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)
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.
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.