Supervisory Regulatory Counsel, GS-301-15

Vacancy ID: 778500   Announcement Number: HHS-FDA-CBER-MP-13-778500   USAJOBS Control Number: 330237100

Occupational/Assessment Questions:

1. Do you have at least one full year of specialized experience (equivalent to the GS-14 grade level or higher in the Federal service) that included overseeing or managing compliance activities of biological products; developing policies and procedures for a regulated program; collaborating with program senior managers and advising on matters in the area of regulatory compliance; and providing supervision/leadership to a staff or team members?

A. Yes (this specialized experience must be reflected in your resume)
B. My experience is not described in the above question.

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. Address and resolve regulatory and compliance issues for a program by developing methodologies, procedures, and guidelines.

3. Conduct legal/administrative action reviews for deviation from the applicable standards and regulations.

4. Ensure policy and guidance is consistent among inspection, enforcement, and regulatory programs.

5. Develop effective and financially secured methods to conduct the regulatory evaluation of biological products.

6. Prepare implementation plans of proposed regulatory changes having an impact on a scientific program.

7. Ensure short- or long-term goals and strategies are being achieved within various program offices.

8. Address and resolve unusual and often precedent setting issues associated with regulated programs.


9. Recommend training for employees to enhance their work performance and skills.

10. Resolve informal complaints from employees to minimize any negative impacts.

11. Conduct performance appraisal meetings and provide constructive feedback to employees.

12. Plan and assign work to team members or employees based on skill level and capabilities.

13. Make recommendations for selections, promotions, or reassignments of employees.

14. Facilitate meetings to discuss and make decisions regarding regulatory/compliance issues within a program.

15. Provide authoritative advice and consultation in the area of regulatory processes and procedures.

16. Collaborate with representatives such as Congress, Federal agencies, state, local, and foreign governments, regulated industries, industry organizations, and public interest groups.

17. Develop guidance to improve the administration activities of a project team.

18. Write procedures, policies, and/or guidance to clarify and improve a scientific program's operations.

19. Prepare written replies to legal correspondence.

20. Prepare reports based on scientific findings for publication.