- 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
- Parexel (Albany, NY)
- …this is the ideal role.** We're currently seeking a highly experienced Clinical Regulatory Leader, Health Authority Medical Review Team Lead, Master/Senior ... - 15+ years experience with expert level industry or regulatory knowledge experience in Clinical Development/ Clinical Trial Design, Clinical Strategy,… 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
- Sumitomo Pharma (Albany, NY)
- …HTA submissions. The individual will be responsible for leading development of all non- clinical and clinical regulatory strategies including management of ... to advance business goals + Provide leadership and direction to clinical regulatory . Provide coaching and development and drive a culture of excellence… more
- Mount Sinai Health System (New York, NY)
- …trials for the division. Duties include, but are not limited to, management of clinical studies through the regulatory portion of the trial submission process, ... ensuring regulatory integrity of assigned clinical trials from approval to closure, develop new ...A minimum of 5 years of research experience in Regulatory Affairs, Clinical Affairs or Quality Assurance… more
- 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