Vacancy ID: 778427   Announcement Number: HHS-FDA-CDER-DE-13-778427   USAJOBS Control Number: 331037100

Occupational/Assessment Questions:


1. Select one statement that demonstrates whether or not you meet the Basic Qualification requirement for this position. You must submit a copy of your college transcripts (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 possess a Bachelor's or higher degree 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.) I certify that I have submitted supporting documentation to verify my education as stated in the qualifications section of this vacancy.

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-13 grade level of this position.

A. I have at least one year of specialized experience equivalent to the GS-12 grade level in the federal Government (can be obtained in the public or private sector); performing all of the following: 1) applying a proficient working knowledge of the principles, theories, and practices of pharmacokinetics and therapeutics in humans; 2) utilizing a working knowledge of processes by which drug products are selected, prescribed, dispensed, administered and self-administered by a variety of health-care professionals and patients; 3) reviewing information regarding the dosage form, dissolution and labeling of proposed drug products; 4) recommending the acceptability of bioavailable/bio equivalency data; 5) working knowledge of federal laws, regulations, and guidelines pertaining to the safe and effective use of drug products; and 6) communicating verbally and in writing in order to exchange information with industry representatives and prepare comprehensive summaries of data reviewed. I certify that my resume fully demonstrates my knowledge, skills and abilities to perform the work of this position.

B. I do not meet the 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 information regarding the dosage form, dissolution and labeling of proposed drug products to evaluate their effectiveness.

4. Review and evaluate the results of pharmacokinetics and biopharmaceutical analyses of studies conducted using generic drugs.

5. Review and evaluate results of analysis of pharmacokinetic studies/submissions by sponsors in support of abbreviated new drug applications (ANDA).

6. Review and evaluate ANDA's focusing on in vivo bioequivalence evaluation of generic drugs when used according to the indications of dosage regiments in the labeling.

7. Conduct preclinical pharmacokinetic and biopharmaceutical studies

8. Design and implement preclinical pharmacokinetic and biopharmaceutical studies.

9. Review and evaluate the results of pharmacokinetics and biopharmaceutical analyses of studies submitted.


10. Review pharmacological and toxicological data in order to evaluate the efficacy seen in bio equivalency studies.

11. Interpret pharmacokinetic analysis of in-vivo bioavailability/bio equivalency of studies.

12. Evaluate pharmacokinetic data utilizing statistical methods.

13. Evaluate dissolution data submitted in support of abbreviated new drug applications.

14. Evaluate the suitability of the study design, assay methodology and sensitivity of assay methods.

15. Evaluate changes in formulation or bio equivalency data for any potential difference in clinical effect.

16. Review protocols of bioavailability/bio equivalency studies to ensure protocols meet bio equivalency requirements.

17. Review bio equivalency studies to demonstrate equivalency of the test product to pioneer drugs.

18. Assist in determining whether waiver of in-vivo bioavailability/bioequivalence studies can be granted for a drug product.


19. Summarize data reviewed for in vivo approval.

20. Submit final form recommendations and conclusions for approval.

21. Prepares comprehensive written summaries of in vivo bioequivalence studies and makes recommendations based on pharmacokinetic data.

22. Prepare written reviews and recommendations of bio equivalency protocols and studies.

23. Compile data to prepare periodic and special reports or manuscripts for publication in professional scientific journals.


24. Meet with industry representatives to exchange information and to provide advice and guidance.

25. Establish and maintain contacts with personnel in other offices to review problems, advice or seek advice on issues.

26. Explain and support agency recommendations to the generic drug industry regarding matters concerning bioavailability/bio equivalency study data.

27. Participate in conferences with team members of the office to discuss problems pertaining to matters under the responsibility of an organization.

28. Analyze data and present findings to scientific audiences and the general public.

29. Influence or motivate industrial representatives who are skeptical, uncooperative of differing and conflicting opinions.

30. Meet with representative of drug firms to exchange information and to provide advice and guidance or explanations of bioavailability/bioequivalence findings.

31. Persuade, justify, defend, or settle matters involving significant or controversial issues.


32. 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.