- Gilead Sciences, Inc. (Foster City, CA)
- …ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. **EXAMPLE RESPONSIBILITIES:** + As needed, represents ... regulatory strategies, processes, standards, practices, efficiencies and capabilities. + Represents Regulatory Affairs and may serve as Regional Lead or… more
- Amgen (Thousand Oaks, CA)
- …and phases. This AVP will collaborate closely with cross-functional teams including clinical operations, biostatistics, regulatory affairs , and quality to ... in clinical data management. + Cross-functional collaboration experience with clinical operations, regulatory affairs , biostatistics, and R&D teams.… more
- UCLA Fielding School of Public Health (Los Angeles, CA)
- …and knowledge of FDA regulatory pathways. * ACRP certification, expertise in regulatory affairs and regulatory submissions, IND filings, engagement with ... Associate Director of Clinical Theranostics Research,... regulatory pathways. * ACRP certification, expertise in regulatory affairs and regulatory submissions,… more
- Abbott (Alameda, CA)
- …priorities, and to be flexible when priorities change. + Working knowledge of GCP, Clinical and Regulatory Affairs . + Proficient with Microsoft Suite. ... more than 160 countries. **The Opportunity:** The CRA II will assist in the clinical execution and management of all aspects of assigned clinical studies. This… more
- Ascendis Pharma (Palo Alto, CA)
- …serve as a clinical research resource for-cross-functional colleagues (eg in clinical operations, statistics, regulatory affairs , medical affairs , ... strategy + Contribute to drafting and reviewing of clinical documents, manuscripts, presentations, and regulatory submissions...Those with less experience may be considered for an Associate Medical Director position. + At least 3 years… more
- AbbVie (San Francisco, CA)
- …programs under consideration. + Reviews and provides clinical operations content to clinical and regulatory documents (eg, INDs, IB, NDAs, BLAs, MAA, ... YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Clinical Operations Program Director is responsible to connect science and… more
- Bristol Myers Squibb (Brisbane, CA)
- …(Masters, PhD, PharmD, BSN, etc.) with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry. **Key Competency Requirements** ... and in their personal lives. Read more: careers.bms.com/working-with-us . ** Associate Director, Global Regulatory Strategy, Neuroscience** **Position Summary:**… more
- Edwards Lifesciences (Santa Ana, CA)
- …assigned Regional Director and will collaborate with multiple departments including Sales, Clinical Affairs , Marketing, Quality, Regulatory , and Education. ... and Surgery. **What you will need (Required):** + An associate 's or equivalent two (2) year clinical degree in Life Sciences or related field or equivalent… more
- Gilead Sciences, Inc. (Foster City, CA)
- …trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development Operations functions, ensures that ... and commercialization of Gilead's products. **Key Responsibilities:** + In partnership with Clinical Program Manager or Associate Director, provides guidance and… more
- J&J Family of Companies (Irvine, CA)
- … clinical landscapes, and a thorough understanding of publication standards, regulatory guidelines, and clinical study design. **Key Responsibilities:** + ... electrophysiology congresses + Collaborate closely with internal cross-functional teams ( Clinical , Biostatistics, Medical Affairs , Global Strategic Marketing,… more