Regulatory Counsel, GS-0301-11/12/13


Vacancy ID: 816276   Announcement Number: HHS-FDA-CDER-DE-13-816276   USAJOBS Control Number: 334633600

Occupational/Assessment Questions:

1. From the descriptions below, please choose the BEST answer that demonstrates your experience and/or education related to the GS-301-11 Regulatory Counsel position.

A. I have one year of specialized experience, equivalent to the GS-09 in the Federal service that included drafting legal documents, correspondence, pleadings and briefs for review; and analyzing and interpreting regulatory and scientific information.
B. I have a Ph.D. or equivalent doctoral degree; OR 3 full years of progressively higher level graduate education leading to such a degree; OR LL.M. (You must provide your transcript at time of application submission)
C. I have a combination of specialized experience and education (as noted in A and B above), which when combined, is equivalent to 100% of the qualification requirement. (You must provide your transcript at time of application submission)
D. My experience and/or education is not reflected in choice A, B, or C above.

2. From the descriptions below, please choose the BEST answer that demonstrates your experience related to the GS-301-12 Regulatory Counsel position.

A. I have one year of specialized experience, equivalent to the GS-11 in the Federal service that included providing advice and counsel on statutes and regulations affecting technical regulatory programs such as food and drug, healthcare, or other complex technical regulatory programs; drafting legal documents such as pleadings in court, briefs, legal opinions, and legal memoranda for review; and participating in working groups of regulatory, scientific, and legal experts to develop recommendations to regulatory and scientific issues.
B. My experience is not reflected in choice A above.

3. From the descriptions below, please choose the BEST answer that demonstrates your experience related to the GS-301-13 Regulatory Counsel position.

A. I have one year of specialized experience, equivalent to the GS-12 in the Federal service that included providing authoritative advice on statutes and regulations affecting technical regulatory programs such as food and drug, healthcare, or other complex technical regulatory programs; writing complex legal documents such as pleadings in court, briefs, legal opinions, and legal memoranda for a regulatory or compliance program; leading working groups of regulatory, scientific, and legal experts to develop recommendations to regulatory and scientific issues; and presenting regulatory information at conferences and professional meetings.
B. My experience is not reflected 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.

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

5. Review comments on proposed regulations.

6. Interpret draft regulations concerning medical policy products or other complex regulatory programs.

7. Participate in resolving a broad range of regulatory, scientific, and technical issues.

8. Conduct legal analyses involving statutes, regulations, policies, and procedures.

9. 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.

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

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

12. Advise clients on procedures and methods for implementing regulations and policy statements.

13. Provide regulatory and technical support for assigned projects and programs.

14. Inform colleagues on new and/or existing trends in the pharmaceutical and health care industries.

15. Present regulatory or compliance issues to a varied audience.

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.

19. Draft or review documents embodying policy and program proposals and decisions on these issues.