- Gilead Sciences, Inc. (Foster City, CA)
- …protocols and associated documents as well as participate in meetings with regulatory authorities. In addition, the scientist will direct the implementation of ... + Write, review and coordinate biomarker plans in clinical trial protocols, regulatory documents and collaboration agreements. + Must be able to work independently… more
- Amgen (Thousand Oaks, CA)
- …longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities ... effectively applied + Represents Drug Substance Technologies as a scientific, regulatory and technical expert both internally and externally + Evaluates, resolves… more
- Bristol Myers Squibb (San Diego, CA)
- …trials and will supervise and have accountability for the clinical components of regulatory filings + Will contribute to overall strategy for specific disease / ... and Communication + Will work closely with colleagues in BMS Research, Development, Regulatory , Medical, Commercial and other key functional areas on a global basis;… more
- Gilead Sciences, Inc. (Foster City, CA)
- …regarding audit outcomes and CAPAs. Beyond auditing, this role supports regulatory inspections, readiness, and partners with the R&D Quality Extended Leadership ... helping deliver life-saving therapies for unmet needs. We bring our passion for science , discovery, and creative thinking into everything we do. We are an inclusive… more
- Gilead Sciences, Inc. (Foster City, CA)
- … degree such as MS, MD, OR + 8+ years of relevant experience and a PharmD, PhD , in science or related fields OR + 8+ years of relevant experience and advanced ... Biological Product Deviation and Complaints. + Contribute to Review Regulatory Submissions (IND, IMPD, BLA, NDA, MAA), and assist...years of relevant experience and a Bachelors degree in science or related fields; OR + 10+ years of… more
- Amgen (South San Francisco, CA)
- …longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities ... with Discovery Research, Clinical Pharmacology, Toxicology, Early Development, and Regulatory Affairs teams to ensure seamless progression from IND-enabling… more
- Merck (South San Francisco, CA)
- …point in the drug development process, working closely with scientific, regulatory , statistical, and modelling colleagues across the organization to translate the ... benchtop science of preclinical discovery into compounds ready for assessment...(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations) + Provide… more
- Gilead Sciences, Inc. (Foster City, CA)
- …**,** **AI & Optimization** , you will report to the Senior Director, Data Science - AI & Optimization. Based in either Parsippany, NJ or Foster City, CA, ... as marketing, sales, and strategy across G9 countries while ensuring alignment with regulatory frameworks (eg, EU AI Act) and ethical standards. You will also… more
- Merck (San Francisco, CA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... to individual contributors + Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics and authoring … more
- PDS Defense (Seal Beach, CA)
- …documents certification and test results to substantiate for customers and regulatory agencies that requirements are satisfied. Supports in-service products by ... responses to customer inquiries, service bulletin development, failure investigation, regulatory agency coordination and to show compliance with regulatory… more