- ThermoFisher Scientific (Richmond, VA)
- … Clinical Development Plan. + Provide support for critical day-to-day clinical study activities, including regulatory inspection readiness, in accordance with ... Development Plan. The CTC will provide support for critical day-to-day clinical study activities, including regulatory inspection readiness, in accordance with… more
- Teleflex (PA)
- … study contracts based on substantial knowledge of financial/fair market value, regulatory and clinical requirements while demonstrating clinical knowledge. ... correspondence and agreements in accordance with procedures. * Monitor changes to regulatory and legal requirements affecting clinical study contracts and… more
- CSL Behring (King Of Prussia, PA)
- …(ICF), Medical Monitoring Plans (MMP), Clinical Study Reports (CSR).** **the clinical sections of relevant regulatory packages (eg IND, NDA, annual reports) ... provides support in defining the development strategy. + Leads preparations of clinical sections of relevant regulatory interaction packages including but not… more
- Bristol Myers Squibb (Princeton, NJ)
- …and advisory board meetings as Clinical Trial Physician + **Authors/drafts clinical content** for CSRs, regulatory reports, briefing books and submission ... at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Clinical Trial Physician sits within Clinical Development, which is a… more
- CSL Behring (King Of Prussia, PA)
- …(ICF), Medical Monitoring Plans (MMP), Clinical Study Reports (CSR). + the clinical sections of relevant regulatory packages (eg IND, NDA, annual reports) ... Charters, and Clinical Study Reports (CSR). + Leads preparations of clinical sections of relevant regulatory interaction packages including but not limited… more
- Stanford University (Stanford, CA)
- …to detail. + Ability to produce timely and accurate reports to monitor regulatory and clinical processes. + Practical knowledge and experience with internal ... Clinical Research Coordinator 2 (Hybrid Opportunity) **School of...and invoice sponsors according to study contract. + Ensure regulatory compliance. Regularly inspect study document to ensure ongoing… more
- Gilead Sciences, Inc. (Foster City, CA)
- …documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications and ... criteria, toxicity management, and drug safety surveillance. + Manages the clinical development component(s) in the preparation/review of regulatory documents,… more
- Edwards Lifesciences (Irvine, CA)
- …language and budgets) based on substantial knowledge of financial/fair market value, regulatory and clinical requirements while demonstrating clinical ... clinical study contracts, including familiarity with terms and conditions, regulatory compliance, and stakeholder collaboration + Previous clinical research/… more
- Pfizer (South San Francisco, CA)
- …and external partners, such as project leaders, research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, translational oncology, ... Experience working with and solid understanding of related disciplines, eg, Clinical Operations, Safety, Biostatistics, Regulatory , Study Management, Pre-… more
- Vitalief (New Brunswick, NJ)
- …needed. + Facilitates clinical trial billing administrative start-up, insuring clinical research billing and regulatory compliance. Collaborate with Finance ... analysis and research of financial data and transactions. + Experience in clinical research administration; knowledge of regulatory , financial and administrative… more