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This position is located in the Department of Health and Human Services (DHHS), Office of Medical Products ant Tobacco, Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS), Office of Clinical Pharmacology ,located in Silver Spring, MD.
This vacancy is also being announced concurrently with vacancy announcement FDA-CDER-17-MP-1990451JJ under merit promotion procedures. Please review that announcement to see if you are eligible for consideration under merit promotion procedures.
NOTE: Applicants must apply separately for each announcement in order to be considered.
Who May Apply: Open to all United States Citizens.
Additional selections may be made within the same geographical area FDA-wide.
- Not Required
In order to qualify for Interdisciplinary Scientist, GS-0401/0405/1320-14 you must meet the following:
Basic Requirement Biologist, GS-0401
Possess a bachelor's degree or higher from an accredited college or university in biological sciences, agriculture, natural resource management, chemistry, or a related disciplines appropriate to the position. (You must submit transcript at time of application submission)
Possess a combination of education and experience coursework equivalent to a major in microbiology, biology, chemistry, or basic medical science that included courses as shown in A above plus additional education or appropriate experience. (You must submit transcript at time of application submission)
GS- Pharmacologist, 0405
Have successfully completed a full four-year of study at an accredited college or university leading to a bachelor's or higher 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.
GS- Chemist, 1320
Have successfully completed a full four-year of study at an accredited college or university leading to a bachelor's or higher degree in in physical sciences, life science, or engineering that include 30 semester hours in chemistry, supplemented by course work in mathematics through differential and integral calculus, and at least 6 semester hours of physics.
Have a combination of education and experience--Course work equivalent to a major as shown in above, including the last 30 semester hours in chemistry, supplemented by mathematics through differential and integral calculus, and at least 6 semester hours physics, plus appropriate experience or additional education.
Minimum Qualifications GS-0401/0405/1320-14
Have one year of specialized experience, equivalent to the GS-13 In the Federal service, to include analyzing study designs, of clinical pharmacology or biopharmaceutics submissions associated with Investigational New Drugs (INDS) and New Drug Applications (NDAs); and negotiating with internal/external contact for acceptance of regulatory recommendations and requirements.
Documenting experience: In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above.
If you are claiming education as any part of your qualifications for this position, you must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program. For further information, click on foreign education.
Conditions of Employment:
1. Security and Background Requirements: Appointment will be subject to the applicant's successful completion of a background security investigation and favorable adjudication. Failure to successfully meet these requirements may be grounds for appropriate personnel action. If hired, a background security reinvestigation or supplemental investigation may be required at a later time. Applicants are also advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-consideration, non-selection and/or disciplinary action.
2. E-Verify: If you are selected for this position, the documentation you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the E-Verify System. Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system. The U.S. Department of Health and Human Services is an E-Verify Participant.
3. Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.
4. Pre-employment physical required: No
5. Drug testing required: No
6. License required: No
7. Mobility agreement required: No
8. Immunization required: No
9. A background investigation may be required.
10. Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.
11. Bargaining Unit Position: Yes
12. Financial disclosure statement required: Yes
Q - Nonsensitive
The incumbent will serves as an senior reviewer, provide scientific expertise as a member of multi-disciplinary scientific and medical team engaged in review, evaluating, and decision-making regarding approvability of submission and application requesting FDA regulatory consideration of clinical research, testing and manufacture of human drugs and any other related regulatory submissions
- Assure uniformity and consistency in the policies and procedures governing Clinical Pharmacology and Biopharmaceutics review.
- Stay abreast of complex, long-range and emerging problems of drug safety, efficacy and dosing as well as conflicts in the therapeutic area as applied to the products being regulated.
- Serve as a member of task forces and study group assembled by the Division, Office or Center to consider general problems or specific solution or issues surrounding various drug products.
- Discuss scientific, clinical and regulatory matters arising form submissions under review.