Lead Clinical Analyst

Vacancy ID: 809573   Announcement Number: HHS-FDA-CDER-MP-13-809573   USAJOBS Control Number: 334297700

Occupational/Assessment Questions:

Please respond to each of the following questions. For each question, choose the response that best describes your experience and training. Mark only one response for each question. Please note that your answers will be verified against the information provided in your resume, your application, and information provided by your references.

1. Do you possess a bachelor's degree with major study in an academic field related to the health sciences or allied sciences appropriate to the work of the position?

A. Yes (You must submit a copy of your transcript at time of application submission).
B. No.

2. Do you have one or more years of specialized experience equivalent to the GS-14 Federal grade level that equipped you with the particular knowledge, skills, and abilities needed to successfully perform the duties of this Lead Clinical Analyst? Examples of specialized experience include evaluating clinical drug trial reports for evidence of safety; developing regulations, guidance documents, and procedures related to drugs labeled for use during pregnancy and lactation; and briefing team members and senior management on medical interpretations and conclusions.

A. Yes, this specialized experience is reflected in my resume.
B. No, my experience does not match the description above.

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.
B- I have limited experience in performing this work behavior. I have had exposure to this work behavior but would require additional guidance, instruction, or experience to perform it at a proficient level.
C- I have experience performing this work behavior across routine or predictable situations with minimal supervision or guidance.
D- I have performed this work behavior independently across a wide range of situations. I have assisted others in carrying out this work behavior. I seek guidance in carrying out this work behavior only in unusually complex situations.
E- I am considered an expert in carrying out this work behavior. I advise and instruct others in carrying out this work behavior on a regular basis. I am consulted by my colleagues and/or superiors to carry out this work behavior in unusually complex situations.

3. Analyze data from industry sponsored pre- and post-marketing pharmacokinetic, clinical lactation, and safety studies.

4. Evaluate protocols from industry sponsored pre- and post-marketing pharmacokinetic, clinical lactation, and safety studies.

5. Evaluate case reports and epidemiological studies of possible drug-induced adverse pregnancy outcomes or effects in human milk-fed infants.

6. Evaluate clinical trial reports in humans for evidence of safety of the new drug substance to obtain marketing approval for drug products.

7. Coordinate maternal health training for staff members.

8. Develop regulations, guidance documents, and procedures related to drugs labeled for use during pregnancy and lactation.

9. Advise senior level staff on broad policy and strategic initiatives related to the scientific review of pre- and post-marketing studies in the area of medical or scientific research as they related to the risk of non-obstetric drugs on pregnant women and developing fetuses.

10. Contribute to center level and inter-center level discussions and meetings by participating in discussions regarding congressional inquiries and policy development.

11. Provide responses to Congressional inquiries on the formulation and development of policy.

12. Convene meetings between appropriate parties such as professional organizations, industry, academic institutions, other regulatory agencies, and the public to gather information and explore issues surrounding drug development and drug labeling for use during pregnancy and lactation.

13. Represent the organizations on issues related to the review of drug products and labeling for use during pregnancy and lactation.

14. Serve as an expert resource for advice and training on the review and approval of drugs and their potential use in pregnancy and during lactation.

15. Brief team members and senior management on medical/scientific interpretations and conclusions.

16. Review the work of team members on a regular and recurring basis.

17. Recommend informal performance ratings for team members.

18. Plan work to be performed by team members by assigning work, setting or adjusting short-term priorities, and preparing schedules for the completion of work.

19. Give advice, counsel, and instruction to team members on work matters.

20. Identify ways to improve production or increase the quality of work.

As previously explained, your ratings in this Occupational Questionnaire are subject to evaluation and verification based on the resume and documents you submit. Later steps in the selection process are specifically designed to verify your ratings. Deliberate attempts to falsify information may be grounds for not selecting you or for dismissing you from the position/agency during the probationary period, or other disciplinary action, including termination. Please take this opportunity to review your ratings to ensure their accuracy. By agreeing to the statement below, you are confirming that you: Understand this warning; have reviewed your responses to this questionnaire for accuracy; and verified that your responses accurately describe your current level of experience and capability.

21. Failure to agree or respond to the statement below will disqualify you from further consideration for the position. Select the most appropriate response below.

A. Yes, I verify that all of my responses to this questionnaire are true and accurate. I accept that if my supporting documentation and/or later steps in the selection process do not support one or more of my response to the questionnaire that my application may be rated lower 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.