- Stanford Health Care (Palo Alto, CA)
- …has been in treating B-cell lymphoma, where CAR T-cell therapy has become an FDA -approved standard of care. We are now expanding our efforts to develop cell ... 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… more
- Ascendis Pharma (Palo Alto, CA)
- …our core values of Patients, Science, and Passion, we use our TransCon(R) drug development platform to fulfill our mission of developing new and potentially ... direction of Head of GPS Medical Science, is responsible for all assigned Ascendis Drug Safety PV related activities for all products in the Ascendis portfolio. This… more
- AbbVie (Irvine, CA)
- …R&D organization in navigating enterprise-critical issues in an evolving legal and regulatory environment as we work to bring new, innovative products to patients. ... leaders within the R&D and corporate strategy organizations on legal and regulatory issues that impact pipeline development, government agency engagement and product… more
- Cedars-Sinai (Los Angeles, CA)
- …Ensures compliance with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **What are ... quality and study conduct. + Works closely with a regulatory coordinator or directly with the Institutional Review Board...all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review… more
- Cedars-Sinai (CA)
- …Ensures compliance with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). Primary ... data quality and study conduct. Works closely with a regulatory coordinator or directly with the Institutional Review Board...all federal and local agencies including the Food and Drug Administration ( FDA and local Institutional Review… more
- Cedars-Sinai (Beverly Hills, CA)
- …Ensures compliance with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **What are ... quality and study conduct. + Works closely with a regulatory coordinator or directly with the Institutional Review Board...all federal and local agencies including the Food and Drug Administration ( FDA and local Institutional Review… more
- Cedars-Sinai (Los Angeles, CA)
- …*Ensures compliance with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. Maintains research ... field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to a growing array of minimally invasive procedures,… more
- Cedars-Sinai (Los Angeles, CA)
- …Ensures compliance with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). Primary ... quality and study conduct. + Works closely with a regulatory coordinator or directly with the Institutional Review Board...all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review… more
- Gilead Sciences, Inc. (Foster City, CA)
- …knowledge of the drug development process and GVP, including global regulations ( FDA , EMA, ICH) and their application to cross-functional drug development. + ... regarding audit outcomes and CAPAs. Beyond auditing, this role supports regulatory inspections, readiness, and partners with the R&D Quality Extended Leadership… more
- Gilead Sciences, Inc. (Foster City, CA)
- …the drug development process and GCP, including global regulations ( FDA , EMA, ICH) and their application to cross-functional clinical development. + Proficient ... improvements in R&D quality processes, systems, and standards to meet regulatory requirements and organizational goals and contribute to the overall quality… more
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