- Stanford University (Stanford, CA)
- …study specific milestones, and invoice sponsors according to study contract. + Ensure regulatory compliance . Regularly inspect study document to ensure ongoing ... regulatory compliance . + Work with principal investigator to ensure Investigational...regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical… more
- Stanford University (Stanford, CA)
- …study specific milestones, and invoice sponsors according to study contract. + Ensure regulatory compliance . Regularly inspect study document to ensure ongoing ... regulatory compliance . + Work with principal investigator to ensure Investigational...regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical… more
- Stanford University (Stanford, CA)
- …study specific milestones, and invoice sponsors according to study contract. + Ensure regulatory compliance . Regularly inspect study document to ensure ongoing ... regulatory compliance . + Work with principal investigator to ensure Investigational...regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical… more
- Stanford University (Stanford, CA)
- …study specific milestones, and invoice sponsors according to study contract. + Ensure regulatory compliance . Regularly inspect study document to ensure ongoing ... regulatory compliance . + Work with principal investigator to ensure Investigational...regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical… more
- Abbott (Alameda, CA)
- …the support of the Quality System are developed, validated and maintained in compliance with regulatory and corporate requirements. This is an individual ... File (DHF) and Device Master Record (DMR) are in compliance with regulatory standards and quality management...+ Develops and maintains departmental operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines,… more
- Element Materials Technology (Santa Fe Springs, CA)
- …observations + Assist in audit preparedness and for participating in quality audits with FDA , other Regulatory Agencies, and customers, as needed + Ensures work ... testing to meet client requirements and in accordance to regulatory and company guidelines. Set up and confirm suitable...is in compliance with all state and federal regulations, including but… more
- IQVIA (San Francisco, CA)
- …to make a significant impact in the field. A strong background in current FDA regulatory expectations and the global landscape in Rare Disease or Pediatrics. ... Provide strategic and therapeutic area guidance for clinical development plans in compliance with applicable regulatory , medical, and ethics guidelines. + Ensure… more
- UCLA Health (Los Angeles, CA)
- …In this role you will manage unit operations to ensure compliance with departmental and organizational policies, procedures, and defined internal controls. ... study protocol and applicable regulations, such as institutional policy and procedures, FDA Code of Federal Regulations (CFR), and ICH Good Clinical Practice (GCP).… more
- Stanford Health Care (Palo Alto, CA)
- …collaboration between providers and coordination of community resources. + Ensures compliance with legal, regulatory and clinical policies and procedures. ... B-cell lymphoma, where CAR T-cell therapy has become an FDA -approved standard of care. We are now expanding our...Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA -… more
- BeOne Medicines (San Mateo, CA)
- …communication and influence with internal stakeholders (eg, clinical development, medical, regulatory , labeling) and external stakeholders (eg FDA , MHRA, EMA, ... evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory -required periodic reporting._ _Physicians in this… more