Supervisory Interdisciplinary Scientist


Vacancy ID: 761319   Announcement Number: HHS-FDA-01-MP-13-761319   USAJOBS Control Number: 328183800

Social Security Number

Vacancy Identification Number

Enter 761319
1. Title of Job

Supervisory Interdisciplinary 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

If you are a male at least 18 years of age, born after December 31, 1959, have you registered with the Selective Service System?


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

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

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

15. Dates of Active Duty - Military Service

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

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

001 Biologist
002 Microbiologist
003 Toxicologist

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. From the description below, select the one which best describes your education and/or experience and meets the Basic Qualification Requirements for Supervisory Biologist, GS-0401.

A. Degree: biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position.
B. Combination of education and experience -- Courses equivalent to a major, as shown in A above, plus appropriate experience or additional education.
C. I do not possess the education and/or experience described above.

2. From the description below, select the one which best describes your education and/or experience and meets the Basic Qualification Requirements for Supervisory Microbiologist, GS-0403.

A. Degree: 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.
B. 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.
C. I do not possess the education and/or experience described above.

3. From the description below, select the one which best describes your education and/or experience and meets the Basic Qualification Requirements for Supervisory Toxicologist, GS-0415.

A. Degree: toxicology; or an appropriate discipline of the biological, medical, or veterinary sciences that included at least 30 semester hours in chemistry, biochemistry, or physiology,
B. I do not possess the education and/or experience described above.

4. From the description below, select the one which best describes your specialized experience and meets the Additional Qualification Requirements for Biologist, GS-401-14; Microbiologist, GS-403-14 and Toxicologist, GS-415-14.

A. I have one year of specialized experience, equivalent to at least the GS-13 level in the Federal Service, serving as a scientific or engineering reviewer, supervisor or senior advisor in the area of medical device evaluation as it relates to the review and evaluation of premarket notification submissions, premarket applications and/or investigational device exemptions for premarket approval prior to entry into the marketplace.
B. I do not possess the specialized experience described above.

5. Are you a permanent Food and Drug Administration employee?

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 or 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.

6. Manages a staff of scientists, engineers, CSOs and health care professionals in the administrative, regulatory and scientific review of pre-market notifications (510(k)s), IDEs, PMAs and reclassification petitions.

7. Provides technical leadership and judgment in the evaluation of complex issues involving devices which have a significant impact on the safety and effectiveness of various urology and lithotripsy medical devices or other medical device products.

8. Serves as a focal point, advisor and primary contact for medical device regulatory and scientific issues relative to various products/submissions.

9. Provides expert and authoritative advice, guidance, assistance, interpretations, consultations and recommendations to top level and senior Agency and Departmental officials, program directors, scientific and professional personnel and industry representatives.

10. Provides technical consultation of various medical device products.

11. Participates in technical work groups where the safety and effectiveness of urology and lithotripsy devices are discussed.

12. Plans and organizes activities of the Branch, such as review of reclassification petitions, premarket approval and/or research programs.

13. Serves as a technical expert and advisor in the area of preclinical and clinical testing of various medical device products as they relate to investigational device exemptions, premarket notifications and applications for premarket approval.

14. Coordinates the work of personnel which include Scientists, Engineers, Consumer Safety Officers, Health Care Professionals and support personnel in the administrative, regulatory and scientific review of pre-market notifications and petitions.

15. Provides guidance involving complex questions of opinion and policy.

16. Provides overall management and administrative direction to the clerical and professional staff.

17. Reviews and evaluates scientific activities in terms of achieving program goals and objectives and accomplishing assigned functional responsibilities.

18. Provides technical and clinical guidance to the staff on precedent setting and controversial issues involving complex questions of opinion and policy.

19. Represents the Division Director at various meetings, if necessary, with foreign manufacturers, health care professionals and government officials, and at international meetings.

20. Participates in inter-Agency task groups as an expert or senior reviewer and also participates in technical working groups in other Agencies or Centers.

21. Confers with industry officials and medical and/or scientific experts in the urology and lithotripsy device area or other medical device arena regarding the regulation of various device products.