Regulatory Counsel, GS-301-14


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

Social Security Number


Vacancy Identification Number

888938
1. Title of Job

Regulatory Counsel, GS-301-14
2. Biographic Data

3. E-Mail Address


4. Work Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

5. Employment Availability

If you are applying by the OPM Form 1203-FX, leave this section blank.

6. Citizenship

Are you a citizen of the United States?
7. Background Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

8. Other Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

9. Languages

If you are applying by the OPM Form 1203-FX, leave this section blank.

10. Lowest Grade


14

11. Miscellaneous Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

12. Special Knowledge

If you are applying by the OPM Form 1203-FX, leave this section blank.

13. Test Location

If you are applying by the OPM Form 1203-FX, leave this section blank.

14. Veteran Preference Claim

15. Dates of Active Duty - Military Service

16. Availability Date

If you are applying by the OPM Form 1203-FX, leave this section blank.

17. Service Computation Date

If you are applying by the OPM Form 1203-FX, leave this section blank.

18. Other Date Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

19. Job Preference

If you are applying by the OPM Form 1203-FX, leave this section blank.

20. Occupational Specialties

Read the statements below to determine what options (001 and 002) you are eligible to apply.  You must enter at least one code.

001 - Merit Promotion:  I am eligible to be considered under merit promotion procedures because I am a current or former Federal employee working in a permanent competitive service position; or I am a veteran with preference; or I am a veteran who has been honorably discharged and substantially completed at least 3 years of continuous active duty service. (You must submit documentation to support your eligibility.)

002 - Noncompetitive: I am eligible to be considered under this specialty code because I meet the requirements for a noncompetitive appointment. Examples of non-competitive appointing authorities may include but not limited to: 30% or more compensable disabled veterans, Persons with Disabilities (Schedule A), PHS Commissioned Officer, Veterans’ Recruitment Appointment (VRA) [for positions up to the GS-11 Federal level], Peace Corps employees, current/former Federal employees who currently hold or previously held a Federal competitive position with promotion potential at or above the full performance level listed for this position, and a current Federal employee working in an excepted service position covered by an Interchange Agreement. (You must submit documentation to support your eligibility for noncompetitive appointment).


 


001 Merit Competitive
002 Noncompetitive

21. Geographic Availability


241450031 Silver Spring, MD

22. Transition Assistance Plan

23. Job Related Experience

If you are applying by the OPM Form 1203-FX, leave this section blank.

24. Personal Background Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

25. 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.