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Enter the lowest grade level that you will accept for this position. The lowest grade for this position is 15.
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1. From the descriptions below, please choose the BEST answer that describes your education and meets the Basic Qualifications Requirement for Supervisory Regulatory Health Project Manager, GS-0601-15.A. I have a bachelor's degree in a major study in an academic field related to the health sciences or allied sciences appropriate to the work of the position. (You must submit your transcript at time of application submission).
2. From the descriptions below, choose the BEST answer that demonstrates your experience related to this position.A. I have at least one year of specialized experience, equivalent to the GS-14 grade level in the Federal service that included providing authoritative advice on the regulations, legislation, and administrative procedures involved in regulatory science-based product review; performing the full range of project management duties related to the product review process; and planning and organizing the work multi-disciplinary review teams.
In this section, you are asked to evaluate yourself on task items using the scale provided. When marking your ratings, please do not overstate or understate your level of experience or capability. You should be aware that your ratings are subject to evaluation and verification. Do not give yourself credit for having performed tasks you have not performed. Additional steps in the selection process are designed to verify your stated level of experience and capability. Deliberate attempts to falsify information will be grounds for not selecting you or for dismissing you from employment with the organization.A- I have not had education, training or experience in performing this task.
3. Interpret and apply scientific, technical and regulatory documents including protocols, procedures and policies.
4. Initiate communications or correspondence regarding scientific findings and science-based recommendations, actions and decisions.
5. Advise the Office of Director and other key officials on scientific regulatory project manager application review issues that have impact on policy.
6. Work collaboratively with members of a team to develop and complete projects.
7. Establish and maintain cooperative relationships with team members to identify and recommend solutions to problem areas.
8. Work through and with others to maximize each person's contribution, foster an open exchange of ideas, and timely resolution of conflicts.
9. Provide leadership and managerial direction to staff engaged in a variety of activities related to planning, development, execution and coordination of regulatory project management and application review.
10. Plan and assign work to be performed by subordinates, set and adjust both short-term and long-term priorities, and prepare schedules for completion of work.
11. Evaluate work performance of subordinates.
12. Interview candidates for positions and makes selections for appointment, promotion, or reassignment of employees.
13. Hear and resolve group grievances and employee complaints.
14. Arrange for training to meet the development needs of staff.
15. Analyze situations, anticipate and identify obscure obstacles, and suggest courses of action to address complex issues in FDA regulation of products.
16. Develop policies and procedures to implement legislative and regulatory requirements.
17. Critically reviews documents for compliance with all legal, regulatory, and policy requirements.
18. Provide leadership and training to staff regarding FDA regulation.
19. Provide authoritative advice and counsel to FDA management and other interested parties regarding scientific and regulatory review issues that impact FDA policy and goals.
20. Manage the product review process from initial submission to time of Agency action.
21. Extend and modify approaches, precedents and methods to resolve a variety of regulatory health project management problems.
22. Develop project plans including milestones and deliverables.
23. Prepare briefing materials for meetings.
24. Prepare written memoranda and correspondence for signature by higher-level officials.
25. Prepare papers, reports and other documentation on best practices or innovative approaches to address challenges in regulatory science.
26. Explain and interpret policies, procedures and guidance.
27. Provide input on program planning and management decisions.
28. Provide information to staff and management on policies, guidelines and regulatory issues.