- Stanford University (Stanford, CA)
- …and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. + Proven ... + Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out. + Determine eligibility… more
- Ascendis Pharma (Palo Alto, CA)
- …(Argus preferred) + Experience with MedDRA coding and global safety reporting regulatory requirements. + Expert knowledge of FDA safety regulations, ICH ... create Corrective Action and Preventative action (CAPA) as applicable. + Oversee regulatory and departmental compliance by ensuring timely processing of ICSRs in the… more
- Sumitomo Pharma (Sacramento, CA)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… 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
- Abbott (Alameda, CA)
- …state of continuous inspection readiness and ensuring compliance with applicable regulatory requirements, including ISO 13485 and MDSAP. The Compliance Specialist ... inspection readiness program to ensure the site is always prepared for regulatory and internal audits. + Coordinate and support internal audits, including planning,… more
- Charles River Laboratories (Hollister, CA)
- …+ Consult with site management and employees on Federal, State, and Local regulatory compliance related issues. Work with site facility management to ensure proper ... environmental reports and permits to local, state and federal regulatory agencies. + Work with site Leadership and Site/Global...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- …are designed and manufactured in compliance with applicable industry and regulatory standards and meet customer expectations for safety and effectiveness. Reporting ... Quality Management System (QMS) aligned with corporate policies and regulatory requirements, supporting both new product development and sustaining engineering… more
- 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 supports ... plans, and presentations. + Provides oversight of study sites/region and reviews routine regulatory documents to ensure that CROs are in compliance with protocols, … more
- Stanford Health Care (Palo Alto, CA)
- …and standards. The Director will collaborate with quality management and external regulatory and accrediting entities to ensure all mandated services and standards ... and goals of SHC and which meet the external regulatory and statutory requirements. + Effectively assists in providing...requirements including, but not limited to, JCAHO, CAP, OSHA, FDA and compliance with EMTALA regulations. + Guides the… more
- Pfizer (South San Francisco, CA)
- …clinical study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. + Foster a transparent environment that builds strong ... external partners, such as project leaders, research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, translational oncology, precision… more