- Johns Hopkins University (Baltimore, MD)
- …JHU investigator held INDs and IDEs in accordance with the JHU governing guideline. The IND / IDE Program Director will develop and maintain all ... Classified Title: Sr. Policy Associate Job Posting Title (Working Title): IND / IDE Program Director Role/Level/Range: ATP/04/PF Starting Salary… more
- Lilly (Indianapolis, IN)
- …the_ _US and Canada_ _strategy for submission and amendments for IND , IDE ,_ _CTA_ + Determineand communicatesubmission andapprovalrequirements and regulator ... around the world. Purpose: The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role...teams, are aligned to the Global Brand Development (GBD)/global program team and business priorities in terms of the… 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
- Children's Hospital Boston (Boston, MA)
- …Posting Description:The Regulatory Affairs and Education Manager will report to the Director , Regulatory and Education Program in Clinical Research Operations ... in the preparation, submission and maintenance of Investigational New Drug ( IND ) and Investigational Device Exceptions ( IDE ) applications. + Serve… more
- University of Pennsylvania (Philadelphia, PA)
- …problems, etc., and address regulatory reviewer inquiries. Provide assistance with IND / IDE /CTA exemption determinations. PM-A: Manage study budgets and assure ... problems, etc., and address regulatory reviewer inquiries. Provide assistance with IND / IDE /CTA exemption determinations. PM-B: Develop, negotiate and manage… 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)
- …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 Pennsylvania (Philadelphia, PA)
- …submissions and data entry). + May be responsible for writing investigator-initiated IND / IDE clinical trials in collaboration with faculty supervisor. Speak at ... Research Project Manager A Job Description Summary The Pennsylvania Hospital Research Program of the University of Pennsylvania seeks a full-time Sr. Clinical… more