BASIC QUALIFICATION REQUIREMENT
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.
2. Select one response that demonstrates how you meet the Additional Qualification requirement for the GS-13 grade level of 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.
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.
SECTION II. CERTIFICATION OF INFORMATION ACCURACY
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.