- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be responsible ... and follow-up of internal and external audits to ensure compliance with regulatory requirements. + ** Regulatory Authority Engagement:** Act as the primary… more
- ThermoFisher Scientific (San Diego, CA)
- …stability programs with high complexity for development stage pharmaceutical compounds ( drug substances and drug products). Reviews stability protocols, reports, ... (CSOs). Supports shelf-life/retest dating, data trending, and specification revision for drug substances and drug products. Coordinates internal stability… more
- Pfizer (South San Francisco, CA)
- …clinical study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. + Foster a transparent environment that builds strong ... external partners, such as project leaders, research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, translational oncology, precision… more
- Amgen (Thousand Oaks, CA)
- …pre-clinical toxicology approaches + Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory ... scientific strategy and planning and execution for all aspects of clinical drug development across Amgen's clinical programs. This Executive Director within Clinical… more
- Biomat USA, Inc. (Bakersfield, CA)
- …and compliance with all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety ... activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts as a… 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 ... and coordination of community resources. + Ensures compliance with legal, regulatory and clinical policies and procedures. + Participates in quality improvement… more
- Fujifilm (Sacramento, CA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... skills, self-starter a must along with ability to maintain paperwork to FDA and company required standards. + Excellent analytical and communication skills with… more
- Stanford Health Care (Redwood City, 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 ... of community resources. + 16. Ensures compliance with legal, regulatory and clinical policies and procedures. + 17. Participates...+ BLS - Basic Life Support + DEA - Drug Enforcement Administration **These principles apply to ALL employees:**… 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) ... and coordination of community resources. + Ensures compliance with legal, regulatory and clinical policies and procedures. + Participates in quality improvement… more
- Biomat USA, Inc. (Van Nuys, CA)
- …and compliance with all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety ... activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts as a… more
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