Job Listing
Physician (Regulatory Scientific Reviewer)
Food and Drug Administration · Posted 64 days ago
Hybrid Silver Spring, MD $172K – $281K Apply by Jul 20, 2026 Medical Officer ESTJINTJINTPISTJ Healthcare
Apply for this job → About the Role
This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 3, Band C. (GS-14 equivalent)
What You'll Do
- →Performs comprehensive clinical and scientific evaluations of a broad range of regulatory submissions, INDs, IDEs, BLAs, PMAs, and 510(k)s, assessing clinical trial design, safety, efficacy, and benefit-risk to support regulatory decision-making.
- →Leads and contributes to the development of clinical guidelines, regulatory policies, and Federal Register publications, while collaborating with multidisciplinary teams, advisory committees to resolve complex scientific and regulatory issues.
- →Preparing high-level briefing materials for senior leadership, responding to Congressional and public inquiries, and representing the Agency in national and international scientific, regulatory, and public health forums.
- →Evaluates complex statistical analyses and endpoints in collaboration with biostatisticians to ensure robustness of clinical evidence.
- →Coordinates and leads interactions with sponsors, including formal meetings pre-IND, end-of-phase, pre-submission), providing clear regulatory and clinical recommendations.
- →Participates in inspections and compliance activities where clinical expertise is required and contributes to enforcement decisions when safety or regulatory concerns arise.
- →Identifies and analyzes areas for new policies to be formulated and developed with expanded the types of biological products entered into clinical studies, including studies of gene and cellular therapy products.
Requirements
- ✓Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required.
- ✓Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.
- ✓TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements.
- ✓You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.
- ✓Education must be accredited by an accrediting institution recognized by the U.S.
- ✓Department of Education in order for it to be credited towards qualifications.
- ✓Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S.
- ✓Department of Education.
- ✓If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements.
- ✓Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file.
- ✓Therefore, you should consider asking the institution to provide the file in a non-secured electronic format.
- ✓Alternatively, you could scan or take a photo of the printed copy of the transcript.
- ✓If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access.
- ✓For further information, visit the U.S.
Personality Fit
Job ID: e584e604-9d78-4a50-a8f5-20dd558cca44
Posted via USAJobs