- Merck & Co. (Rahway, NJ)
- …globally across Global Regulatory Affairs CMC (Global Regulatory Affairs & Clinical Safety), Research and Development (R&D), Manufacturing, and ... This individual will be a senior member of the Regulatory Affairs CMC organization and will also...modality or traditional solid-oral small molecules and includes pre-approval regulatory strategy and submissions (global clinical and… more
- Insmed Incorporated (San Diego, CA)
- …for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director, Regulatory Affairs will serve as the regulatory leader ... communicate issues, outcomes, and risks to the VP of Regulatory Affairs and relevant teamsWith oversight from...therapy or orphan (rare) diseasesPrior experience serving as the regulatory lead on cross functional teams (CMC, clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …health authority regulatory requirements particularly in the areas of Medical Affairs and Clinical Development; Must have a strong understanding of ... in quality and compliance.Evaluate risks impacting GxP compliance within Medical Affairs , driving ongoing improvements to meet regulatory requirements and… 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)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and ... Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology.… more
- Merck & Co. (Upper Gwynedd, PA)
- …with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and ... report to an Associate Vice President in the Oncology Clinical Research Group. Under the guidance of...Research , Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance… more
- Legend Biotech USA, Inc. (Detroit, MI)
- … research activities, publications, education, consulting, and other Medical Affairs initiatives. The MSL will provide credible, compliant, fair-balanced and ... point of contact between investigators and members of the Legend Biotech Medical Affairs and Clinical Development teams; Addressing AE management and education… more
- Eisai, Inc (Cincinnati, OH)
- … Senior management with strategic and tactical planning, working collaboratively with Medical Affairs and Clinical Development teams for support of clinical ... international regulatory /ethical guidelines relevant to the pharmaceutical industry & clinical trial conduct, and to ensure compliance with these external as… more
- Merck & Co. (Boston, MA)
- …(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
- Eisai, Inc (Nutley, NJ)
- …all MSL activities. Identify and report key scientific, clinical and research insights from KOLs to Medical Affairs . Training/Education Resource Maintain and ... Sr. MSL) is a field-facing representative of US Medical Affairs with a primary responsibility of engaging in the...of institutions focused on AD preferred 3-5 years industry/ clinical research / related experience in a scientific… more
- Merck & Co. (North Wales, PA)
- …and expertise in data and data standards across Clinical Development, Medical Affairs , and Regulatory Affairs domains. Apply domain knowledge to ... Job DescriptionThe Business and Information Architecture (BIA) group within our Research & Development Division's Clinical Development and Digital Solutions… more
- Eisai, Inc (Nutley, NJ)
- …in the United States.Provide input to the health economics and outcomes research strategies, and timelines with medical affairs , marketing, managed markets ... is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines,… more
- Insmed Incorporated (San Diego, CA)
- …collaborate closely with the Biometrics teams, Clinical Operations teams, Clinical Development teams, Regulatory Affairs , and external ... technical expertise and system documentationEnsure data integrity, system reliability, and regulatory compliance across all phases of clinical developmentTeam… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to develop CDx ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary:The primary… more
- Merck & Co. (North Wales, PA)
- …a product currently under review by the FDA, and an active research pipeline.We are currently recruiting for a results-driven and strategic Director, Product ... the enterprise including Sales, Global Marketing, Data & Analytics, Medical Affairs , Policy, Payer Marketing, Finance, Manufacturing, L&D, Global Communications, … more
- Merck & Co. (Rahway, NJ)
- …Large Molecule Assay Validation, Quality Assurance, Technical Operations, and CMC Regulatory Affairs , to address technical challenges, provide scientifically ... to join our Rahway, NJ team as a Scientist (R2) in Biologics Analytical Research & Development (AR&D) GMP Operations, to support ELISA and cell-based methods. In… more
- Merck & Co. (Rahway, NJ)
- …Development, External Capabilities, Quality Assurance, Technical Operations, and CMC Regulatory Affairs , to address technical challenges, provide scientifically ... to join our Rahway, NJ team as a Scientist (R2) in Biologics Analytical Research & Development (AR&D) GMP Operations, to support separations methods (eg HPLC, UPLC,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(eg SOPs) as appropriate.Collaborate with cross-functional teams (eg, Medical Safety, Regulatory Affairs , Epidemiology) to ensure benefit-risk integration to ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: This is… more
- Nura Bio (South San Francisco, CA)
- … regulatory guidance and support to cross-functional teams, including research and development, clinical , manufacturing, and quality assurance. *Monitor ... central, peripheral, and ocular nervous system. The VP/Head of Regulatory Affairs will be a key member...Affairs will be a key member of our clinical leadership team, responsible for developing and executing … more
- Kenai Therapeutics (San Diego, CA)
- …Collaboration: Lead and collaborate with other functional areas, including Regulatory Affairs , Medical Affairs , Biometrics, and Research , to ensure ... clinical trials, with a focus on meeting project milestones, timelines, and regulatory requirements. The VP of Clinical Operations will collaborate closely… more
