- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Writing is a key role responsible for producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. ... This position requires collaboration across various functions to meet aggressive timelines. Clinical regulatory documents include, but are not limited to, … 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 ... and immune disorders. Summary: Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … 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
- Insmed Incorporated (San Diego, CA)
- … studies, review & interpretation of clinical trial data, authoring clinical study and regulatory communications and documents, and monitoring of competitor ... clinical development team, partnering closely with heads of clinical operations, toxicology, regulatory affairs, commercial, pharmacovigilance, clinical… 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 ... 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
- Insmed Incorporated (San Diego, CA)
- …The Senior CRS will provide clinical and scientific support to clinical development and operations, regulatory , medical affairs, drug safety, and quality ... Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Senior Clinical Research Scientist (CRS) will support and work predominately with the… more
- Merck & Co. (North Wales, PA)
- …accuracy and integrity.-Collaborate with other departments: Collaborate with departments such as clinical , regulatory , and safety to ensure that PV processes are ... and Clinical practices, Computer Systems Validation, and other global regulatory requirements that impact IT systems in the R&D and manufacturing… 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 ... IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated bioanalytical data.… 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)
- …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 ... 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with CDP and aligned to achieve the Target Product Profile (TPP)Development of clinical sections of trial-level regulatory documents (eg, response to HAs, ... Director, Clinical Development Join a Legacy of Innovation 125...of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and… 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 ... Budgeting and Outsourcing. This position requires strong collaboration with stakeholders across Clinical Medical and Regulatory (CMR), including the NACO senior… 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 technical training across all CMR functions, and compliance across clinical development, medical, and regulatory roles/processes/SOPs Develop and implement… more
- Merck & Co. (North Wales, PA)
- …for managing any study specific partners and/or vendors.Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to ... This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the… more
- Merck & Co. (Rockville, MD)
- …overall company position to respond to upcoming legislation, guidance, and regulatory processes applying to clinical evidence development.-Working closely with ... clinical research policy goals.Working closely with the Global Regulatory Policy team to align on clinical ...Global Regulatory Policy team to align on clinical research policy efforts in the regions and therapeutic… 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 ... number of stakeholders across CDSE and more broadly within Clinical , Medical and Regulatory , Market Access and Public Affairs. Externally, this individual is… more
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