INTERDISCIPLINARY SCIENTIST


Vacancy ID: 819641   Announcement Number: HHS-FDA-13-MP-819641   USAJOBS Control Number: 335048700

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 819641
1. Title of Job

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

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 12.


12
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 status
002 status
003 status
004 status
005 status

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:


241360031 Rockville, 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:

Thank you for your interest in this Interdisciplinary Scientist position. In the following section you are going to answer questions regarding your ability to perform the duties of the Interdisciplinary Scientist.

1. For the GS 12, do you have at least one year of experience at the GS 11 level in the federal government evaluating sameness (physicochemical properties) and bioequivalence of drug formulations; understanding experimental designs and evaluate resulting study data and verify validity of analytical methods; and conveying technical information in clear and concise manner through advanced writing skills?
For the GS 13, do you have at least one year of experience at the GS 12 level you must at least one year of experience at the GS 12 level in the federal government evaluating sameness (physicochemical properties) and bioequivalence of drug formulations; understanding experimental designs and evaluate resulting study data and verify validity of analytical methods; and conveying technical information in clear and concise manner through advanced writing skills; and recommending field investigations be conducted to assure compliance with pertinent Bioresearch Monitoring (BIMO) regulations and verification of the information contained in the application?

A. Yes
B. NO

For each of the following task statements, select one response below (A-E) that best describes your experience level.

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

2. Perform review work including suitability petitions and submissions under generic investigational new animal drug applications (ANADAS), and supplemental ANADAs, (involving evaluation of formulation chemistry, dissolution, in vivo and in vitro study design, clinical endpoint studies, bioequivalence, analytical methods, good laboratory practices (GLP), and (pharmacokinetics) .

3. Determine if new animal drug applications are approvable or submissions are acceptable under existing laws and regulations, whether they are unacceptable.

4. Request additional information, test and data, as necessary to make a decision based on scientific principles, when a submission is not adequate, as well as prepare full approval packages and final action packages resulting from review work.

5. Perform review of labeling and, in many cases, the most currently marketed generic and/or pioneer labeling; and makes certain that the labeling is not misleading or promotional.

6. Participate in the development of bioequivalence guidance documents and other policy documents concerning the necessary information to be submitted in support of an approval.

7. Recommend field investigations be conducted to assure compliance with pertinent Bioresearch Monitoring (BIMO) regulations and verification of the information contained in the application.

8. Serve as a resource in one or more specialized areas (e.g. veterinary medicine, microbiology, pharmacology, chemistry) relating to animal drugs.

9. Prepares comprehensive written, plain language evaluations and conclusions for each section covered during the review of new animal drugs applications.

10. Participate in and, in some cases, lead meetings with sponsors and organizational staff to discuss issues pertaining to microbiological quality of animal drug products.

11. Communicate directly with the sponsor regarding clarification of microbiological procedures and data related to the documents submitted.

12. Participate in and, in some cases, lead development of internal standard operating procedures (SOP) documents.

13. Serve as a contact person and expert in the evaluation of specific science based issues that may come up during an inspection or appear in an Established Inspection Report (EIR).

14. Maintain and develop professional skills by attending scientific meetings, seminars, training course and reading professional journals in which those drugs are discussed and the latest research resulted are presented.

15. Advise supervisor of problems developing within the incumbent's scientific discipline.