Senior Regulatory Health Project Manager


Vacancy ID: 806751   Announcement Number: HHS-FDA-CTP-DE-13-806751   USAJOBS Control Number: 333508900

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 806751
1. Title of Job

Senior Regulatory Health Project Manager
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

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10. Lowest Grade

Enter the lowest grade level that you will accept for this position. The lowest grade for this position is 14.


14

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

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18. Other Date Information

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19. Job Preference

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20. Occupational Specialties

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


001 Senior 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

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23. Job Related Experience

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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, select the one which best describes your education and/or experience and meets the Minimum Qualification Requirements for Senior Regulatory Health Project Manager, GS-0601-14.

A. I have one year of specialized experience, equivalent to the GS-13 grade level in the Federal service, to include specialize experience applying knowledge of scientific methods and of FDA regulations and policies to formulate and manage product research and review projects; applying management principles in planning and organizing concurrent activities and anticipating subtle and difficult issues; and providing oral and written briefings and recommendations concerning projects.
B. I do not meet the requirements as described above.

For each task in the following group, choose the statement from the list below that best describes your experience and/or training. Darken the oval corresponding to that statement in Section 25 of the Qualifications and Availability Form C. Please select only one letter for each item.

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 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 because of my expertise.

2. Review and evaluate scientific data, reports and proposals.

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. Perform library and document searches of technical and scientific publications for reply to interested parties.

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. Serve as project coordinator in the management of team activities, including developing and monitoring project milestones and overall team progress.

10. Communicate scientific and technical information orally and in writing, such as preparation of meeting minutes.

11. Identify and appraise team and management of potential barriers while coordinating the resolution of conflicting resource needs, availability and scheduling.

12. Analyze situations, identify obstacles, and suggest courses of action to address issues in FDA regulation of products.

13. Develop policies and procedures to implement legislative and regulatory requirements.

14. Maintain awareness of all relevant statutes, regulations, and policies relating to FDA regulation of assigned product area, and keep up-to-date on policy changes.

15. Provide leadership and training to staff regarding FDA regulation.