INTERDISCIPLINARY SCIENTIST, GS-14


Vacancy ID: 869597   Announcement Number: HHS-FDA-CDER-MP-13-869597   USAJOBS Control Number: 340991800

Social Security Number


Vacancy Identification Number

869597
1. Title of Job

Regulatory Counsel, GS-301-15
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

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

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


14

11. Miscellaneous Information

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

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

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

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

These position have multiple work schedules including full-time and part-time.  Please select the work schedule(s), full-time and/or part-time, that you are willing to accept.
01 Full-Time
02 Part-Time (25 hours per week)

20. Occupational Specialties

Select the option for the discipline(s) you want to be considered for:


001 Biologist
002 Microbiologist
003 Chemist

21. Geographic Availability


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. Are you a current Food and Drug Administration (FDA) Federal employee working in a permanent appointment?

A. Yes (you must submit an SF-50, Notification of Personnel Action)
B. No

2. Please choose the best response that indicates that you meet the basic requirements for a Biologist position.

A. I possess a degree in biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position (must submit transcript at time of application submittal).
B. I possess a combination of education and experience -- Courses equivalent to a major, as shown in A above, plus appropriate experience or additional education (must submit transcript at time of application submittal).
C. My education and/or experience are not reflected in choice A or B above.

3. Please choose the best response that indicates that you meet the basic requirements for a Microbiologist position.

A. I possess a degree in microbiology; or biology, chemistry, or basic medical science that included at least 20 semester hours in microbiology and other subjects related to the study of microorganisms, and 20 semester hours in the physical and mathematical sciences combining course work in organic chemistry or biochemistry, physics, and college algebra, or their equivalent (must submit transcript showing coursework at time of application submittal).
B. I possess a combination of education and experience -- courses equivalent to a major in microbiology, biology, chemistry, or basic medical science that included courses as shown in A above, plus appropriate experience or additional education (must submit transcript showing coursework at time of application submittal).
C. My education and/or experience are not reflected in choice A or B above.

4. Please choose the best response that indicates that you meet the basic requirements for a Chemist position.

A. I possess a degree in physical sciences, life sciences, or engineering that included 30 semester hours in chemistry, supplemented by course work in mathematics through differential and integral calculus, and at least 6 semester hours of physics (must submit transcript showing coursework at time of application submittal).
B. I possess a combination of education and experience -- course work equivalent to a major as shown in A above, including at least 30 semester hours in chemistry, supplemented by mathematics through differential and integral calculus, and at least 6 semester hours of physics, plus appropriate experience or additional education (must submit transcript showing coursework at time of application submittal).
C. My education and/or experience are not reflected in choice A or B above.

5. Do you have one year (52 weeks of full time employment) of specialized experience, equivalent to the GS-13 level in the Federal service, that included: serving as a scientific authority on regulatory and compliance concepts, methodologies, procedures, guidelines, and policies; reviewing and approving the development of regulations and guidance of a program office; leading and/or planning projects involving regulatory issues of pharmaceuticals, drug trials, or post marketing safety policies; preparing reports based on regulatory study results; and collaborating with external key officials or stakeholders on regulatory actions or issues?

A. Yes (this specialized experience must be reflected in your resume)
B. My experience is not reflected in the description above.

For each of the items below, select the one statement that most accurately describes your experience and capability using the scale below.

A- I have no experience in performing this work behavior.
B- I have limited experience in performing this work behavior. I have had exposure to this work behavior but would require additional guidance, instruction, or experience to perform it at a proficient level.
C- I have experience performing this work behavior across routine or predictable situations with minimal supervision or guidance.
D- I have performed this work behavior independently across a wide range of situations. I have assisted others in carrying out this work behavior. I seek guidance in carrying out this work behavior only in unusually complex situations.
E- I am considered an expert in carrying out this work behavior. I advise and instruct others in carrying out this work behavior on a regular basis. I am consulted by my colleagues and/or superiors to carry out this work behavior in unusually complex situations.

6. Advise on compliance regulations and other legal issues within a drug safety program.

7. Ensure regulations and guidance are well-written and consistent with all applicable legal/regulatory requirements.

8. Advise personnel of new regulations, legislation, and trends in the industry from a legal/regulatory perspective.

9. Resolve program segment regulatory issues.

10. Serve as a scientific authority on regulatory and compliance concepts, methodologies, procedures, guidelines, and policies.

11. Assign project work to team members.

12. Evaluate projects or program elements designed to achieve critical or key scientific and regulatory goals.

13. Develop valid plans and approaches for projects designed to address compliance issues.

14. Plan complex projects elating to pharmaceutical policies, drug trials, or post marketing drug safety.

15. Represent a program in discussing controversial regulatory and scientific matters.

16. Serve as a scientific authority on regulatory and compliance concepts, methodologies, procedures, guidelines, and policies.

17. Present scientific information (e.g., data findings, observations, regulatory interpretations) at conferences and/or professional meetings.

18. Advise external stakeholders, consumers, and other counterparts on scientific, technical or regulatory issues impacting public health.

19. Prepare reports based on scientific findings relating to policies and procedures.

20. Draft proposals for new drug safety regulations and policy statements for a program.

21. Write procedures or guidance to improve program operations and processes.

22. Write correspondence in response to inquiries from agency officials, consumers, academia, and the regulated industry.