- 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 ... range of audiences, including executive leadership, development partners, and global regulatory agencies. This role will include global development leadership of one… more
- Bristol Myers Squibb (Brisbane, CA)
- …we are inspired by a single vision - transforming patients' lives through science . In oncology, hematology, cell therapy, immunology and cardiovascular disease - and ... institutes best practices with regards to planning, execution, interpretation and regulatory submission of clinical projects and studies. Provides guidance and… more
- AbbVie (South San Francisco, CA)
- …related to output design and programming conventions. Responsible for monitoring regulatory guidance and industry best practices. *Case report forms and database ... activities for 4-10 statistical programmers Qualifications + MS in Statistics, Computer Science or a related field with 10+ years of relevant experience. OR… more
- Stanford University (Stanford, CA)
- …Health and Wellness (PMHW) within the Department of Psychiatry & Behavioral Science is focused on developing precision medicine approaches for mental health spanning ... "Neuroscience is Personal." Our ethos is collaborative and one that believes quality science goes hand in hand with mutual respect (More information on our lab… more
- Abbott (Pleasanton, CA)
- …will collaborate cross-functionally with development, product, operations, quality, and regulatory teams to ensure the delivery of high-quality, compliant software ... Ensure all test strategies and practices align with medical device regulatory standards (FDA, ISO, IEC 62304).Support documentation, verification, and validation… more
- Takeda Pharmaceuticals (Los Angeles, CA)
- …for Teardown, Fractionation, and Purification following cGMP, GDDP, FDA and Regulatory Standards, ISO requirements, and internal standard operating procedures. The ... practices. Provide assessments to support good understanding and knowledge of current regulatory requirements ie, FDA, ISO, and Takeda Quality Systems, and serve as… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Performs a wide variety of activities to ensure compliance with applicable regulatory requirements as part of a QA team supporting Gilead's global logistics ... Planning, Warehouse, Customer Service personnel as well as Trade Operations, Regulatory Affairs and Validation/Packaging Engineering. + Interfaces with and provides… more
- Mentor Technical Group (Millbrae, CA)
- …and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure ... to develop others through coaching and facilitation. + Maintain internal and regulatory reporting including data collection and reporting including but not limited… more
- AbbVie (Pleasanton, CA)
- …to provide leadership on the use of Quality Engineering methodologies, tools, regulatory compliance requirements. + Ensure that technical information is accurate and ... in compliance with quality and regulatory requirements. + Review Design Changes post design transfer....Qualifications Education & Experience Must possess Bachelor's degree in Science , Engineering, or a related field (or foreign equivalent)… more
- AbbVie (Irvine, CA)
- …must effectively interface with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Development Operations. Responsibilities + Leads the ... individual studies and integrated data. + Creates documentation for regulatory filings including reviewers guides and data definition documents....days / week* Qualifications + MS in Statistics, Computer Science or a related field with 9+ years of… more