- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading ... portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr...(GRA) and will report to the Sr Director, Labeling, Policy and Intelligence. The position will be based in… more
- Genmab (Plainsboro, NJ)
- …to fulfilling our purpose.The RoleGenmab is searching for an experienced Director, Global Clinical Drug Supply to be part of Global Clinical Drug Supply (GCDS) ... operational excellence, strategic planning, and innovation implementation for the Global Clinical Drug Supply team. The individual will have the ability to exercise… more
- Genmab (Plainsboro, NJ)
- … supply plan, milestone tracking, IMP manual, etc.Ensure GxP compliance & regulatory guideline compliance during all drug supply planning tasks, activities, ... best, and authentic is essential to fulfilling our purpose.Genmab is seeking a Clinical Drug Supply Manager to join our Global Clinical Drug Supply (GCDS)… more
- Merck & Co. (Rahway, NJ)
- …candidate should have a strong track record in biologics product development/ regulatory filing/ drug delivery/ complex formulation and process development ... In summary, our team enables the translation of preclinical candidates into non-oral drug products. Our team is looking for a strong candidate for the position… more
- Merck & Co. (Rahway, NJ)
- …team is responsible for the research and development of sterile & parenteral drug products for biologics as well as the biopharmaceutics support for the oral ... biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Merck & Co. (Rahway, NJ)
- …In summary, our team enables the translation of preclinical candidates into non-oral drug products.We are seeking a highly motivated candidate for a strong candidate ... of Principal Scientist (R5) within the team focused on developing parenteral drug products of small molecule and/or intermediate modalities. The successful candidate… more
- Genmab (NJ)
- … drug development pertaining to statisticsExperience with the relevant regulatory requirements for biostatistics processes and SOPsExperience with regulatory ... scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for performing a wide range of activities to support the release of drug products for human use. This position is responsible for quality and maintaining ... procedures, and all applicable regulations.Key Responsibilities Manage the team responsible for drug product batch record review and drug product release… more
- Insmed Incorporated (San Diego, CA)
- …will provide clinical and scientific support to clinical development and operations, regulatory , medical affairs, drug safety, and quality assurance teams, as ... scientific review of information to support the development and updates for regulatory documents (ie, IND submissions, IND Annual Updates, DSUR, and Investigator… more
- Merck & Co. (North Wales, PA)
- …processes (SOPs) and software development life cycle (SDLC)US and/or worldwide drug or vaccine regulatory application submission experience including the ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be ... of generating early clinical development plan and Investigational New Drug applications.Developing of clinical development strategies for investigational or marketed… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... activities assuring the manufacturing resources comply to all safety, GXP, regulatory and business processes or procedures Ensure the operating efficiency of… more
- Merck & Co. (North Wales, PA)
- …that include coordinating the activities of a programming team.US and/or worldwide drug or vaccine regulatory application submission experience at the leadership ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Genmab (NJ)
- …portfolio. The employee will also provide input to Genmab clinical drug development programs to ensure data management excellence.Responsibilities:Contributes to and ... all phases of clinical trials.Experience with clinical trials and the drug development processSignificant experience leading data management activities in clinical… more
- Genmab (Plainsboro, NJ)
- …through collaboration with US Commercialization, Global Medical Affairs, Clinical Development, Regulatory , and other cross functional teams.We have a hybrid model ... and tactics with appropriate use of resources.Work with clinical development, regulatory , commercial, and market access teams to incorporate insights into product… more
- Genmab (Plainsboro, NJ)
- …role will include stakeholders in the business domains Field Operations, Medical & Regulatory Affairs and US and Japan Market and Commercial Teams (and others) and ... architects and Genmab Security Operations TeamBusiness leaders (eg, VP Medical Affairs, VP Regulatory Affairs, GM Genmab US, IT Lead in Japan)Peers within IT&D, such… more
- Genmab (Plainsboro, NJ)
- …issues to CPL in a timely mannerExecute operational strategies related to drug supply, regulatory submissions, and recruitmentBudget and PlanningAssist in the ... leading clinical projectsExperience managing/guiding internal (cross-functional) and external (CRO, regulatory authorities) teamsSome experience with operational management and budget… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …thermal energy principals, mechanical maintenance techniques, and electromechanical theoryEnsures regulatory and job training remains current by promptly completing ... local, state and federal regulations including and equivalent to Federal Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and… more
- Merck & Co. (Rahway, NJ)
- …and breadth of scientific and technical experience to lead small molecule drug substance process development teams to develop safe, robust and productive processes, ... development including performing unit operations common in small molecule drug substance process development such as chemical reactions, work-up, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of Tolerances (OOTs), Change Controls, Root Cause Analysis and FMEA's.Ensures regulatory and job training remains current by promptly completing required training. ... local, state and federal regulations including and equivalent to Federal Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and… more
