- Cedars-Sinai (Los Angeles, CA)
- …plan and coordinate strategies to improve existing standard operating procedures related to regulatory Affairs including drafting SOP's and/or job aids. + May ... generates reports, and maintains research files and documentation involving the regulatory requirements for the study/ clinical trial. Other duties include,… more
- Georgetown Univerisity (Washington, DC)
- …science, life science, or related field + Minimum of 2 years of experience in regulatory affairs or clinical research + Familiarity with regulatory ... in ensuring regulatory compliance and oversight of a portfolio of clinical trials in the Center for Translational Transplant Medicine (CTTM) and the Department… more
- Weill Cornell Medical College (New York, NY)
- … research experience in a healthcare setting or a Master's degree in regulatory affairs or similar. Demonstrated knowledge and understanding of clinical ... when Hired for NYC Offices **Position Summary** Under general direction, oversees the regulatory aspects of clinical trials from start-up through study closeout.… more
- ThermoFisher Scientific (Wilmington, NC)
- …development programs and operational practices. + **Stakeholder Alignment:** Interact with Regulatory Affairs , Clinical , Quality, Pharmacovigilance and Legal ... step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel… more
- University of Pennsylvania (Philadelphia, PA)
- …and manage study data and regulatory files per GCP. + Work with Regulatory Affairs Specialist to prepare for audits, review regulatory binders, perform ... programs and resources, and much more. Posted Job Title Clinical Research Coordinator B/C Job Profile Title Clinical... regulatory files per GCP. + Work with Regulatory Affairs Specialist to prepare for audits,… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …Ph.D., Pharm. D.,M.D. or equivalent and, 8 years direct experience in Medical Research, Clinical , Regulatory Affairs or other critical areas within the ... product development and/or lifecycle management. Identifies business implications of complex regulatory and clinical issues, develops risk mitigation strategies… more
- Edwards Lifesciences (Irvine, CA)
- …Surgical Structural Heart), and other Business Unit or Corporate functions such as Regulatory Affairs , Compliance, and others. . Reviewing and advising on a ... approval processes, pathways to market (510(k), PMA, etc.), requirements for FDA -regulated clinical investigations, etc.). . Monitoring legal developments… more
- J&J Family of Companies (Titusville, NJ)
- …quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs , data management, medical writing, biostatistics, global medical ... clinical team in responding to medical and compound-related issues + Working with Regulatory Affairs and global clinical operations to respond to… more
- Cardinal Health (Helena, MT)
- …capacities, including: + Global Regulatory Strategy Development + Global Regulatory Affairs + Chemistry Manufacturing and Controls Development + Nonclinical ... and Consulting + Clinical Development and Research + Medical Writing + Regulatory Publishing + Dossier Services + Submission Authoring & Filing + Quality Review… more
- BeOne Medicines (Emeryville, CA)
- …feasibility, site selection, and regulatory readiness. + Partner with Clinical Operations, Feasibility, and Medical Affairs colleagues to integrate patient ... models that strengthen representative patient enrollment. This role collaborates across Clinical Operations, Regulatory , Development, and corporate functions to… more