- Sanofi Group (Morristown, NJ)
- …endpoint strategy implementation + Knowledge of the drug development process and the regulatory ( FDA , EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G-BA, ... **Job Title:** Clinical Outcome Assessment (COA) Lead **Grade:** L3 **Hiring...instruments; the development of briefing books or dossiers for regulatory consideration of COAs Internal customers include primarily Research… more
- University of Pennsylvania (Philadelphia, PA)
- …safety, protocol compliance and data quality. Adhere to all University of Pennsylvania, FDA and GCP guidelines. Clinical Research Coordinator B is expected to ... and wellness programs and resources, and much more. Posted Job Title Clinical Research Coordinator A/B (Department of Rheumatology) Job Profile Title Clinical… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures. The Clinical Research ... The Clinical Research Scientist leads the execution of the...site selection activities + Serves as G lobal Medical Affairs point of contact with external resources and contacts… more
- University of Pennsylvania (Philadelphia, PA)
- …of Phase I-IV clinical trials (10% Essential: 1),Prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all other applicable ... programs and resources, and much more. Posted Job Title Clinical Research Coordinator C (Department of Neurosurgery) Job Profile...to implement a plan of action. Work with the regulatory manager to ensure that submissions to the IRB… more
- Novo Nordisk (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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing...The Position The position serves as the lead of Clinical Data Science & Evidence (CDSE) operations. In their… more
- Novo Nordisk (Plainsboro, NJ)
- …job-specific training curricula for different roles within clinical operations, medical affairs , and regulatory affairs + Maintain training assignments ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing...field + 7+ years of experience in pharmaceutical training, clinical research, or regulatory affairs … more
- J&J Family of Companies (Santa Clara, CA)
- …team that will serve as a two-way scientific exchange resource to internal (ie Clinical Affairs , Medical Affairs , Biostats, Marketing, R&D etc.) and external ... etc. + Establish and maintain strong internal cross-functional (ie Clinical Affairs , Medical Affairs , Biostats,...including study protocols, case report forms, instructions for use, clinical study reports, and regulatory submissions. +… more
- J&J Family of Companies (Raritan, NJ)
- …+ May act as medical contact at company for worldwide health authorities concerning clinical /medical issues + Assists Regulatory Affairs in the development ... matrix interactions also includes individuals from project management, operations, regulatory affairs , data management, medical writing, biostatistics,… more
- Terumo Medical Corporation (Somerset, NJ)
- …and scientific support for the organization that includes Medical Affairs , Clinical Operations, Sales, Marketing, Regulatory Affairs , to ensure maximum ... and external stakeholders. + Build relationships and demonstrate the clinical outcome and benefits of company products to Key...+ Regulatory activities partnership: + Work with regulatory affairs to ensure that all written… more
- Ascendis Pharma (Princeton, NJ)
- …programs, competitive landscape, new therapies, clinical trends, and newly issued regulatory rules and FDA guidance to promptly identify any potential impact ... advocacy groups. + Work with internal stakeholders including Commercial, Legal, Regulatory , Clinical Development, Clinical Operations, Compliance,… more