- Sutter Health (Antioch, CA)
- …billing, pricing, record keeping, and provision of services required to meet regulatory requirements. + Maintains records of drug distribution, works with ... of Homeland Security (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration ( FDA ) and United States Pharmacopeia (USP). + Possess written… more
- Sutter Health (Antioch, CA)
- …billing, pricing, record keeping, and provision of services required to meet regulatory requirements. + Maintains records of drug distribution, works with ... of Homeland Security (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration ( FDA ) and United States Pharmacopeia (USP). + Possess written… more
- Pfizer (South San Francisco, CA)
- …contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports ... qualified colleague/s, analyze the emerging safety profile of the drug , keeping the clinical and safety colleagues informed of...the sponsor and with a track record of successful regulatory submission, inspection, and regulatory approval +… more
- Charles River Laboratories (San Diego, CA)
- …We have proudly worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits ... in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will...advise management on safety and environmental issues. Review new regulatory standards and make compliance recommendations. + Inspect the… more
- Stanford Health Care (Palo Alto, CA)
- …to coordinate drug therapy. + Participates in audits from the sponsors, FDA , DEA, NIH and other regulatory agencies as needed. **Education Qualifications** + ... serve as a member and consultant on treatment or diagnostic teams; disseminates drug information to members of the hospital staff and interested community groups;… 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. + ... clients navigate the complexities at each step of the drug development life cycle -and get the right treatments...structured queries, ensuring that extracted data aligns with research, regulatory , and business objectives. This role is critical in… more
- Charles River Laboratories (Northridge, CA)
- …such as Standard Operation Procedure manuals, Current Good Manufacturing Practices, FDA and AABB regulations. **Job Qualifications** * High school diploma or ... customization of human-derived biological products and services for biomedical research, drug discovery, and cell and gene therapy development. Cell Solution's… more
- Ascendis Pharma (Palo Alto, CA)
- …(Argus preferred) + Experience with MedDRA coding and global safety reporting regulatory requirements. + Working knowledge of FDA safety regulations, ICH ... 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
- Gilead Sciences, Inc. (Foster City, CA)
- …program, policies, and procedures to ensure compliance with GxP standards, corporate policies, FDA , EMA, and other regulatory body regulations and guidelines. + ... benefiting hundreds of thousands of people, a pipeline of strong late-stage drug candidates, and unmatched patient access programs to ensure medications are… more
- Genentech (South San Francisco, CA)
- …environments impacting Roche/Genentech, coupled with thorough knowledge of US regulatory / FDA requirements. + Scientific credibility and enterprise thinking ... as a key medical spokesperson internally and externally with various committees, regulatory bodies, and industry forums. This individual will represent USM across… more