Regulatory Scientist


Vacancy ID: 783027   Announcement Number: HHS-FDA-MP-12-783027   USAJOBS Control Number: 330790000

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 783027
1. Title of Job

Regulatory Scientist
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 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

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 Regulatory Scientist

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 description below, select the one which best describes your education and meets the Basic Qualification Requirment.

A. Yes: Degree with a major of study in an academia field related to the health sciences or allied sciences appropriate to the work of the position.
B. No, I do not posses the education described above.

2. To qualify for the GS-15, in addition to basic education requirement, you must have one year specialized experience equivalent to the next lower grade in the Federal Service:  Examples of specialized experience at the GS-14 level are as follows: coordinates and manages the work of the team members for the specific scientific regulatory process, monitors and reports actual status of all life activities witin the assigned scientific regulatory proujects, provide authoritative advice and counsel.

A. Yes, I have one year of specialized experience described above equivalent to the next lower grade level in the Federal Service.
B. No, I do possess the one year of specialized experience described above for this position.

3. Are you a current career or career conditional employee within the Office of New Drugs (OND).

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. 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 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. Responsible for industry compliance with all regulatory requirements of FDA legislation including FDAAA.

5. Serves as the contact point for all communications concerning regulations, policies and procedures and ensures compliance with all legal, regulatory and policy requirements.

6. Provides authoritative advice and counsel to all parties engaged or interested in the FDA scientific regulatory process concerning the assigned area of study.

7. Responsible for ensuring the regulatory aspects of Good Review Management Principles and Practices (GRMPPs) and Prescription Drug User Fee Act (PDUFA) goals and deadlines are accomplished according to regulatory mandates.

8. Serves as the contact point for all communications concerning regulations, policies and procedures and ensures compliance with all legal, regulatory and policy requirements.

9. Responsible for the timely completion of project activities and attainment of project objectives regarding policy within established and specified regulatory plans and performance goals set by FDA and the team.

10. Initiates correspondence regarding action, policy issues or requests for additional information.

11. Directly manages and coordinates the work of the team members for the specific scientific regulatory process.

12. Develops project plans, including setting time frames, milestones and an agreed upon endpoint.