- Gilead Sciences, Inc. (Foster City, CA)
- …CROs to assure high quality and timely delivery of written PK reports and regulatory documents (IND, IMPD, IB, BLA) for regulatory submissions. + Supervising of ... and 12 Years' Experience OR Masters' Degree and 10 Years' Experience OR PhD and 8 Years' Experience **Preferred Qualifications:** + Requires a highly motivated… more
- Sharp HealthCare (San Diego, CA)
- …performing administrative tasks to meet the goals of quality, safety and regulatory requirements. This position may require travel to other Sharp HealthCare ... program and record keeping techniques for on-going quality assurance and regulatory agency review.Responsible for inspecting and implementing all provisions and… more
- Alexandria Real Estate Equities, Inc (San Francisco, CA)
- …to various disease and therapeutic areas, capital markets, US healthcare and regulatory activities, and broader trends in the life science and adjacent industries. ... degree in a life science-related field required. Master's or PhD a plus. + Minimum 7 years' prior work...fundamentals, the drug development process, the US healthcare and regulatory landscape, venture and equity financing, and human disease.… more
- General Atomics (Poway, CA)
- …**Job Qualifications:** + Typically requires a bachelors degree, masters degree or PhD in engineering or a related technical discipline from an accredited ... masters degree, or four or more years with a PhD . May substitute equivalent engineering experience in lieu of...required diagnostics, tools and equipment, while ensuring safety and regulatory compliance. + Must have a general understanding of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Medical Affairs, US Commercial, US Government Affairs and Policy, US Public Affairs, US Regulatory , and US legal and compliance + Represent US data gaps and research ... talent development. **Basic Qualifications** + MD, DO, PharmD, or PhD in life sciences degree with 14+ years of...needs. + Must be fully cognizant and adhere to regulatory and legal (Business Conduct) requirements for US Medical… more
- General Atomics (San Diego, CA)
- …Interface with the Reactor Design Modeling team to ensure designs meet regulatory and licensing requirements. + Documents findings and communicates reports and ... Company as a technical contact to customers and/or government regulatory agencies. + Coordinate segments of a project and...+ Typically requires a bachelors degree, masters degree or PhD in engineering or a related technical discipline from… more
- Bristol Myers Squibb (San Diego, CA)
- …statistical deliverables and alignment with program goals. + Partner with clinical, regulatory , and medical teams to shape development strategies, trial designs, and ... lifecycle plans that optimize clinical outcomes and regulatory success. + Oversee statistical design, endpoint selection, DMC...strategy and execution. **Qualifications & Experience** + MS or PhD in Statistics or Biostatistics + 12+ years of… more
- J&J Family of Companies (Irvine, CA)
- …and cross-functional partners (eg Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc), contributing ... to business plans; . Supports clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the...least 6 years, MS with at least 5 years, PhD with at least 3 years of relevant experience… more
- Pfizer (South San Francisco, CA)
- …investigator brochures, clinical study reports, statistical analysis plan, and regulatory documents. + Provide leadership to early stage clinical scientists ... with other clinicians, statisticians, clinical pharmacologists, translational biologists and regulatory specialists. Meet regularly with the Pfizer Oncology group… more
- Medtronic (Northridge, CA)
- …concise, and well-structured test plans and reports to support regulatory submissions. This role involves coordinating required chemical characterization testing, ... and authoring clear, concise, and well-structured reports to support regulatory submissions. This position involves close collaboration with multidisciplinary and… more