- Weill Cornell Medical College (New York, NY)
- …for this role when Hired for NYC Offices **Position Summary** Oversees the clinical trial regulatory maintenance from study submission through closeout. **Job ... Title: Regulatory Specialist Location: Upper East Side Org Unit:...projects. Prepares and submits all necessary documents to the Clinical Science Evaluation Committee (CSEC), the Institutional Review Board… more
- Pfizer (New York, NY)
- … regulatory tasks. You will play the critical role of providing regulatory strategic direction to teams overseeing clinical development of products and ... and accomplishments. + Liaise with and provide input/direction to Clinical Trial Regulatory Operations, Clinical Diagnostics, and other key stakeholder… more
- Pfizer (New York, NY)
- …informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical ... record of successful regulatory submission, inspection, and regulatory approval + Excellent knowledge of clinical ...and regulatory approval + Excellent knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA,… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- … clinical stages to post commercialization; with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is ... + Formulating a rationale to develop the drug in accordance with a clinical and regulatory strategy. + Working with experts and consultants in the field to… more
- ICON Clinical Research (Farmingdale, NY)
- …of the laboratory operations. This role ensures compliance with all regulatory and accreditation requirements, guides clinical decision-making, and ensures ... medical advancements, technologies, and testing methodologies relevant to high-complexity clinical laboratories. ** Regulatory Compliance & Accreditation:** +… more
- WMCHealth (Poughkeepsie, NY)
- …modifies treatment plans as needed, and performs re-evaluations in compliance with clinical and regulatory standards. + Coordinates care with interdisciplinary ... Speech Language Pathologist - Clinical Fellow Company: MidHudson Regional Hospital City/State: Poughkeepsie,...summaries accurately and in a timely manner to meet regulatory and organizational requirements. + Identifies discharge criteria and… more
- Immigration and Customs Enforcement (Batavia, NY)
- …evaluating clinical case reviews for adequacy of care, compliance with clinical and regulatory guidelines, overpayment, and audit recovery; and developing ... Summary The Clinical Nurse Manager oversees nursing services at ICE...wellbeing of patients. Nurses may function as consultants providing clinical advisory tasks related to such functions as developing… more
- Whitney Young Health Center (Albany, NY)
- …40 hours per year. + Maintains an acceptable level of compliance with clinical and regulatory standards including medical record documentation in accordance with ... Primary Care Physician/Community Prevention and Treatment Services Clinical Lead (Req 100978) Albany, NY (http://maps.google.com/maps?q=920+Lark+Drive+Albany+NY+USA+12207) Apply… more
- Parexel (Albany, NY)
- …assigned programs from early development through approval * Coordinate cross-functional regulatory activities (CMC, nonclinical, clinical ) to meet key milestones ... biologics * Deep knowledge of FDA, ICH, and global regulatory frameworks * Experience with international clinical ...global regulatory frameworks * Experience with international clinical trials and regulatory documentation * Strong… 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