Job Listing
Regulatory Scientific Reviewer (Pharmacist)
Food and Drug Administration · Posted 2 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 1, Band D.
What You'll Do
- →Applies expertise in drug formulation, labeling, stability, compounding, drug interactions, and medication use to evaluate the quality, safety, and appropriate use of pharmaceutical products across diverse patient populations.
- →Utilizes knowledge of pharmaceutical sciences and clinical pharmacy practice to support science-based assessments of drug products, manufacturing standards, and medication-related policies.
- →Coordinates assignments with interested parties internal and external to the Agency and integrates it into the broader regulatory programs of the FDA.
- →Advises on area specific research, product specific inspections, or product release responsibilities.
- →Assures that legal and policy considerations are adequately addressed, as well as purely technical matters.
- →Coordinates hearings required in connection with assignments, as appropriate.
- →Serves as an Agency spokesperson and authoritative source of information and advice on matters related to the assigned area of responsibility.
- →Develops guidelines or criteria for scientific review and approval for a class of products.
- →Provides authoritative review or coordination of review of important precedent setting scientific issues which establish Agency policy for subsequent reviews of similar products.
- →Publishes scientific articles within the scientist's area of expertise in the open literature.
- →Develops new rules concerning a class of products, preparing these rules for publication in the Federal Register.
- →Represents and speaks for the Agency at national professional conferences.
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: 35efff82-fde1-446e-8b9f-14d10a8232ec
Posted via USAJobs