- Regeneron Pharmaceuticals (Tarrytown, NY)
- …of clinical development programs to support decision milestones and regulatory requirements. This role is a clinical subject matter expert ... for successful global registration of the compound. + Leads creation of clinical components of key documents ( regulatory documents, registration dossiers, etc.)… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- … team(s) working closely with Operational Leads to guide and execute clinical development strategies and subsequent regulatory submissions. This role requires ... clinical documents (eg, Investigators' Brochure, protocol, study report, clinical components of regulatory submissions, safety related documents). Develops… more
- Pfizer (New York, NY)
- …or supports other critical documents, eg, protocol amendments, investigator brochure, and regulatory documents. + Collaborate with Clinical Operations to ensure ... regarding strategy and/or data, and may assist with authoring clinical sections of regulatory documents (IB, Annual Reports, IND sections, CSR). + Support… more
- Mount Sinai Health System (New York, NY)
- …complete, and submitted in a timely manner + Ensure the integrity of clinical trials, maintaining regulatory compliance and contributing to the overall success ... **Job Description** The Clinical Research Coordinator assists in the daily activities...through chart reviews. + Assists the Principal Investigator and regulatory staff in the preparation of new protocol submissions,… more
- FlexStaff (New York, NY)
- …quality care delivery. Stay informed about current health-related issues, evidence-based clinical practices, and regulatory changes. Managerial Oversight and ... **Req Number** 156193 FlexStaff is looking for RN Clinical Managers The Clinical Manager - Integrated Care plays an essential role in ensuring that participants… more
- New York State Civil Service (Montrose, NY)
- …with FNPs, to provide quality health care services, while also ensuring compliance with clinical , statutory, and regulatory standards. You will be caring for an ... NY HELP No Agency Health, Department of Title Clinical Physician 1 - NYS Veterans' Home at...and attend interdisciplinary care team reviews, along with other Clinical responsibilitiesThis title is part of the New York… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Regeneron Genetics Center, Regeneron Cellular Medicine, the Oncology and Hematology Clinical Development Units on regulatory strategies for the development ... The role leads a group within Regeneron's Regulatory Affairs organization that provides guidance to Research,… more
- Mount Sinai Health System (New York, NY)
- …preferred, or equivalent combination of education and applicable experience (preferred: research or regulatory ) + 3 years of experience in clinical research or a ... the protocol to be implemented by investigator(s), program manager(s), clinical research coordinator(s), regulatory coordinator(s), and research nurse(s).… more
- Sumitomo Pharma (Albany, NY)
- …of clinical study-related documents such as protocols, protocol amendments, clinical study reports (CSRs), regulatory submissions and other publications as ... and problem solving + Working knowledge of current global regulatory requirements and guidelines for clinical trials. The base salary range for this role is… more
- Bausch + Lomb (Albany, NY)
- …global team members, other B&L departments (eg, R&D/Project Management, Clinical /Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, ... manage and monitor study related expenses to meet forecast. Regulatory Reports: + Provide Clinical Operations support in the timely coordination and execution of… more