- 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
- 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
- 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. (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
- 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)
- …content, etc.). Collaborate with other stakeholders across Global & US Medical Affairs functions and other regions in addition Clinical Development, ... 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
- 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. (Durham, NC)
- …and effectiveness Regulatory Acumen and effective working relationship with Global Regulatory Affairs and Clinical Safety (GRACS) Demonstrated conflict ... materials or managing a portfolio of complex process changes with regulatory impact Responsibilities Business Case Development Understanding the requirements of a… more
- Merck & Co. (North Wales, PA)
- …and data protection matters across company operations, including with respect to research and development (eg, clinical trials, informed consent), US commercial ... Research , Legal Strategies, Negotiation, Pharmaceutical Law, Regulation Enforcement, Regulatory Compliance, Team Play-Preferred Skills:Data Privacy, General Data Protection… 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
- 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
- University of Pennsylvania (Philadelphia, PA)
- …wealth of health and wellness programs and resources, and much more. Posted Job Title Clinical Research Regulatory Affairs Specialist Job Profile Title ... Clinical Research Regulatory Specialist B Job Description Summary ...Penn), regulatory bodies (both internal and external) and research participants. Regulatory Affairs staff… more
- RWJBarnabas Health (West Orange, NJ)
- Senior Counsel, Assistant Vice President of Legal Affairs , Clinical Research & Regulatory ComplianceReq #:0000206242 Category:Legal, Risk and Compliance ... Senior Counsel / Assistant Vice President of Legal Affairs , Clinical Research & Regulatory Compliance Job Overview: RWJBarnabas Health, New Jersey… more
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