Are you an Investigational New Drug Specialist with experience in Investigational New Drug Applications (INDs) and Investigational Device Exemptions (IDEs) regulatory support, comprehensive knowledge of FDA regulations, and the approval process of INDs and IDEs?
If so, the National Institutes of Health (NIH), Clinical Center (CC), Office of Research Support and Compliance (ORSC), is looking for Investigational New Drug Specialists who have skill in applying standards and methods of health sciences in order to serve as a technical expert and provide regulatory guidance for the development of regulatory strategies for the preparation, submission, approval, and record maintenance of IND and IDE documents/submissions to the FDA as described in 21 CFR 312 and 21 CFR 812.
As an Investigational New Drug Specialist, you will be responsible for managing a portfolio of INDs and IDEs where the ORSC serves as the Sponsor’s Authorized Representative. You will also assist investigators, boards, and Committees within the NIH IRP with FDA inspections and serve as a liaison to NIH leadership to support for-cause and routine inspections by the FDA, so please make sure to highlight and thoroughly describe your experience in your resume.
The NIH Clinical Center (NIH) is the largest federally funded hospital in the world totally dedicated to biomedical and translational clinical research. The hospital has 200 beds to support inpatient studies and outpatient clinics to support 1,600 clinical research studies among the intramural research programs of twenty-seven Institutes and Centers across the NIH. These positions are located in the Office of Research Support and Compliance (ORSC), of the Clinical Center (CC), National Institutes of Health (NIH). This Office is responsible for ensuring the quality and integrity of the research conducted at the NIH including overseeing compliance with the regulations/guidelines investigational drugs and devices.
This is a Title 5 federal appointment in the competitive service. Salary will be commensurate with experience and accomplishments. A full package of benefits (including retirement, health, life and long-term care insurance, Thrift Savings Plan, etc.) is available. Applications must be submitted via the www.usajobs.gov website by searching for announcement numbers: NIH-CC-DE-19-10532541 and/or NIH-CC-MP-19-10533300 for Investigational New Drug Specialist (IND). Applications must be submitted by the closing date of the announcement (Monday, August 19th – Friday, August 23rd). Please include in your Cover Letter a description of mentoring and outreach activities in which you have been involved, especially those involving persons from groups which are underrepresented in biomedical research. If you have questions about this position, please contact Jacquara Graham at (301) 435-4752 or firstname.lastname@example.org. This position is subject to a background investigation.
The Department of Health and Human Services and NIH are equal opportunity employers committed to equity, diversity and inclusion.
Candidates must have a bachelors degree or graduate/higher level degree with major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of this position. (This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained) and 1 (one) year of qualifying specialized experience equivalent to the next lower grade of the position.
The ideal candidates will possess at least 5 years experience in Investigational New Drug Applications (INDs) and Investigational Device Exemptions (IDEs) regulatory support and comprehensive knowledge of FDA regulations and the approval process of INDs and IDEs.