- AbbVie (Irvine, CA)
- …and AbbVie study staff. + Responsible for understanding and addressing applicable regulatory requirements related to the clinical studies, clinician reported ... interpretation, presentation and reporting of scientific protocols, Investigator Brochures, Clinical Study Reports, Clinician Reported Outcome Dossiers, regulatory… more
- Amgen (Thousand Oaks, CA)
- …and mentoring of clinical development colleagues in co-authoring and reviewing clinical sections of regulatory documents + Lead the evidence generation ... is desirable + Solid understanding of relevant areas such as biostatistics, regulatory , clinical pharmacology, pre- clinical toxicology approaches + Knowledge… more
- Bristol Myers Squibb (Brisbane, CA)
- …board meetings as Early Clinical Development Physician; serves as Primary Clinical Representative in Regulatory interactions for early development projects + ... Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and… more
- CommonSpirit Health at Home (Sunnyvale, CA)
- …Are you a **dynamic healthcare leader** passionate about driving clinical excellence, ensuring regulatory compliance, and leading high-performing ... Support Clinical Teams** - Oversee Directors of Clinical Services, ensuring high-quality care and regulatory ...of Clinical Services, ensuring high-quality care and regulatory compliance. ✅ **Ensure Regulatory Excellence** -… more
- Ascendis Pharma (Palo Alto, CA)
- … regulatory strategy + Contribute 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 … more
- AbbVie (South San Francisco, CA)
- …lead PK scientist in his/her area of expertise and critically evaluate relevant Clinical Pharmacology, PK/PD and regulatory advances and integrate this knowledge ... development by supporting Phase 1-4 studies including study design, and clinical pharmacology strategy. + Author regulatory documents including protocols, study… more
- Terumo Neuro (Aliso Viejo, CA)
- …study timeline and milestones and to provide regular progress updates. + Support clinical science and regulatory affairs functions by utilizing medical expertise ... to provide input to study design, clinical evaluation reports, clinical study reports, literature review, risk management, regulatory submissions, questions… more
- Bristol Myers Squibb (San Diego, CA)
- …protocols, investigator brochures, clinical study reports, and review of other clinical trial and regulatory documents + Conduct investigator meetings and ... trial investigators and thought leaders + Serve as clinical lead for regulatory interactions, including preparation of briefing documents and attendance and… more
- Ascendis Pharma (Palo Alto, CA)
- …of clinical data + Contribute to drafting and reviewing 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… more
- Dignity Health (Rancho Cordova, CA)
- …of supervisors, leads, and employees across the organization. Position ensures clinical services are effective, meets all regulatory requirements, and ... clinical audits or as instructed by leadership. - Ensure clinical compliance with regulatory agencies and health plans. - Provide clinical leadership to… more