Regulatory Counsel, GS-301-14


Vacancy ID: 888938   Announcement Number: HHS-FDA-MP-13-888938   USAJOBS Control Number: 343463200

Occupational/Assessment Questions:

1. Carefully review the responses below, and select the item that best describes your experience as it pertains to the minimum requirements for this position. You must respond to this question and submit a résumé that clearly describes your related experience to be considered.

A. I have at least one full year of specialized experience (equivalent to the GS-13 grade level or higher in the Federal service) that included analyzing, evaluating, and applying complex statutes and regulations affecting technical regulatory programs such as food and drug,healthcare, environmental, or other complex technical regulatory programs; drafting legal documents such as pleadings in court, briefs, legal opinions, and legal memoranda; and participating in working groups of scientific, regulatory, and legal experts to develop recommendations.
B. My experience is not described in choice A 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.

2. Provide legal advice to  and/or counsel agency staff or private entities.

3. Advise clients on legal issues concerning the regulation of drug products or other complex regulatory programs.

4. Review or draft comments on proposed regulations.

5. Interpret regulations concerning drug products or other complex regulatory programs.

6. Conduct legal analyses involving complex statutes, regulations, policies, and procedures.

7. Provide advice on the legal sufficiency and procedural adequacy of proposed policies and initiatives.

8. Use resources (e.g. Westlaw, LexisNexis, MediRegs, the US code, the Code of Federal Regulations, the Federal Register, and etc.) to conduct legal research regarding established precedents in order to develop and support legally sufficient documents.

9. Handle complex and difficult assignments of national scope and significance.

10. Resolve complex issues concerning the application of food and drug enabling statutes, regulations, or other laws affecting complex regulatory programs.

11. Advise program offices or private clients on procedures and methods for implementing regulations and policy statements.

12. Lead working groups of scientific, regulatory, and legal experts to develop policy recommendations.

13. Provide advice and/or training to senior regulatory specialists and/or other professionals.

14. Provide advice on the interpretations of the laws, regulations, and policies affecting the organization.

15. Prepare written legal analyses of complex technical statutes, regulations, policies, and procedures.

16. Prepare legal pleadings such as affidavits, briefs, motions for summary judgment and dismissal.

17. Draft comments on proposed legislation.

18. Prepare written replies to legal correspondence.