Vacancy ID: 858099   Announcement Number: HHS-FDA-CDER-MP-13-858099   USAJOBS Control Number: 340060400

Occupational/Assessment Questions:

1. Please select the response below that best indicates how you meet the basic education requirement for a Pharmacologist position. Remember, if your answer is 'A' below, you MUST provide a copy of your college transcript (official or unofficial) or a list of college courses showing the name of the institution attended, grade received and semester/quarter hours completed to document how you meet this requirement. Failure to submit appropriate education verification will result in an ineligible rating.

A. I have a bachelor's degree or higher in an appropriate 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. (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.) Transcript(s) must be submitted with application package prior to the close date of the announcement.
B. I do not have education as listed above; therefore I do not qualify for this position.

2. Select one response that demonstrates how you meet the Additional Qualification requirement for the GS-14 grade level of this position.

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/bioequivalence study data.

B. I do not meet the additional qualification requirement defined in response A and do not qualify for this position.

For the following questions, choose ONE statement from the list (A through E) below that best describes your HIGHEST level of work experience in the task. Your answers to these task statements must be supported by your resume or your score may be lowered.

A- I do not have experience in performing this task.
B- I have had education or training in performing this task, but have not yet performed it on the job.
C- I have performed this task on the job. My work on this task was monitored closely by a supervisor or senior employee to ensure compliance with proper procedures.
D- I have performed this task as a regular part of a job. I have performed it independently and normally without review by a supervisor or senior employee.
E- I am considered an expert in performing this task. I have supervised performance of this task or I am normally the person who is consulted by other workers to assist them in doing this task because of my expertise.

3. Review Abbreviated New Drug Applications (ANDAs) focusing on in vivo bioequivalence evaluation of generic drugs when used according to dosage indications in the labeling.

4. Consult on study design and other scientific issues related to pharmacology, bioequivalence and in vitro dissolution methods.

5. Apply new developments and theories to critical and novel problems.

6. Extend and modify approaches, precedents and methods to solve a variety of problems with unprecedented and obscure aspects.

7. Submit substantive regulatory recommendations and conclusions for concurrence by the scientific supervisor.

8. Evaluate the results of human or in vitro pharmacology or pharmacokinetic studies submitted by a drug applicant in support of INDs or ANDAs, amendments, supplements and other related scientific submissions.

9. Evaluate the results of the pharmacokinetics and biopharmaceutic analysis studies submitted for the study of generic drugs.

10. Review and evaluate the results of pharmacokinetics and biopharmaceutic analyses of studies.

11. Summarize data reviewed for in vivo approval.

12. Meet with industry representatives to exchange information and to provide advice and guidance regarding those aspects of the application, notice, amendment, supplement or report which fall within area of review.

13. Attend meetings, conferences, and symposia of scientific organizations to remain aware and gain an understanding of developments in the field.

14. Participate in professional committees and working groups.

15. Maintain communication with industry representatives on recommendations to the generic drug industry regarding bioavailability/bioequivalence study data.

16. Prepare written summaries of in vivo bioequivalence studies for approval or non-approval.

17. Provide consultative service to other centers as well as other agencies within the Government.

18. Provide guidance to industry representatives on bioavailability/bioequivalence study data, including review findings

19. Provide new guidance in order to keep abreast of current trends relative to work assignments.

20. Your responses in this Assessment Questionnaire are subject to evaluation and verification.  Later steps in the selection process are specifically designed to verify your responses.  Deliberate attempts to falsify information may be grounds for disqualifying you or for dismissing you from employment following acceptance.  Please take this opportunity to review your responses to ensure their accuracy.  By agreeing to the statement below, you are confirming that you have reviewed your responses to this questionnaire for accuracy, and verify that your responses accurately describe your current level of experience and capability.

Failure to agree to the statement below will disqualify you from further consideration for this position.

A. Yes, I verify that, to the best of my knowledge and belief, all of the information included in this questionnaire is true, correct, and provided in good faith. I accept that if my supporting documentation and/or later steps in the selection process do not support one or more of my responses to the questionnaire that my rating may be lowered and/or I may be removed from further consideration.

B. No, I do not accept this agreement and/or I no longer wish to be considered for this position.