- 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
- University of Colorado (Aurora, CO)
- …continually improves processes related to initial intake and assessments as required under the IND / IDE program for projects requiring submissions to the FDA. ... meetings, to support and improve the operations of the IND / IDE program . + In collaboration...data quality controls, in close collaboration with the Medical Director and Principal Investigator + Monitors e-mail for safety… more
- Lilly (Indianapolis, IN)
- …the_ _US and Canada_ _strategy for submission and amendments for IND , IDE ,_ _CTA_ + Determineand communicatesubmission andapprovalrequirements and regulator ... better for people around the world. Purpose: The purpose of the Senior Director /Executive Director , Global Regulatory Affairs, Global Regulatory Lead (GRL) role… 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)
- …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 Pennsylvania (Philadelphia, PA)
- …candidate will possess a thorough knowledge of Federal Regulations, GCP and IND / IDE in research. Must understand regulatory affairs and their applications ... resources, and much more. Posted Job Title Clinical Research Program Manager Job Profile Title Clinical Research Program...B Job Description Summary Working in partnership with the Director of Clinical Research of the Center for Cytokine… 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