In order to qualify for this position you must meet both the Basic Requirement and Specialized Experience specified below.
Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree that included a major field of study in an academic field related to health sciences or allied sciences appropriate to the work of this position.
GS-12: At least one full year of specialized experience, equivalent to the difficulty and complexity at the GS-11 or higher grade level in the Federal Service, advising on regulations and administrative procedures related to a biologic product approval process; identifying and resolving resource needs or conflicts, availability and scheduling of a regulatory health project; providing up-to-date status of project progress; and, managing and coordinating the review activities of a team.
GS-13: At least one full year of specialized experience, equivalent to the difficulty and complexity at the GS-12 or higher grade level in the Federal service, analyzing biologic review processes and designing internal controls for regulatory health projects; providing technical guidance to a review team on the FDA regulations, legislation, and administrative procedures involved in the biologic product approval process; managing and coordinating the review activities of a team; negotiating and resolving issues affecting the management of drug review applications; and performing the full range of project management duties related to the biologic product approval process.
This position requires that specific course(s) be demonstrated to meet the basic education requirement. Your transcript(s) must clearly demonstrate the course(s) listed in the qualification requirement section. If the transcript(s) does not clearly demonstrate this you must submit a copy of the course description and/or other documentation demonstrating that the courses are equivalent.
Failure to provide any of the above will result in an ineligible rating.
Foreign Education: 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
All qualification requirements must be met by 11:59 PM (Eastern Time) on the closing date of this vacancy announcement.
Conditions of Employment:
1. Security and Background Requirements: If not previously completed, a background security investigation will be required for all appointees. 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. In addition, 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 appropriate disciplinary action.
2. E-Verify: If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "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. All qualification requirements must be met by the closing date of the announcement.
5. Financial disclosure statement may be required.
6. One-year probationary period may be required.
7. Travel, transportation, and relocation expenses will be paid: Maybe
8. Bargaining Unit Position: No
9. Drug Screening Required: No
10. Recruitment incentives may be authorized: No
11. Student loan repayment incentive authorized: No
12. Annual leave for non-federal service authorized: No
HOW YOU WILL BE EVALUATED:
Once the job opportunity announcement closes, a review of your résumé and supporting documentation will be made and compared against your responses to the assessment questionnaire to determine if you are qualified for this job.
If, after reviewing your résumé and supporting documentation, a determination is made that you have inflated your responses when compared to your background information, your score may be adjusted to more accurately reflect your skills and abilities. Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Qualified candidates will be assigned to the following quality categories:
Best Qualified - Meets the minimum qualification requirements and excels in most requirements of the position.
Well Qualified - Meets the minimum qualification requirements and meets most requirements of the position.
Qualified - Meet the minimum qualification requirements, but does not possess the relevant competencies to a substantive degree.
The category assignment is a measure of the degree in which your background matches the required competencies listed below for this position.
- Managing a Review Team
- Project Management
- Oral Communication
- Written Communication
Application of Veterans' Preference: Under Category Rating procedures, veteran preference eligibles will receive selection consideration before non-preference eligibles within each quality category.
To preview the assessment questionnaire, click the following link:View Assessment Questions