Interdisciplinary Scientist, GS-405/601/660/1320-14


Vacancy ID: 854943   Announcement Number: HHS-FDA-CDER-MP-13-854943   USAJOBS Control Number: 339462000

Occupational/Assessment Questions:

1. Please select the response below that best indicates how you meet the basic education requirement for the Pharmacologist, GS-0405 position.

A. I possess a degree in an appropriate biological, medical, veterinary, or physical science, or in pharmacy that included at least 30 semester hours in chemistry and physiology and 12 semester hours in pharmacology. (Courses in chemistry, organic chemistry, biochemistry, general physiology, and animal, human, microbial, or cellular physiology may be used to meet the 30-semester hour requirement in chemistry and physiology. Courses in pharmacology, pharmacodynamics, pharmacotherapeutic, molecular pharmacology, and other similar subjects may be used to meet the 12-semester hour requirement in pharmacology. Courses dealing intensively with pharmacologically-oriented subjects may also be used to meet this requirement.) Transcript(s) must be submitted with application package prior to the close date of the announcement.
B. I do not possess the education as described above.

2. Please select the response below that best indicates how you meet the basic education requirement for the General Health Scientist, GS-0601 position.

A. I possess a four-year bachelor's degree related to the health sciences or allied sciences appropriate to the work of the position. Transcript(s) must be submitted with application package prior to the close date of the announcement.
B. I do not possess the education as described above.

3. Please select the response below that best indicates how you meet the basic education requirement for the Pharmacist, GS-0660 position.

A. I possess a four-year bachelor's degree in pharmacy from a program recognized by the American Council on Pharmaceutical Education AND possession of a license to practice Pharmacy in a State, territory of the United States, or the District of Columbia. You must provide a copy of your license and reference the details of your license in your resume. Transcript(s) must be submitted with application package prior to the closing date of the announcement.
B. I do not possess the education and experience described above.

4. Please select the response below that best indicates how you meet the basic education requirement for the Chemist, GS-1320 position.

A. I have successfully completed of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in the 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. Transcript(s) must be submitted with application package prior to the close date of the announcement.
B. I possess a combination of education and experience. This includes 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. Transcript(s) must be submitted with application package prior to the close date of the announcement.
C. I do not possess the education and/or experience described above.

5. Please select the response below that reflects your experience in relation to the minimum qualifications for this position.

A. I possess one year of specialized experience, equivalent to at least the GS-13 level in the Federal service, reviewing scientific data of regulatory submissions and applications, including Investigational New Drug Applications (INDAs) and New Drug Applications (NDAs); evaluating clinical pharmacology and biopharmaceutic reviews to develop and implement policies and procedures; and designing pharmacokinetic and pharmacodynamics studies.
(This experience must be clearly supported by your resume)
B. My experience is not reflected in the statement 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. Research issues affecting drug safety, efficacy and dosing to brief industry contacts of the therapeutic area on the products being regulated.

7. Evaluate New Drug Application briefings conducted by a team to recommend actions aimed to enhance quality and credibility.

8. Provide technical guidance on Investigational New Drug (IND) and New Drug Application (NDA) review processes.

9. Design studies to identify and resolve issues affecting a drug review process.

10. Provide technical guidance to clinical pharmacology reviewers in the therapeutic area responsible for issues related to clinical pharmacology and biopharmaceutics reviews.

11. Monitor pharmacological reviews to ensure accordance to Good Review Management Principles (GRMP) timelines.

12. Review policies and procedures governing clinical pharmacology and biopharmaceutic reviews for uniformity and consistency.

Review the Pharmacokinetic and Pharmacodynamic studies and select one response for each that describes your experience, education, or training related to the study.

13. Design and analyze single or multiple-dose studies.

14. Design and analyze mass balance studies.

15. Design and analyze food-effect, bioequivalence, drug-drug interaction, hepatic or renal impairment studies.

16. Design and analyze QT prolongation studies.

17. Design and analyze in vitro an in vivo human metabolism and transporter studies.