- Memorial Sloan-Kettering Cancer Center (New York, NY)
- …products. The team oversees the management of MSK's Investigational New Drug and Device ( IND / IDE ) Program and provide expert guidance to MSK investigators on ... be onsite as needed + Reporting to the Senior Director , Product Development and Regulatory Compliance Pay Range: $98,500...regulatory and product development strategy for MSK's IND / IDE studies including the preparation of … more
- University of Utah (Salt Lake City, UT)
- …and report forms. 2. Prepares and facilitates advanced regulatory submissions, including IND and/or IDE applications and reports. 3. Analyzes and mitigates ... rules and regulations, including complex protocol, multi-site trial and IND / IDE issues. 8. Offers mentorship...discriminate on the basis of sex in the education program or activity that it operates, as required by… more
- University of Pennsylvania (Philadelphia, PA)
- …managing different quality aspects of cell manufacturing, participate in drafting IND / IDE Chemistry, Manufacturing and Controls (CMC) sections, including ... clinical trials under Investigational New Drug or Device Exemptions ( IND /IDEs) approved by the FDA, some of which are...available. The candidate is encouraged to tailor the one-year program to suit individual background and needs, while still… more
- University of Miami (Miami, FL)
- …Compile regulatory-related metrics for use by senior management. Preparation and submittal of IND and/or IDE applications and annual reports to the FDA for ... Analyst 3 - UHealth assists the Regulatory Manager and/or Director of Regulatory with the day-to-day operations related to...the development and improvement of the + department's mentorship program . + Assists with the training of all regulatory… more
- Children's Hospital Los Angeles (Los Angeles, CA)
- …data management, and coordination of investigational product. IDE / IND submission experience preferred. **Education/Licensure/Certification:** Bachelor's ... center, with guidance from the appointed consortium leaders (eg, Consortium Medical Director , Associate Medical Director , Administrative Director , etc.). The… more
- University of Miami (Miami, FL)
- …submission to IRBs, sponsors and master agreements, and coordinates with the Research Program Director on remediation. + Coordinates the efforts of relevant team ... quality and timeline issues appropriately. + Manages investigator relationships. + Maintains IND and IDE documentation, including annual reports for delegated… more
- University of Miami (Miami, FL)
- …submission to IRBs, sponsors and master agreements, and coordinates with the Research Program Director on remediation. + Coordinates the efforts of relevant team ... quality and timeline issues appropriately. + Manages investigator relationships. + Maintains IND and IDE documentation, including annual reports for delegated… more