The position is located in the Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Office of Vaccines Research and Review (OVRR), Division of Vaccines and Related Product Applications (DVRPA), Review Management Support Branch (RMSB). OVRR and DVRPA protect and enhance the public health by ensuring the availability of safe and effective vaccines, allergic extracts, and related products.

Duties

Maintains quality assurance activities pertaining to the integrity and accuracy of information already in the systems, enters new data and corrects errors in the systems. Maintains the overall integrity and accuracy of information and data in the CBER regulatory information systems and has a comprehensive in-depth knowledge of the types of information contained in those systems. Assures the data entry staff understands why and how specific information is placed into the system, and the importance of achieving accuracy in all data input operations. Works with CBER reviewers to create an understanding and appreciation of why information systems exist, what information can be found in the systems, and how that information (data) can be used. Verifies industry compliance with Agency labeling requirements and prepares regulatory correspondence for INDs, Master Files (MF), and BLAs and other written regulatory correspondence. Works with regulatory review staff and managers in the preparation, drafting, and issuance of regulatory correspondence for INDs, MFs’ BLAs, labeling, and other written regulatory communications. Works with senior level staff in identifying the need for modifications to current information or the addition of new information and recommendations for the creation of new modules.

Requirements

• 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.

Qualifications

The position of Regulatory Information Specialist falls within the 0301 occupational series. To qualify for this position at grade GS-12, you must meet Time-in-Grade requirements by 11:59 pm EST on 02/16/2024. Minimum Qualifications: Specialized experience is experience that equipped the applicant 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. The specialized experience must demonstrate one year of full-time work experience, or the equivalent if part-time (for example, an employee working 20 hours per week for a 12-month period should be credited with 6 months of experience.) Experience may have been obtained in either the federal service or its equivalent with state or local government, the private sector, or nongovernmental organizations. Specialized Experience for GS-12: You must have at least one (1) year of specialized experience that is equivalent to at least the GS-11 grade level in the Federal service, which includes: (1) receipt and processing of incoming regulatory submissions to the Office; AND (2) providing quality assurance pertaining to the overall integrity and accuracy of information and data entered and maintained in the systems; AND (3) providing communications to stakeholders as indicated in regulatory reviews. 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...

Education

There is no educational substitution for this grade level.

Contacts

• Address FDA Center for Biologics Evaluation and Research 10903 New Hampshire Ave Silver Spring, MD 20993 US
• Name: FDA Applicant Help Desk
• Phone: 866-807-3742
• Email: [email protected]