- Gilead Sciences, Inc. (Foster City, CA)
- …teams to design and implement clinical studies + Document writing and review - Including but not limited to, protocols, investigator brochures, clinical study ... in a team with key cross functional partners including regulatory affairs, patient safety, clinical operations, biostatistics, clinical pharmacology, research/… more
- AbbVie (San Francisco, CA)
- …scientific content of protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses. + Has overall responsibility for oversight ... the Medical Affairs-led clinical studies, monitoring overall study integrity and review , interpretation and communication of accumulating data pertaining to safety… more
- Banc of California (Santa Ana, CA)
- …and Operations and KYCs from the front line are in compliance with regulatory requirements. The candidate will assist with various initiatives, including but not ... identify any potential control gaps or issues by staying abreast of the regulatory environment and trends (eg, performing an enforcement action gap analysis). +… more
- Ascendis Pharma (Palo Alto, CA)
- …all applicable laws and regulations and as appropriate, local and foreign regulatory reporting requirements and for signal detection, evaluation and risk management. ... reports received from any source are reviewed according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures. . Liaises with Medical… more
- The Brattle Group (San Francisco, CA)
- …consulting firm. We provide expert analysis and testimony in legal disputes, regulatory proceedings, and business strategy. Our teams apply economic, financial, and ... decisions in areas such as corporate finance, energy, competition, and regulatory economics. **WHAT IS ECONOMIC CONSULTING?** Economic consulting involves using… more
- BMO Financial Group (San Francisco, CA)
- …uncover financial needs and provide meaningful solutions in compliance with regulatory and compliance policies. Works collaboratively within the market, BMO ... to uncover financial needs and provide meaningful solutions in compliance with regulatory and compliance policies. + Works collaboratively within the market, BMO… more
- Cardinal Health (Sacramento, CA)
- …to commercial, corporate securities, intellectual property, labor and employment, and regulatory law, among other areas. This function also litigates all company ... (GPOs, IDNs, hospitals, physician offices, etc.), strategic sourcing, marketing, regulatory /compliance and contract manufacturing. **_Responsibilities_** + Demonstrate strong business… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …aspects of downstream process technology transfers to CDMOs, including documentation review , gap analysis, and risk assessment. + Provide expert technical oversight ... of downstream manufacturing operations at CDMOs, including review of batch records, deviation investigations, and change controls. + Lead or significantly contribute… more
- Takeda Pharmaceuticals (Los Angeles, CA)
- …for Teardown, Fractionation, and Purification following cGMP, GDDP, FDA and Regulatory Standards, ISO requirements, and internal standard operating procedures. The ... Quality on the Shop Floor oversight to manufacturing batch record and documentation review for accuracy and compliance to procedure, Quality on the Shop Floor… more
- LA Care Health Plan (Los Angeles, CA)
- …Direct, Medicare, PASC-SEIU and LA Care Covered) in a manner consistent with regulatory requirements from the Department of Managed Health Care, Department of Health ... opportunities for improvement. Ensures timely appeal and grievance reporting to regulatory agencies, internal Regulatory Affairs and Compliance Department,… more