To qualify at the grade GS-12: Applicants must have at least one full year of specialized experience comparable in scope and responsibility to at least the GS-11 level in the Federal service (this experience can be obtained in either the public or private sectors). Examples of specialized experience include, providing information on a variety of topics associated with the regulatory review process and user fee requirements as it relates to internet initiatives. Providing quality assurance pertaining to the integrity and accuracy of existing and new scientific and regulatory information added to a web based system using web coding such as HTML and Dreamweaver. Reviewing web content information and identify contradictions relating to 508 compliance. Delivering training to a variety of end- users using acceptable methods and techniques.
To qualify at the grade GS-13: Applicants must have at least one full year of specialized experience comparable in scope and responsibility to at least the GS-12 level in the Federal service (this experience can be obtained in either the public or private sectors). Examples of specialized experience include, providing expert advice on a variety of topics associated with the regulatory review process and user fee requirements as it relates to internet initiatives. Providing guidance and assistance to others on complex requests regarding quality assurance pertaining to the integrity and accuracy of existing and new scientific and regulatory information added to a web based system using web coding such as HTML and Dreamweaver. Reviewing web content information and identify contradictions relating to 508 compliance. Delivering training to a variety of end-users using acceptable methods and techniques.
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.
Applicants must have met the qualification requirements (including selective placement factors - if any) for this position by the closing date OR within 30 calendar days of the closing date to be eligible for this position.
There is no substitution of education for experience for this position.
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: No
8. Bargaining Unit Position: Yes
9. Drug Screening Required:
No 10. Time in grade (TIG) must be met within 30 days of the closing date of the announcement.
HOW YOU WILL BE EVALUATED:
Once the application process is complete, a review of the resume 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 resume and/or supporting documentation, a determination is made that you have inflated your qualifications and/or experience, you may lose consideration for this position. Please follow all instructions carefully. Errors or omissions may affect your eligibility. Merit Promotion Procedures for the Food and Drug Administration (FDA) 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 ranked into one of two categories: Best Qualified or Qualified.
Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics):
- Knowledge of biologics regulatory review process in order to identify information needs and to develop reports.
- Knowledge of legislation and regulations affecting biologics and FDAs review process in order to identify and satisfy information reporting needs.
- Ability to evaluate the effectiveness of internet information system in order to determine the appropriate enhancement and/or improvements to the system.
- Ability to communicate orally in order to conduct training and give presentations on the Centers information system.
Agency Career Transition Assistance Program (CTAP) or the Interagency Career Transition Assistance Program (ICTAP) Eligibles: If you have never worked for the Federal government, you are not CTAP/ICTAP eligible. Information about ICTAP or CTAP eligibility can be found at http://archive.opm.gov/ctap/index.asp to access OPMs Career Transition Resources website. To be considered well qualified under CTAP/ ICTAP, you must be placed in the Well Qualified category for this position (achieving a score of at least 85). In addition, you must submit the supporting documents listed under the required documents section of this announcement.
Veterans: Certain veterans are eligible to apply as a status candidate under the Veterans Employment Opportunity Act (VEOA). Please submit copy 4 of your DD214 to substantiate claim. For more information, please click http://www.fedshirevets.gov/job/shav/index.aspx