- Gilead Sciences, Inc. (Foster City, CA)
- …trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high- quality clinical data that ... plans, and presentations. + Provides oversight of study sites/region and reviews routine regulatory documents to ensure that CROs are in compliance with protocols, … more
- Amgen (Thousand Oaks, CA)
- …pre-clinical toxicology approaches + Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory ... range of audiences, including executive leadership, development partners, and global regulatory agencies. This role will include global development leadership of one… more
- AbbVie (South San Francisco, CA)
- …+ Pharmaceutical experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA. NDA/BLA or other ... related to output design and programming conventions. Responsible for monitoring regulatory guidance and industry best practices. *Case report forms and database… more
- Stanford University (Stanford, CA)
- …to precision medicine in mental health and neuroimaging trials + Experience with FDA regulatory procedures and reporting + Demonstrated capacity to solve ... believes "Neuroscience is Personal." Our ethos is collaborative and one that believes quality science goes hand in hand with mutual respect (More information on our… more
- Abbott (Sylmar, CA)
- …catch potential issues early and ensure smooth releases. + Work with QA, regulatory , and external partners to bring high- quality , compliant software to market. ... device software. You'll work closely with developers, QA, and regulatory teams to ensure our systems are fast, reliable,...ensure our systems are fast, reliable, and compliant with FDA and ISO standards. **What You'll Work On** As… more
- ThermoFisher Scientific (San Diego, CA)
- …Familiar with degradation pathways and forced degradation studies. + Strong knowledge of GMPs, quality systems, and FDA and ICH guidelines, such as ICHQ1. + ... digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities… more
- Sutter Health (Oakland, CA)
- …Ensure compliance with accreditation standards (eg, URAC, ACHC); collaborate with the quality assurance team on documentation. + **Cold Chain Packaging & Shipping:** ... role involves a fast-paced environment with an emphasis on compliance and regulatory standards in patient care and medication management. **PHARMACY SERVICES** +… more
- Sutter Health (Berkeley, CA)
- …of pharmaceutical services including drug preparation, distribution, inventory control, quality control, and proper documentation according to policy and procedure. ... billing, pricing, record keeping and provision of services required to meet regulatory requirements. *Maintains records of drug distribution, works with vendors to… more
- Medtronic (Northridge, CA)
- …integrates with biological evaluation report (BER). + Liaise with internal (manufacturing, regulatory , quality , product development, supplier quality , post ... concise, and well-structured biocompatibility evaluation plans and reports to support regulatory submissions. The Senior Product Engineer applies scientific rigor in… more
- Lactalis American Group Inc. (Tulare, CA)
- …Supervisor Tulare, CA (http://maps.google.com/maps?q=10800+Ave+184+Tulare+CA+USA+93274) * Quality Job Type Full-time Description TITLE: Sanitation Supervisor ... of the plant, ensuring that we meet all the regulatory criteria used to measure cleanliness while still maintaining...Key responsibilities for this position include: + Assists the Quality Department manager to enhance the technical and financial… more