-functional partners, including but not limited to R&D, Clinical Affairs , Regulatory Affairs , Health Economics & ... potential patient safety issues. This position involves cross-functional collaboration with Clinical Affairs and HEMA teams generating and disseminating… 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 ... Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in the… more
- Merck & Co. (Rahway, NJ)
- …scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research… 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 ... Process Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for ensuring Daiichi Sankyo's… more
- Coherus BioSciences (Redwood City, CA)
- …and medical communication. You will partner with Commercial, Research and Development, Clinical Development, and Regulatory Affairs . Candidates will leverage ... research collaborations across Coherus portfolio products Oversee and execute Medical Affairs sponsored clinical studies including development and review of… more
- Abbott (Santa Clara, CA)
- …other cross-functional deliverables. Facilitates communication between Sales and Marketing, R&D, Clinical R&D, Regulatory Affairs , Library Services, Product ... regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. Interacts...Performance Group (PPG), Quality Engineering, Clinical Affairs or Clinical Science,… more
- Legend Biotech USA, Inc. (Baton Rouge, LA)
- …point of contact between investigators and members of the Legend Biotech Medical Affairs and Clinical Development teams; Addressing AE management and education ... Science Liaison (South Central) as part of the Medical Affairs team based in TN, KY, AR, LA, or...Direct education for healthcare professionals treating oncology patients on clinical data, adverse event management, and mechanism of action… 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
- Abbott (Alameda, CA)
- …priorities, and to be flexible when priorities change. Working knowledge of GCP, Clinical and Regulatory Affairs . Proficient with Microsoft Suite. Travel ... 160 countries. JOB DESCRIPTION: The Opportunity: The CRA III will assist in the clinical execution and management of all aspects of assigned clinical studies.… more
- Eisai, Inc (Nutley, NJ)
- …of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These deliverables include ... interactions with KOLs (ie by MSLs), advisory boards, internal medical affairs strategic communication tools (ie medical narratives) and other internal medical… more
- Sun Pharmaceutical Industries (Princeton, NJ)
- …M anage HEOR projects across product lifecycles, collaborating with cross-functional teams ( clinical , medical affairs , regulatory ) to support enterprise ... a subject matter expert within the enterprise, working with teams across medical, clinical , regulatory , and commercial functions to support and lead business… 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
