- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a key member of the Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other ... as other research areas centered around rare diseases and immune disorders.SummaryThe Director, Clinical Safety, will be a product safety lead or part of a product… 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 ... of those most recent years working as an employee in clinical , medical and/or regulatory in the pharmaceutical industry (Pharma/Biotech/CRO) A minimum of 7 years… more
- Merck & Co. (Rahway, NJ)
- …mentorship to other clinical scientists. Core Skills Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple ... DescriptionThis position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have… 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 ... least 5 of those most recent years working as an employee in clinical , medical and/or regulatory in the pharmaceutical industry (Pharma/Biotech/CRO) Experience… more
- Formation Bio (New York, NY)
- …throughout the trial process. Maintain up-to-date knowledge of industry trends, regulatory requirements, and emerging best practices in clinical trial ... conducted in accordance with ICH-GCP guidelines, FDA regulations, and other applicable regulatory requirements. Ensure that clinical trials are conducted to the… 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 ... Development. Internal relationships include working with Headquarters, NA CMR including Clinical Trial Management, Medical Affairs, Regulatory Affairs and other… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … 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 ... will interface with key stakeholders across Novo Nordisk Inc (NNI) including Clinical Development, Medical, & Regulatory Affairs (CMR), Commercial Strategy &… more
- Insmed Incorporated (San Diego, CA)
- …expertise with global counterparts in other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, ... experience preferred. Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/ submissions involving safety… more
- Formation Bio (New York, NY)
- …regulatory strategies, and ensuring high-quality statistical contributions across clinical development. They will also collaborate cross-functionally to integrate ... approaches, and AI/ML applications to enhance efficiency and decision-making. Guide clinical and regulatory strategies to optimize trial design and… more
- Merck & Co. (Rahway, NJ)
- …on ClinicalTrials.gov or EudraCT.Experience in authoring International Council for Harmonization clinical / regulatory documents (ie, Clinical Study Reports, ... clinical research documents preferred.Experience in medical publications or regulatory product labeling.Preferred Experience and Skills: Good communication and… more
- Merck & Co. (Rahway, NJ)
- …to ensure full integration of the device development activities with the clinical , regulatory , formulation, commercial and other key Ofunctions.Lead the Device ... products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional… more
- Genmab (Plainsboro, NJ)
- …to regulatory requirements for programs and products. Participate in regulatory sub-team, clinical management team, and labeling working group meetings, ... and project teams Prepare/oversee/review/maintain regulatory documentation (eg regulatory sections of clinical applications, marketing applications, Health… more
- Genmab (Plainsboro, NJ)
- …Lead creation and review of clinical components of key documents, clinical and regulatory documents, annual safety updates, and registration dossiers (ie, ... protocol, ICF, IB, annual safety updates, study reports, regulatory submissions [Briefing documents, IND, Clinical dossiers] supporting registration, market… more
- Merck & Co. (North Wales, PA)
- …the enterprise including Medical Affairs, Outcomes Research, Global Marketing, Clinical , Regulatory , Legal/Compliance to ensure coordination and consistency ... executionServe as the subject matter expert for the therapeutic category and clinical landscapeRepresent US commercial perspective on V&I team, and Regional Medical… more
- Genmab (Plainsboro, NJ)
- …healthcare market through collaboration with US Commercialization, Global Medical Affairs, Clinical Development, Regulatory , and other cross functional teams.We ... regional strategies and tactics with appropriate use of resources.Work with clinical development, regulatory , commercial, and market access teams to… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
