- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs . Facilitate operational meetings ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Leads the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory ... business standards, process maps, and risk management for global processes across Global Regulatory Affairs and Clinical Safety . The Global Process… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational… more
- Genmab (Plainsboro, NJ)
- …information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director, Labeling, Policy ... and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team in other DSI governance process (DRF, G-PAD, GROC, GRSC etc.) Interfaces with clinical & pre- clinical groups, Regulatory CM&C and other appropriate ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: Responsible for… more
- Merck & Co. (Lower Gwynedd, PA)
- …(eg, neutralizing assays) will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility ... (AdVAnce) Vaccines bioanalytical group located at our Company's new state-of-the-art AdVAnce GxP research facility in West Point, PA. At this new facility, we will… more
- Genmab (Plainsboro, NJ)
- …the US healthcare market through collaboration with US Commercialization, Global Medical Affairs , Clinical Development, Regulatory , and other cross ... regional strategies and tactics with appropriate use of resources.Work with clinical development, regulatory , commercial, and market access teams to… more
- Merck & Co. (Rahway, NJ)
- …of experts in commercialization, regulatory affairs , statistics, medical affairs and manufacturing to manage clinical development projects; and assist ... Clinical Development, has primary responsibility for the planning and directing clinical research activities involving new or marketed drugs in the Oncology… more
- Merck & Co. (Rahway, NJ)
- …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 within the Atherosclerosis and Metabolism therapeutic… more
- Merck & Co. (Rahway, NJ)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; ... (Sr. 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; ... (Principal Scientist) has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. Our… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders across CDSE and more broadly within Clinical , Medical and Regulatory , Market Access and Public Affairs . Externally, this individual is ... strategies Collaborate with cross-functional teams, including members of the CDSE team, clinical development, medical affairs , regulatory , and commercial, to… more
- Insmed Incorporated (San Diego, CA)
- … clinical development team, partnering closely with heads of clinical operations, toxicology, regulatory affairs , commercial, pharmacovigilance, ... in pharmaceutical/biotech industry, across multiple phases of clinical research (Phase 1-3)Knowledge of ICH-GCP and FDA regulatory guidelinesDomestic… more
- Merck & Co. (Rahway, NJ)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects ... Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology.… more
- Insmed Incorporated (San Diego, CA)
- … clinical and scientific support to clinical development and operations, regulatory , medical affairs , drug safety, and quality assurance teams, as well as ... Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Senior Clinical Research Scientist (CRS) will support and work predominately… more
- Merck & Co. (North Wales, PA)
- …Product Directors, country affiliates, Global Market Access, and Global Medical and Scientific Affairs to ensure outcomes research programs are consistent with ... Job Description Director, Outcomes Research Vaccines Position Description Under the guidance of...identifies value evidence needs to provide strategic input into clinical and market development programs.-Develops the integrated evidence strategy… more
- Merck & Co. (South San Francisco, CA)
- …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 ...Simulation, Regulatory Affairs , and late-stage Clinical Research throughout research sites… more
- Tris Pharma (Monmouth Junction, NJ)
- …in support of Medical Affairs strategiesCoordinates MSL support for clinical activities and investigator-initiated research (IIR); Coordinates MSL support ... in positions of increasing technical and strategic responsibilityExcellent working knowledge of regulatory and industry standards related to Medical Affairs role… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety &...for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs , Quantitative Clinical Pharmacology, Clinical ... Safety and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , Translational Research , Research , Informatics Services,… more
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