Job Listing
Regulatory Scientific Reviewer
Food and Drug Administration · Posted 46 days ago
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 $171,700-$280,658..
What You'll Do
- →Performs comprehensive clinical and scientific evaluations of a broad range of regulatory submissions.
- →Provides guidance to sponsors across all phases of product development, ensuring that clinical protocols are scientifically sound, ethically appropriate, and capable of generating data to support approval or clearance.
- →Leads and contributes to the development of clinical guidelines, regulatory policies, and Federal Register publications, while collaborating with multidisciplinary teams, advisory committees, and other Centers.
- →Applies advanced clinical judgment to evaluate trial methodology, safety signals, product labeling, and post-marketing requirements, ensuring continued safety and effectiveness throughout the product lifecycle.
- →Conducts in-depth reviews of preclinical and translational data to determine readiness for human trials; assessing pharmacovigilance data, adverse event reports, and real-world evidence to identify emerging safety concerns Evaluates statistical analyses and endpoints in collaboration with biostatisticians to ensure robustness of clinical evidence.
- →Determines if human subjects in clinical research of investigational new drugs or biologics can be protected from unreasonable risks.
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: f3832d39-d6b4-41e8-b9e1-c99472f525a2
Posted via USAJobs