You must have one (1) year of specialized experience, equivalent to the next lower grade level that has equipped you with the particular knowledge, skills and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled.
To qualify for this position at the GS-15 grade level, you must have at least one full year of specialized experience equivalent to the GS-14 grade level or equivalent that includes directing or overseeing a subordinate staff performing assignments of a national scope resolving issues concerning scientific matters related to appeals, disputes, requests for review/hearings regarding Food, Drug, Devices, Tobacco or Biologics based regulatory matters, information and decisions. Experience working with scientists, attorneys and/or policymakers in analyzing and developing Food, Drug, Devices, Tobacco or Biologics regulations, policies and procedures for reviewing appeals, requests or disputes and overseeing the resolution of informal disputes.
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; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit: http://www.ed.gov.
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. Travel, transportation, and relocation expenses may be paid, subject to availability of funds: No
7. Bargaining Unit Position: No
8. Drug Screening Required: No
9. Recruitment incentives may be authorized, subject to availability of funds: No
10. Student loan repayment incentive may be authorized, subject to availability of funds: No
11. 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.
Basis of Rating:
Category rating procedures will be used to rate and rank candidates. The category assignment is a measure of the degree in which your background matches the competencies required for this position. Qualified candidates will be assigned to one of the following quality categories: Best Qualified, Well Qualified or Qualified.
Best Qualified Applicants who have experience that is almost identical to those required by the position, including any quality ranking factors identified.
Well Qualified Applicants who have experience that is very similar to those required by the position.
Qualified Applicants who meet minimum qualification requirements, but do not identify any additional qualifying experience or skill.
The Category Rating Process does not add veterans preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 10 percent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher). Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You do not have to respond to the KSAs separately, but your resume should contain sufficient information to demonstrate possession of the KSAs.
Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics).
Required Knowledge, Skills, and Abilities (KSAs):
1. Knowledge of laws, legislation, policies and guidelines related to regulatory programs in Food, Drug, Devices, Tobacco or Biologics and public health relevant to food and drug law and matters concerning protection of human subjects and assurance of research integrity.
2. Ability to research, evaluate and analyze facts and legal information, formulating conclusions.
3. Skill in analyzing and resolving disputes or differences about Food, Drug, Devices, Tobacco or Biologics related and regulatory determinations.
4. Ability to foster cooperative working relationships.
5. Ability to provide oversight, leadership, and technical expertise in the development and implementation and regulatory policy, related to Food, Drug, Devices, Tobacco or Biologics.
6. Skill in written communication.