- Saratoga Hospital (Saratoga Springs, NY)
- Clinical Regulatory Readiness Manager Location: Saratoga Hospital, 211 Church Street, Saratoga Springs, NY 12866 Employment Type: Full Time Shift/Schedule: Day ... believe that exceptional care starts with exceptional people. Summary of Position: Clinical Regulatory Readiness position supports the organization, the leaders… more
- Rochester Regional Health (Rochester, NY)
- Job Title: RN - Clinical Regulatory ComplianceDepartment: Clinical Regulatory Compliance Location: Newark Wayne Hospital (also floating to Clifton) Hours ... readiness and survey preparedness. + Supports cross-functional collaboration to enhance clinical excellence, regulatory compliance, and quality outcomes through… more
- Mount Sinai Health System (New York, NY)
- …supporting clinical research compliance by managing and maintaining electronic regulatory binders. This position ensures that all regulatory documentation is ... regulatory affairs teams to uphold institutional and federal standards. Maintaining regulatory compliance in clinical trials is essential for safeguarding… more
- Merck (Albany, NY)
- …+ Conduct initial content review and approval for IND/CSA submissions to enable clinical trial initiation. + Participate in regulatory due diligence activities ... chemistry, or related discipline with 10+ years of relevant drug development, clinical , or regulatory experience. + MD or Ph.D./Pharm D with 7+ years of… more
- Pfizer (Pearl River, NY)
- …(Minimum Requirements)** + BS is required. MS, PharmD, or PhD preferred + Prior clinical regulatory affairs experience in vaccines is required, at least 8 years. ... local and global regulations is crucial, and the constantly evolving regulatory landscape demands forward-thinking and meticulous attention to detail. Your… more
- Pfizer (New York, NY)
- …and business experience providing an understanding of the processes associated with clinical , regulatory and marketing operations. + Capability to provide ... this position will interact directly with Clinical (Clinicians), Clinical Pharmacology, Statistical Programming, Data Management, Regulatory Strategy and… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …of the following tracks: + Clinical Operations & Program Management + Clinical Sciences + Regulatory Strategy + ** Regulatory Labeling & ... **In this program, you may experience:** + Drafting documents integral to clinical sites and regulatory submissions + Analyzing data from clinical studies in… more
- Sumitomo Pharma (Albany, NY)
- …and tactical advancement of the clinical programs, and liaises with Clinical (including Clinical Operations), Biometrics, Regulatory , Early Clinical ... data analysis. + Provide medical expertise to cross-functional teams, including regulatory , commercial, and clinical operations. + Provide day-to-day practical… 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
- Pfizer (Pearl River, NY)
- …level informed consent documents, and contribute to authoring of site training materials, clinical study reports, regulatory responses, and other clinical ... **POSITION SUMMARY** You will provide clinical and scientific program support for a global...and regulatory documents. + Partner with other clinical colleagues, clinical operations and other functional… more