Supervisory Regulatory Health Project Manager, GS-601-15


Vacancy ID: 853854   Announcement Number: HHS-FDA-CTP-DE-13-853854   USAJOBS Control Number: 339333200

Social Security Number

Enter your Social Security Number in the space indicated. Your Social Security Number is requested under the authority of Executive Order 9397 to uniquely identify your records from those of other applicants who may have the same name.  As allowed by law or Presidential directive, your Social Security Number is used to seek information about you from employers, schools, banks and others who may know you. Providing your Social Security Number is voluntary, however we can not process your application without it.


Vacancy Identification Number

Enter 853854
1. Title of Job

Supervisory Regulatory Health Project Manager, GS-601-15
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

Are you eligible for the Federal Employment Program for Persons with Disabilities? (For information on Schedule A appointments, see the OPM website.)


6. Citizenship

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

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8. Other Information

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9. Languages

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

10. Lowest Grade

Enter the lowest grade level that you will accept for this position. The lowest grade for this position is 15.


15

11. Miscellaneous Information

If you are a male at least 18 years of age, born after December 31, 1959, have you registered with the Selective Service System?


01 Yes
02 No
03 Not Applicable

12. Special Knowledge

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

13. Test Location

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14. Veteran Preference Claim

15. Dates of Active Duty - Military Service

16. Availability Date

17. Service Computation Date

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

18. Other Date Information

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19. Job Preference

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

20. Occupational Specialties

Select/enter at least one occupational specialty. The specialty code for this position is:


001 Supervisory Regulatory Health Project Manager

21. Geographic Availability

Select/enter at least one geographic location in which you are interested and will accept employment. The location code for this position is:


241360031 Rockville, MD

22. Transition Assistance Plan

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

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. 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).
B. I do not possess the education described above.

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.
B. I do not possess the experience described above.

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.
B- I have had education or training in performing the task, but have not yet performed it on the job.
C- I have performed this task on the job. My work on this task was monitored closely by a supervisor or senior employee to ensure compliance with proper procedures.
D- I have performed this task as a regular part of a job. I have performed it independently and normally without review by a supervisor or senior employee.
E- I am considered an expert in performing this task. I have supervised performance of this task or is normally the person who is consulted by other workers to assist them in doing 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.