- Gilead Sciences, Inc. (Foster City, CA)
- …and CAPA management team within Gilead R&D Quality on internal audits, regulatory agency inspections, risk assessment, deviations and CAPA activities + Liaison and ... including authoring and reviewing SOPs, facilitating internal audits, supporting regulatory inspections, developing and managing CAPAs and deviations, and training… more
- Sumitomo Pharma (Sacramento, CA)
- …Evaluation and Mitigation Strategy (REMS) + Contributes to PVRM and cross-functional drug development teams and manages Safety Charters + Handles Health Hazard ... Evaluations and Ad-Hoc Regulatory safety inquiries. + Represents PVRM on post-marketing product...Experience** + **Medical Degree (MD) with 3-5 years of drug safety experience in a pharmaceutical company** + Experience… more
- Norstella (Sacramento, CA)
- …ensuring the integrity and reliability of insights provided to clients while adhering to regulatory requirements such as HIPAA, GDPR, and FDA RWE guidance. + ... requests into structured queries, ensuring that extracted data aligns with research, regulatory , and business objectives. This role is critical in ensuring our… more
- Ascendis Pharma (Palo Alto, CA)
- …of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations. + Ability to ... 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… more
- Cedars-Sinai (Beverly Hills, CA)
- …best practice care delivery, collaborating with other healthcare team members. + ** Regulatory Compliance:** Utilize knowledge of regulating agencies ( FDA , USP, ... Expertise:** Oversee and manage the pharmaceutical supply chain, including drug shortage management, liaison activities with key partners (Vizient, McKesson,… more
- Bayer (Berkeley, CA)
- …New Product Introduction is beneficial; + Strong understanding of data integrity, regulatory requirements ( FDA , EMA, etc.), and cGMP requirements for ... **Production Specialist II-CSI** Responsible for clinical manufacturing of novel cell therapy drug substance and drug product within the Cell Therapy Module,… more
- Sutter Health (San Francisco, CA)
- …of Homeland Security (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration ( FDA ) and United States Pharmacopeia (USP). + Possess written ... packaging, and labeling pharmaceuticals. + Controls medications by monitoring drug therapies; advising interventions. + Ensures that routine and priority… more
- Sutter Health (Castro Valley, CA)
- …of Homeland Security (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration ( FDA ) and United States Pharmacopeia (USP). Possess written ... packaging, and labeling pharmaceuticals. * Controls medications by monitoring drug therapies; advising interventions. * Ensures that routine and priority… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and effectively articulates and interprets these. + Thorough knowledge of Food & Drug Administration ( FDA ), European Medicines Agency (EMA), and other applicable ... trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports… more
- AbbVie (Irvine, CA)
- …throughout our quality system. May be required to prepare and present data during regulatory audits ( FDA , EMA, Anvisa, etc) and internal audits. *Interact with ... conformance with AbbVie Quality System requirements and all applicable regulatory requirements. *Supplier oversight, assuring responsible Third Parties are complaint… more