- Stanford University (Stanford, CA)
- …case report forms for completion and accuracy with source documents. Prepare regulatory submissions , and ensure institutional Review Board renewals are ... + Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out. + Determine eligibility… more
- Stanford University (Stanford, CA)
- …case report forms for completion and accuracy with source documents. Prepare regulatory submissions , and ensure institutional Review Board renewals are ... + Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out. + Determine eligibility… more
- Stanford University (Stanford, CA)
- …case report forms for completion and accuracy with source documents. Prepare regulatory submissions , and ensure institutional Review Board renewals are ... *Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out. *Determine eligibility… more
- Stanford University (Stanford, CA)
- …case report forms for completion and accuracy with source documents. Prepare regulatory submissions , and ensure institutional Review Board renewals are ... * Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out. * Determine eligibility… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream ... processing. + Collaborate closely with Upstream MSAT, Validation MSAT, QA, Regulatory , Process Development, Analytical Development, and CDMO technical teams. + Stay… more
- Stryker (Fremont, CA)
- …artwork, design verification, shelf life testing, label design, and support regulatory submissions . To learn more about Stryker's Neurovascular portfolio ... of Customer insights. + Collaborate cross-functionally with quality, manufacturing, regulatory , clinical, marketing, R&D device designers, supply chain, vendors, and… more
- Abbott (Pleasanton, CA)
- …ISO, IEC 62304).Support documentation, verification, and validation processes required for regulatory submissions and audits. + Continuous Improvement & ... will collaborate cross-functionally with development, product, operations, quality, and regulatory teams to ensure the delivery of high-quality, compliant software… more
- IQVIA (Carlsbad, CA)
- …issues as appropriate. * Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form ... and close-out visits) in accordance with contracted scope of work and regulatory requirements, ie, Good Clinical Practice (GCP) and International Conference on… more
- Ascendis Pharma (Palo Alto, CA)
- …to drafting and reviewing of clinical documents, manuscripts, presentations, and regulatory submissions + Maintain up-to-date knowledge of relevant science, ... medical information, good clinical practices, and regulatory guidance + Collaborate with-and serve as a clinical research resource for-cross-functional colleagues… more
- IQVIA (Carlsbad, CA)
- …escalating quality concerns when necessary. + Track study progress including regulatory submissions , subject enrollment, case report form (CRF) completion, ... for monitoring clinical trial sites to ensure compliance with study protocols, regulatory guidelines, and sponsor requirements. Your work will directly support the… more