- 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
- Banner Health (Gilbert, AZ)
- …protocol-specific assessments and monitor for adverse events, infusion reactions, and clinical changes. Reports findings per protocol and regulatory ... preferred. Chemotherapy/Biotherapy Certification. Previous relevant experience working in a clinical research setting. Regulatory knowledge regarding the conduct… 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
- AbbVie (North Chicago, IL)
- …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
- Community Health Systems (Franklin, TN)
- …The EVP collaborates with internal and external stakeholders to enhance clinical outcomes, operational performance, regulatory compliance, and financial results ... strategic goals. **Essential Functions** + Provides executive oversight of key clinical services, ensuring alignment with organizational goals, regulatory … more
- Penn Medicine (Philadelphia, PA)
- …(research initiatives, resident program), special clinical programs, multiple clinical specialties, complex regulatory requirements, management of external ... Working for this leading academic medical center means collaboration with top clinical , technical and business professionals across all disciplines. Today at Penn… more
- Houston Methodist (Houston, TX)
- …following established procedures. **QUALITY/SAFETY ESSENTIAL FUNCTIONS** + Maintains records for clinical study and regulatory documents. + Under the direction ... and reports Adverse Events (A/E) or Serious Adverse Events (SAE) to necessary regulatory authorities. + Assists management with research records and regulatory … more
- Regeneron Pharmaceuticals (Warren, NJ)
- … clinical research methodology & medical writing skills. Knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines. Proven ... The Senior Manager, Hematology, Clinical Scientist leads in the development, evaluation, planning... Study Reports and may support the development of regulatory documents; may perform quality review + Maintains compliance… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- … program. Clinical deliverables may include individual protocols; clinical components of regulatory documents/registration dossier and brand related ... The Senior Medical Director, Clinical Sciences is responsible for facilitating assigned studies,...study design and research methodology as well as understand Regulatory and compliance landscape in the pharmaceutical industry. This… more
- Stryker (Trenton, NJ)
- …activities in alignment with quality standards, ICH guidelines, GCP, and regulatory requirements. This includes establishing and maintaining clinical trial ... databases are in accordance with internal and external established clinical trial and regulatory standards, and local procedures. + Train internal and external… more