- System One (Tarrytown, NY)
- Regulatory Submission Project Management Specialist Location: Remote Term: 12-month renewable (CONTRACT TO HIRE) Target Pay: $30-$36/HR Must have recent PHARMA ... regulatory experience, preferably working on submissions. The Temp ... submissions, such as those for IND safety reports, clinical site documentation updates (1572s), lot releases, promotional pieces… more
- Sumitomo Pharma (Albany, NY)
- …functional groups + Responsible for providing global guidance and monitoring of global regulatory line items in the clinical development projects budget process ... and experienced individual for the position of Vice President, Regulatory Affairs, Biopharma R&D. This position leads the ...Regulatory Affairs, Biopharma R&D. This position leads the Regulatory Affairs for biopharma R&D, report to the Chief… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …Develop and maintain project plans to closely track CDx development and CDx regulatory activities against clinical drug development and study timelines + Review ... drug development pipeline in partnership with Diagnostic Strategy Leads and IVD Regulatory Affairs. This is a leadership role within Regeneron's clinical … more
- Mount Sinai Health System (New York, NY)
- …Good Clinical Practice (GCP) guidelines, institutional policies, and applicable regulatory requirements (eg, FDA, IRB, ICH). + Oversee the preparation and ... **Project Manager II** will oversee the entire portfolio of Investigator-Initiated Clinical Trials (IICTs)/ Clinical Research Sponsor Collaboration (CRSC) within… more
- WMCHealth (Suffern, NY)
- …oversees the day-to-day operations of assigned departments, which may include clinical oversights, quality assurance, regulatory compliance, educational and ... staffing schedules for respiratory therapists. + Assigns projects to clinical and non- clinical staff under scope of responsibility. + Plans and reviews… more
- Excellus BlueCross BlueShield (Rochester, NY)
- …& Data, Communications, Finance, Marketing & Sales, Project Management, Clinical Studies, Customer Experience, Digital Operations, and other non-technical and/or ... gain experience with overseeing implementation and project work related to regulatory mandates and regulatory requirements to ensure enterprise-wide compliance.… more
- Equinox, Inc (Albany, NY)
- …including participation in compliance program. + Compile essential reports (including clinical , supervisory, fiscal, regulatory and evaluative) + Achieve units ... of service and revenue goals + Manage budget, including participating in budget development + Ensure that all records are maintained consistent with regulations (OMH, HIPAA, etc.) + Provide scheduled supervision to all Case Managers on a monthly basis; provide… more
- SUNY Upstate Medical University (Syracuse, NY)
- …for trainees and clinicians. Being trained and then aiding in compliance with clinical and educational regulatory bodies. Being trained and then aiding in ... budgeting processes. Work in diverse environments with people of different backgrounds. Must be a strong communicator and able to develop an effective partnership with providers, staff and all stakeholders, regardless of their cultural, ethnic, and racial… more
- KPH Healthcare Services, Inc. (East Syracuse, NY)
- **Overview** **Scope of Responsibilities:** Responsible for all regulatory , compliance, and accreditation matters within HealthDirect. Oversees the development, and ... policy and procedure. Responsible for the overall management of the clinical team and corresponding policy, procedure, and programs. **Job Summary:** Reporting… more
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