- Stanford Health Care (Palo Alto, CA)
- …Ordering, Furnishing or Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA - approved indication (off-label ... collaboration between providers and coordination of community resources. + Ensures compliance with legal, regulatory and clinical policies and procedures. +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …development from early development to commercial launch, filing experience with FDA /EMA, and in-depth technology understanding for biological products are the key ... control strategies for biologics products. + Well versed in FDA and ICH guidelines relating to registration, quality, and... and ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug product. + Proven… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Manage and maintain budget and accruals process for HCV. + Ensure compliance with all applicable laws, regulations, and regulatory guidelines governing commercial ... relationships + Understanding of the pharmaceutical payer marketing that includes FDA regulatory and legal environment (PIE, FDAMA-114, etc.) + Proven… more
- Stanford Health Care (Palo Alto, CA)
- …Furnishing or Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA -approved indication (off-label use) ... collaboration between providers and coordination of community resources. + Ensures compliance with legal, regulatory and clinical policies and procedures. +… more
- Medtronic (Los Angeles, CA)
- …as assigned/requested by management + All activities must be performed in compliance with the Quality System + Travel requirement (international possible): 20-40% ... in the operating room, so healthcare/surgical setting experience + Familiarity with FDA product requirements and regulatory guidelines + Experience with robotics or… more
- Abbott (San Diego, CA)
- …identified, obtained, and effectively presented for product registration worldwide (US, FDA , CE-IVDR, PMDA, etc.). **Strategic Planning:** + Identify and approve new ... guidance on regulatory requirements to development teams. + Manage preapproval compliance activities. + Formulate company procedures to respond to regulatory… more
- Stanford Health Care (Palo Alto, CA)
- …Furnishing or Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA -approved indication (off-label use) ... collaboration between providers and coordination of community resources. + Ensures compliance with legal, regulatory and clinical policies and procedures. +… more
- UCLA Fielding School of Public Health (Los Angeles, CA)
- …facilities for the production of clinical and preclinical PET biomarkers in compliance with internal procedures, cGMP, other FDA regulations and United ... students the fundamentals of clinical grade radiolabeled biomarker production and FDA compliant procedures and operations. Interested candidates should submit their… more
- Stanford Health Care (Palo Alto, CA)
- …Furnishing or Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA -approved indication (off-label use) ... collaboration between providers and coordination of community resources. + Ensures compliance with legal, regulatory and clinical policies and procedures. +… more
- J&J Family of Companies (Santa Clara, CA)
- …**Essential Job Functions** + Design, develop, and root cause product(s) in full compliance with the company's Design Control requirements and consistent with FDA ... Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations + Other duties as assigned **Requirements** + Bachelor's degree… more