- Boehringer Ingelheim (Ridgefield, CT)
- …will also provide US strategic regulatory guidance to facilitate efficient and compliant drug development and product maintenance as well as act as primary company ... liaison with the US Food and Drug Administration. This role will primarily be focused in the therapeutic area of Cardio Renal Metabolic. (CRM). + Provide analysis,… more
- Sanofi Group (Morristown, NJ)
- …other medical and clinical scientific experts, clinical development scientists, in the project in collaboration with the Global safety Officer, Regulatory ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...focused medical and scientific expertise to the cross functional project team to conduct the clinical studies from early… more
- Edgewell Personal Care (Allendale, NJ)
- …and NAFTA is desired. + Knowledge of global regulatory framework for consumer safety and pharmacovigilance . + Proven ability to communicate, influence and ... (FDA, Health Canada, TGA, and ICH guidance, EU Directives, Consumer Product Safety Laws, etc.) to assure adherence to all requirements. + Maintains thorough… more
- Nestle (Bridgewater, NJ)
- …Deep understanding of biotech/pharmaceutical manufacturing systems and processes supporting drug safety , pharmacovigilance , manufacturing, engineering ... new GxP systems to support NHSc product portfolio. + Serve as Project Manager for technology implementations, including coordination and management of external… more
- University of Pennsylvania (Philadelphia, PA)
- …of research in cancer centers. Additional experience in clinical research ie Data Management, Project Management, Drug Safety are a strong plus. The ... Play a vital role in performing quality reviews of pharmacovigilance data that are evaluated and acted on by...evaluated and acted on by the ACC Data and Safety Monitoring Committee. + Strictly adhere to all ACC… more
- ThermoFisher Scientific (Carlsbad, CA)
- …presents sponsor meetings, provides medicines and device development consultation to clients and project team members in direct support of sales efforts. + Serves as ... effectively with key internal directorates including Operations, Biometrics, Regulatory, Pharmacovigilance , and Global Product Development to ensure the best… more
- AbbVie (South San Francisco, CA)
- …AbbVie's customers, markets, business operations, and emerging issues. Oversees project -related education of investigators, study site personnel, and AbbVie study ... integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is… more
- AbbVie (North Chicago, IL)
- …AbbVie's customers, markets, business operations and emerging issues. Oversees project -related education of investigators, study site personnel and AbbVie study ... integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is… more
- AbbVie (Irvine, CA)
- …AbbVie's customers, markets, business operations and emerging issues. Oversee project -related training of investigators, study site personnel, and AbbVie study ... interpretation, and communication of accumulating data pertaining to botulinum toxin safety and efficacy in aesthetic indications. Along with Clinical Operations,… more
- AbbVie (Irvine, CA)
- …AbbVie's customers, markets, business operations, and emerging issues. Oversee project -related training of investigators, study site personnel, and AbbVie study ... interpretation, and communication of accumulating data pertaining to botulinum toxin safety and efficacy in varied indications. Along with Clinical Operations,… more