- Gilead Sciences, Inc. (Santa Monica, CA)
- …Collaboration and Compliance** + Partner across Kite Medical Affairs , Clinical Development, Translational Medicine, Regulatory Affairs , and Product ... experience in the biopharmaceutical industry, with at least 5 years in medical affairs , clinical development, or evidence generation roles. + Proven leadership… more
- University of Pennsylvania (Philadelphia, PA)
- …and responsibilities of sponsors, vendors, clinical researchers, and government officials. Regulatory Affairs Specialist C will lead the coordination of unit ... research, including but not limited to Phase I-IV clinical trials. The Regulatory Affairs Specialist C will, independently prepare and process all … more
- University of Pennsylvania (Philadelphia, PA)
- …programs and resources, and much more. Posted Job Title Regulatory Affairs Specialist-CC Job Profile Title Clinical Research Regulatory Specialist ... the coordination of Phase I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager, the Regulatory Affairs Specialist-CC will,… more
- Abbott (Pleasanton, CA)
- …Failure. We have an exciting opportunity for a seasoned leader to join our Global Clinical and Regulatory Affairs team within the Heart Failure Division ... budget and resources) by working closely with internal stakeholders (R&D, Marketing, Clinical Affairs , Regulatory Affairs , Medical Affairs ,… more
- Organon & Co. (Jersey City, NJ)
- …strategy. Additionally, cross-functional interactions with early clinical development, late- clinical development, regulatory affairs , safety and ... regulators, scientific leaders, and physicians, as needed. + Oversight and/or review non- clinical CTD modules, briefing books, or other regulatory communications… more
- Dentsply Sirona (Charlotte, NC)
- …in dentistry, research and/or clinical studies. + 3+ years prior experience in clinical affairs , regulatory affairs , and/or clinical research ... clinical study documentation to Independent Ethics Committees/Review Boards and Regulatory Authorities. + Registration of clinical studies in applicable… more
- J&J Family of Companies (Danvers, MA)
- … Clinical Research Scientist will oversee clinical studies within the Clinical and Regulatory Affairs department. The ideal candidate will be ... Leadership, Medicines and Device Development and Regulation, Presentation Design, Regulatory Affairs Management, Relationship Building, Research Documents,… more
- Organon & Co. (Plymouth Meeting, PA)
- …work collaboratively with cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing ... Investigator Brochures, briefing books, IND subsections, submission modules and other regulatory documents. + Provide clinical pharmacology subject matter… more
- University of Pennsylvania (Philadelphia, PA)
- …With the oversight of the Director, the Associate Director for Regulatory Affairs will oversee the portfolio of clinical research undertaken within the ... the Director, the Associate Director for Regulatory Affairs will oversee the portfolio of clinical ...the primary point of authority for the Physician-Investigators and clinical research staff on regulatory affairs… more
- Abbott (Alameda, CA)
- …study site staff, and clinical management. + Working knowledge of CFR, ICH-GCP, Clinical and Regulatory Affairs + Proficient with Microsoft Suite **What ... scientists. **The Opportunity** The CRA will ensure quality, accuracy, and integrity of clinical trial data throughout the full lifecycle of multiple clinical … more