- Fresenius Medical Center (Waltham, MA)
- …can be fully remote. **PURPOSE AND SCOPE:** Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product ... compliance. Develops, coordinates, reviews and prepares documentation packages for pharmaceutical regulatory submissions (Primarily US). May act as FDA liaison for… more
- Fresenius Medical Center (Waltham, MA)
- …AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Operations for the preparation of regulatory submissions required to ... RESPONSIBILITIES:** + A seasoned, experienced professional with a full understanding of Regulatory Operations; resolves a wide range of issues in creative ways. +… more
- Veterans Affairs, Veterans Health Administration (Boston, MA)
- …and providing clinical specifications and definitions. Reporting to and interaction with regulatory bodies, including the VA Central IRB, VA Boston IRB, FDA and ... influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Participation in the Coronavirus Disease 2019… more
- Veterans Affairs, Veterans Health Administration (Boston, MA)
- …stress and PTSD. 4. Prepares and ensures compliance with all research regulatory requirements. 5. Prepares and submits initial, ongoing, and final reporting ... research focused committees including editorial boards, grant review panels, and regulatory boards. 1. Academic/Teaching/Training (5% effort) - Will hold a faculty… more