1. This position is open to current, permanent Federal employees of the Food and Drug Administration's Center for Drug Evaluation and Research (CDER). To be considered for this position, you must respond to this question and submit a Standard Form 50 - Notification of Personnel Action with your application demonstrating that you are a CDER employee who meets time-in-grade and appointment eligibility requirements.
Are you a current employee of the FDA's Center for Drug Evaluation and Research (CDER)?
2. Please read the following statements carefully and select the one response that best describes your education as it pertains to the Basic Requirement for this position. You must respond to this question and submit transcripts with your application to receive consideration for this position.A. I have a bachelor's or higher degree in biological, medical, veterinary, or physical science, or in pharmacy that included at least 30 semester hours in chemistry and physiology and 12 semester hours in pharmacology. I have submitted transcripts with my application to support this response. (Courses in chemistry, organic chemistry, biochemistry, general physiology, and animal, human, microbial, or cellular physiology may be used to meet the 30-semester hour requirement in chemistry and physiology. Courses in pharmacology, pharmacodynamics, pharmacotherapy, molecular pharmacology, and other similar subjects may be used to meet the 12-semester hour requirement in pharmacology. Courses dealing intensively with pharmacologically-oriented subjects may also be used to meet this requirement.)
3. Select the statement that describes how you meet the Specialized Experience for this position at the GS-14 level.A. I have at least one year of specialized experience (equivalent to the GS-13 grade level or higher in the Federal service) providing authoritative pharmacology and regulatory guidance for the review of Abbreviated New Drug Applications and Investigational New Drug Applications, with a focus on in vivo bioequivalence evaluation of generic drugs; analyzing scientific studies, and their results, related to pharmacokinetics and biopharmaceutics; developing summaries of data reviewed, including conclusions and recommendations; and advising drug sponsors/applicants on the acceptance and implementation of recommendations based on the review of bioavailability/bioequivalency study data.
For each of the items below, select the one statement that most accurately describes your experience and capability using the scale below.A- I have no experience in performing this work behavior.
4. Evaluate the results of the pharmacokinetics and biopharmaceutic analysis studies submitted for the study of generic drugs.
5. Review Abbreviated New Drug Applications (ANDAs) focusing on in vivo bioequivalence evaluation of generic drugs when used according to dosage indications in the labeling.
6. Analyze the possible adverse effects of drugs upon the processes of reproduction and on offspring.
7. Evaluate the results of non-clinical pharmacological and toxicological studies submitted by the drug sponsor/applicant in support of INDs, NDAs, BLAs amendments, supplements, and other related scientific submissions.
8. Consult on the toxicological potential of drugs in support of proposed clinical studies or proposed dosage regimens in labeling.
9. Advise on labeling as it pertains to animal studies and probable safety in use of the drug.
10. Provide guidance to industry representatives on bioavailability/bioequivalency study data, including review findings.
11. Provide training to reviewers through peer review seminars on precedent setting review, findings and/or training seminars on regulatory or scientific issues.
12. Prepare summaries and integrated discussions of data submitted for review.
13. Develop reports on the adequacy of animal data supporting INDs, the potential risk, and statements in the non-clinical sections of the proposed labeling.
14. Prepare written summaries of in vivo bioequivalence studies for approval or non-approval.
15. Interpret guides (e.g., scientific texts and technical references) to develop guides on pharmacology and toxicology for a scientific staff.