Job Listing
Regulatory Scientific Reviewer
Food and Drug Administration · Posted 60 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
- →Complete preliminary clinical reviews, assignments and projects related to regulated products that have a national or international impact on health.
- →Review the safeguards for testing experimental and/or use of approved products in humans.
- →Review primary functions and activities concerned with labeling, advertising, post-market monitoring, adverse reaction evaluation, improvement of research and evaluation practices.
- →Maintain cutting edge expertise of the "state of science" to incorporate the most advance theories and practices in clinical medicine, into the Division's and Branch's pre-market review activities.
- →Evaluate plans and protocols to conduct tests and clinical trials of Investigation New Drugs (INDs) in humans, submitted to the Agency, and application amendments.
- →Evaluate clinical trial reports in humans for evidence of safety, immunogenicity, and effectiveness of new preventive vaccines and biotherapeutic products submitted in support of new Biologic License Applications (BLAs).
- →Provide advice and guidance regarding those aspects of the application which fall within the incumbent's area of review expertise.
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: c762dcf2-d527-48b6-98f3-20c8cef8a413
Posted via USAJobs