Regulatory Health Project Manager


Vacancy ID: 783542   Announcement Number: HHS-FDA-CT-13-783542   USAJOBS Control Number: 330789900

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 783542
1. Title of Job

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 an ICTAP Eligible?

For information on how to apply as an ICTAP eligible see http://opm.gov/rif/employee_guides/career_transition.asp#ictap.  To be well-qualified and exercise selection priority for this vacancy, displaced Federal employees must be rated at 85.0 or above on the rating criteria for this position.


Are you eligible for Indian preference as defined by the Department of the Interior (DOI) and as evidenced by appropriate Bureau of Indian Affairs (BIA) authorized certification?


Are you eligible for preference based on being a Public Law 94-437 Indian Health Service Scholarship recipient? For more information, please click here.    


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


Are you a PHS Commissioned Officer (This includes active duty officers, inactive reserve officers, and applicants who have been approved for commissioning in the USPHS Commissioned Corps)?


Are you eligible for noncompetitive appointment under a Special Appointing Authority (e.g. Veteran's Recruitment Appointment, present or former Peace Corps personnel, current Postal Service personnel, etc?


6. Citizenship

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

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

8. Other Information

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

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 13.


13

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

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

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

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

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 Competitive Promotion
002 Non-Competitive

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:


241679031 White Oak, MD

22. Transition Assistance Plan

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, select the one which best describes your experience and/or education which meets the Basic Qualification Requirements for Regulatory Health Project Manager-0601-13.

A. Yes. I have at least a bachelor's degree with a major study in an academic field related to the health sciences or allied sciences appropriate to the work of the position from an accredited college or university.
B. No. I do not possess the experience and/or education described above.

2. From the descriptions below, select the one which best describes your experience and meets the Additional Qualification Requirements for Health Scientist, GS-0601-14.

A. Yes. I have one year of specialized experience, equivalent to the GS-13 grade level in the Federal service, to include experience with program management, development of scientific projects/studies of public health information systems and programs, and the analysis and reporting of public health data.
B. No. I do not meet the requirements as described above.

3. This position is open to Federal Food and Drug Administration (FDA) employees with career or career-conditional appointments in the competitive service; former Federal employees with reinstatement eligibility based on previous career or career-conditional appointments; displaced Federal employees requesting special priority selection consideration under the Career Transition Assistance Plan (CTAP) and the Interagency Career Transition Assistance Program (ICTAP); veterans who are preference eligibles or who have been separated under honorable conditions after 3 years or more of continuous active service; individuals eligible for VRA appointments; and individuals with disabilities.

A. YES
B. NO

For each task in the following group, choose the statement from the list below that best describes your experience and/or training. 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 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 am normally the person who is consulted by other
workers to assist them in doing this task because of my expertise.

4. Manages the drug review process for one or more classes of drugs from initial submission to the time of approval, termination or withdrawal.

5. Acts as a driving force for the timely completion of project activities and attainment of project objectives.

6. Assures timely resolution of scientific and regulatory conflicts or problems to avoid delays in achieving goals.

7. Provides communication concerning applications in the assigned drug classes.

8. Initiates correspondence regarding action, policy issues or request for additional information.

9. Responds to requests for additional information and recommends solutions to problem areas.

10. Conveys opinions and decisions concerning application that may have major public health consequences.

11. Identifies project activities or situations that may adversely impact project plan and advising supervisor, team members and management of potential impact and, with the team, recommending solutions to problem areas.

12. Interfaces and interacts on a daily basic with other regulatory project managers and scientific reviewers in other FDA components.

13. Serves as the contact point for communications concerning applications in the assigned classes and Handles subject matters with broad, controversial and sensitive nature, and complex implications for FDA programs and the public health.

14. Manages and coordinates the work of the review team members for the specific drug application
Review to determine how much progress is being made and if any problems are surfacing.

15. Develops project plans, including setting time frames, milestones, and agrees upon endpoint.

16. Serves as a CO-Leader of the review team, responsible for the management of activities of the review team including scheduling meetings, and preparing issued-based agendas and official records of the meetings.

17. Identifes project activities that may adversely impact project plan and advise team members.

18. Coordinates completion of project activites with established project plans and performance goals set by the team.