- Abbott (Pleasanton, CA)
- …and issues. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, and ... and issues. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, and… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …& Risk Management** + Ensure all training programs meet global regulatory standards ( FDA , EMA, ICH, etc.) and internal SOPs. + Monitor training compliance metrics ... + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to design and deliver impactful learning programs… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …use, and clinical performance criteria. + Ensure compliance with design control processes per FDA 21 CFR Part 820, ISO 13485, and IVDR. + Lead risk management ... + Strong knowledge of design control, risk management, and regulatory standards ( FDA , ISO, IVDR). + Experience in companion diagnostics, flow cytometry or clinical… more
- Bayer (Bakersfield, CA)
- …Medical Inquires in collaboration with Medical Communications; + Adherence to SOP and FDA guidance for distribution of scientific information; + Adherence to SOP and ... Pharmacy, Medicine, Nursing or equivalent experience is preferred; + Working knowledge of FDA , OIG requirements; + A minimum of 1 year MSL experience or 2… more
- System One (Walnut Creek, CA)
- …that all study activities are performed in compliance with ICH-GCP, FDA , and institutional standards, prioritizing participant safety, data integrity, and regulatory ... or Sub-Investigator in clinical research. + Strong understanding of ICH-GCP, FDA regulations, and clinical research ethics. + Proven leadership in managing… more
- BeOne Medicines (San Mateo, CA)
- …authorities to deal with Logistics issues as needed, for example, Customs and FDA . + Coordinate internal or external functions for the Import and export permit ... export activities, participate in logistics audits as needed. + Support SCL on FDA inspection, internal audit and external audit as needed on logistics data… more
- 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 ... use) require a patient-specific order in advance from the supervising physician. + 10. After appropriate training, assists the supervising physician in the operating room (OR). + a. Acts as first or second assistant under the supervision of an approved… more
- Cytel (Sacramento, CA)
- …+ Maintain strong engagement with senior client leadership, regulatory agencies ( FDA /EMA), and key opinion leaders to support and refine development strategies. ... driving high-impact consulting engagements. + Experience interacting with regulatory agencies ( FDA /EMA) and key opinion leaders to shape and enhance development… more
- Cedars-Sinai (Beverly Hills, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). Primary Duties and Responsibilities + ... with all federal and local agencies including the Food and Drug Administration ( FDA and local Institutional Review Board. + Maintains research practices using Good… 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) ... require a patient-specific order in advance from the supervising physician. + After appropriate training, assists the supervising physician in the operating room. The RN First Assistant directly assists the surgeon and practices under the supervision of the… more