Clarification from the agency

Open to Current FDA Employees Only Current permanent employees of the Food and Drug Administration may apply if serving on a career or career conditional appointment. PHS Commissioned Corps Officers interested in performing duties of this position as a Commissioned Officer may apply for consideration. Candidates will be referred to the Selecting Official for consideration on a Commissioned Corps assignment but not as candidates for a career-conditional/career appointment under Title 5.

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• The incumbent serves as a Branch Chief for the Division of Regulatory Science Informatics (DRSI), working under the general supervision of the Deputy Director, DRSI.
• Provides supervision and direction to professional and administrative staff as may be determined necessary to establish and foster development of an excellent, customer focused regulatory science informatics program.
• Serves as science and health informatics expert and provides leadership within the Office concerning technology for scientific data analysis and management, and data quality, in areas of research, product review, and public health.
• Develops and directs the development and implementation of polices and standard operating procedures for business information management activities to facilitate consistency across the organization.
• Provides authoritative advice, leadership, supervision, and direction to a staff responsible for managing Office-led projects to ensure data quality for the regulatory health information systems met the organization mission.

Conditions of employment

• Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.
• FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
• Selective Service Registration: All applicants born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption. Visit www.SSS.gov for more info.
• Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
• Time-in-Grade Requirement: If you are applying as a current Federal employee, you must meet the time-in-grade requirements described in the Qualifications section, generally, 52-weeks of comparable experience at the next lowest grade.
• Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
• You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and qualifications attained by this date will be considered. You must continue to meet all requirements through the hiring process.
• Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
• Additional selections may be made from this vacancy, within the same geographical area, by other organizational elements from within FDA, through shared corporate recruiting activities.
• You may be required to serve a one-year supervisory/managerial probationary period (if requirements has not previously been satisfied).

Qualifications

The position of Supervisory Regulatory Health Information Specialist falls within the 0601 occupational series. To qualify for this position at grade GS-15, you must meet Time-in-Grade requirements by 11:59 pm EST on 05/02/2022.

Time-in-Grade: Any individual who is currently holding, or has held within the previous 52 weeks, a General Schedule position under non-temporary appointment in the competitive or excepted service, must meet time-in-grade requirements (must have served 52 weeks at the next lower grade or equivalent in the Federal service). Time-in-grade requirements must be met by the closing date of this announcement.

Basic Qualification Requirement

Education:

Bachelor's or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education (external link) at the time the degree was obtained.

NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.

AND

Minimum Qualifications

For the GS-15: Applicants must have one (1) year of specialized experience, equivalent to at least the GS-14 grade level in the Federal Service which includes, planning and leading scientific and regulatory program information systems and processes, that support the scientific and public health goals for a program; designing, implementing and providing recommendations on regulatory science research processes and assessing public health risk associated with a scientific program.

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.

PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.

NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date. To verify your application is complete, log into your USAJOBS account, https://my.usajobs.gov/Account/Login, select the Application Status link and then select the More Information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process.

IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of experience. In addition to describing duties performed, applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information, failure to provide this information may result in disqualification. Applicants are encouraged to use the USAJOBS Resume Builder to develop their federal resume.

Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community, student, social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.

You must submit supporting documentation to verify your eligibility to apply for this vacancy.
For internal applicants an SF-50 will be required. If Educational requirements are listed, you must submit a Transcript, even if you occupy the series/grade in question. See the Required Documents section for full details...

How you will be evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

Additional selections may be made for similar positions across the Department of Health and Human Services (HHS) within the local commuting area(s) of the location identified in this announcement. By applying, you agree to have your application shared with interested selecting official(s) at HHS. Clearance of CTAP/ICTAP will be applied for similar positions across HHS.

Once the job opportunity announcement closes (at 11:59 pm Eastern Time on 05/02/2022), a review of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for this internal position. Eligible internal candidates will be referred to the hiring official for consideration.

If you are referred to the hiring manager for consideration, you may be further evaluated based on an interview; review of requested work samples, writing samples, most recent performance evaluation(s), or professional references; or results of an oral presentation or work-related test. Failure to comply with any of the additional assessment requirements will result in removal from further consideration. These assessment methods/tools may also be listed under Key Requirements.

Please follow all instructions carefully. Errors or omissions may affect your eligibility.

Basis of Rating: Merit Promotion Procedures for the Food and Drug Administration (FDA) 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 three categories: Best Qualified, Well-Qualified or Qualified.

Career Transition Assistance Program (CTAP): Well-Qualified is defined as an applicant who meets the qualification standards and eligibility requirements for the position, including minimum educational and experience requirements; any medical qualifications and suitability; is able to perform the essential duties of the position, with or without reasonable accommodation; meets any applicable selective placement factors) for the position (such as the ability to speak a specific language or any other factor required immediately upon hire); and is able to satisfactorily perform the duties of the position upon entry. To be well-qualified and exercise selection priority for this vacancy, surplus or displaced Federal employees must be rated at 85.0 or above on the rating criteria for this position. Learn more on the USAJOBS Career Transition Assistance Site.

Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You do not have to respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of the Competencies/KSA's.

1. Leadership
2. Information Management
3. Strategic Thinking
4. Oral Communication