- DivIHN Integration Inc (Columbus, OH)
- …in-depth investigation of medical adverse events and works with Medical Affairs , Clinical , and Regulatory Affairs in the preparation of documentation on ... to present case data, medical and scientific data orally and in writing. Clinical Monitor or Research Coordinator Education: Associate or Bachelor's degree… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Supervise designated personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop ... About the Department The Clinical , Medical and Regulatory (CMR) department...positive rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personnel in other departments including Marketing, CMR, Legal, and counterparts in NNAS Regulatory Affairs . Has a positive approach to work projects and ... About the Department The Clinical , Medical and Regulatory (CMR) department...of 5 years' experience required (Pharmaceutical industry, laboratory, or clinical research experience) An intermediate to advanced… more
- Merck & Co. (North Wales, PA)
- …Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to ... or clinical experience, preference if this experience is in regulatory affairs .Required Experience and Skills: Regulatory experience preferred for… more
- Eisai, Inc (NJ)
- …3 years in an in-house Medical Affairs role; MD preferredClinical research experience, including conducting clinical trials in the Phase IIIb-IV ... responsible for working with key stakeholders to develop and execute the medical affairs plan, including post-marketing research , medical education, research … more
- Daiichi Sankyo, Inc. (Basking Ridge, 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 leading… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryLeadership responsibility ... for global regulatory strategy to support the development of biomarkers, companion...study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- 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.… more
- Merck & Co. (Rockville, MD)
- …with the company's Research Laboratories divisions and most directly with Global Regulatory Affairs and Clinical Safety (GRACS) to define and implement ... and Development Division's colleagues, regulatory liaison staff, and local regulatory affairs staff for submission of product applications and other related… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …include working with Headquarters, NA CMR including Clinical Trial Management, Medical Affairs , Regulatory Affairs and other NNI skill areas. External ... About the Department The Clinical , Medical and Regulatory (CMR) department...area experience in diabetes, CV or Obesity required Prior clinical research or related experience (eg monitoring… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....partner closely with teams and senior leaders from across Regulatory Affairs , as well as cross-functional stakeholders… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and ... program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic… more
- Tris Pharma (Monmouth Junction, NJ)
- …initiatives. This includes, but is not limited to: Research , Product Development, Clinical Development, Regulatory Affairs , CMC, New Products, Sales & ... evaluation; provide input on deal terms and creation of relevant clinical , regulatory , and commercial scenarios Prepare clear and concise presentations across a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 30% overnight travel required. Position can ... About the Department The Clinical , Medical and Regulatory (CMR) department...Affairs , Medical Strategy & Operations, Medical Information, Publications, Clinical Directors, HEOR Directors, Global Medical Directors, Marketing, and… more
- Merck & Co. (South San Francisco, CA)
- …reports. Interact with colleagues from multiple areas, including discovery, regulatory affairs , project teams, and development functions.Partner with ... Job DescriptionResponsibilities:Primary responsibility is writing and preparing nonclinical pharmacology regulatory document submission sections and study reports to support… more
- Aequor (NJ)
- …and inventory management of clinical supplies required to support global clinical research and development studies during phases 1-4. The individual must ... and external Customers and Service Providers, including but not limited to Clinical Research and Development, Global Study Management and Monitoring (GSMM),… more
- Eisai, Inc (Nutley, NJ)
- …including experience in the therapeutic area and 5 years in an in-house Medical Affairs role. Clinical research experience, including conducting clinical ... responsible for working with key stakeholders to develop and execute the medical affairs plan, including post-marketing research , medical education, research … more
- Arthrex (Naples, FL)
- …documents and coordinates with additional collaborators including product management, statistician, regulatory affairs , clinical research management, ... as a clinical research professional and knowledge of clinical regulatory regulations is required. Excellent communication and analytical skills, and… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …Educational Requirements: Preferred Experience: Specialized training/certification in Regulatory Affairs or Clinical Research .Other: Job Specific and ... essential to the submission, approval, and maintenance of required regulatory documents for conducting clinical research in compliance with the Federal Food… more
