Senior Regulatory Health Project Manager, GS-601-14


Vacancy ID: 850901   Announcement Number: HHS-FDA-OND-13-850901   USAJOBS Control Number: 338791000

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 850901
1. Title of Job

Senior Regulatory Health Project Manager, GS-601-14
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?
This includes applicants who are eligible for special or noncompetitive appointment authorities such as 30% or more compensable disabled veterans, persons with disabilities and PHS Commissioned Corps Officers.  This also includes applicants who meet the qualifications for this position and who have previously held, or currently hold, a Federal position at the grade of this position.


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 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

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 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:


241450031 Silver Spring, 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 education and meets the Basic Qualification Requirements for Senior Regulatory Health Project Manager, GS-601-14.

A. Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's degree that included a major field of study in an academic field related to health sciences or allied sciences appropriate to the work of the position.
B. Combination of education and/or experience at the GS-13 level in the Federal service: examples of specialized experience are as follows: demonstrating use of regulations and administrative procedures involved in the product and drug development and review process; participating in the management and coordination of scientific projects and initiatives as well as planning, focusing and coordination of the teams activities.
C. I do not possess education and/or experience for this position.

2. Are you a current FDA employee within the Center for Evalutaion and Research (CDER), Office of New Drugs?

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 is normally the person who is consulted by other
workers to assist them in doing this task because of my expertise.

3. Managed industry compliance and tracking of all regulatory requirements of legislation including Food and Drug Administration Amendments Act (FDAAA) which made significant changes to the current drug review process, including authorizing FDA to require applicants to change product labeling, conduct post marketing studies, and authorizes civil penalties for non-compliance.

4. Assures Good Review Management Principles and Practices (GRMPPs) and Prescription Drug User Fee Act (PDUFA) goals and deadlines are met.

5. Manage and track each application while it is being reviewed by secondary and tertiary reviewers.

6. Plan and review 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.

7. Recommend re-evaluation of team membership and workload redistribution.

8. Monitor and report actual status of all activities within the assigned projects through interaction with project participants.

9. Serve as the primary point of contact for the up-to-date status of project progress and present the team activities to management.

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

11. Provide the authoritative advice and counsel to all parties engaged or interested in the drug review process concerning the assigned drug classes.

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

13. Serve as a driving force for the timely completion of project activities and attainment of project objectives within established project plans and performance goals set by the team.

14. Works with all members of the review team to develop project plans, including setting time frames, milestones and an agreed upon endpoint.

15. Serve as the contact point for all communications concerning applications in the assigned drug classes and ensuring compliance with all legal, regulatory and policy requirements.

16. Communicates directly with industry counterparts to resolve issues, facilitate technical information gathering for reviewers, and documenting regulatory requirements.

17. Correspond and documents regulatory requirements to Reviewers and applicants, as well as coordinates compliance with any review findings and recommendations.