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Regulatory Information Specialist

Company: Food and Drug Administration
Location: Silver Spring
Posted on: March 11, 2019

Job Description:

- Duties HelpDuties Summary This position is located in the Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA), Department of Health and Human Services (HHS). The purpose of this position is to assist in managing a computer based regulatory information system covering the products regulated by the division. Learn more about this agency Responsibilities - Compile computerized regulatory information/data pertaining to assigned products regulated by the division - Assist higher-level specialists in managing assigned areas of the regulatory information system that supports products submissions and licenses regulated by the Division. - Assist in coordinating and/or providing both periodic and special reports pertaining to product review status activities for product submissions. - Assist higher level specialists in identifying where information for the assigned areas may impact other data found in multiple parts of the assigned database systems and how those data need to interact. Travel Required 25% or less - You may be expected to travel for this position. Supervisory status No Promotion Potential 11 - #### Job family (Series) 0301 Miscellaneous Administration And Program - Requirements HelpRequirements Conditions of Employment - Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise. - 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 *********** for more info. - 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. - 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. - 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. - 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. - 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 under the*0301occupational series. To qualify for this position at gradeGS-*9, you must meet Time-in-Grade requirements by 11:59 pm EST on 03/17/2019. In order to qualify for the Regulatory Information Specialist, GS-0301-9, you must meet the following requirements: Have at least one year of specialized experience, equivalent to the GS-7 grade level in the Federal service, which include experience, gathering information derived from web based systems and electronic spreadsheets; provide communications to stakeholders as indicated in regulatory reviews or management; plan and carry out projects to improve administrative support efficiency/productivity; gather data and analyze trends to enhance work performance; generate reports and make recommendations to managers related to internal regulator operations. - OR- Have 2 years of progressively higher level graduate education leading to a master's degree or master's or equivalent graduate degree. - OR- Have a combination of the required experience and education for this grade.** 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. If you are applying based on some other qualifying eligibility (i.e. you are not applying as a current Federal employee), you must meet the specific requirements of the eligibility you are claiming, and must have sufficient past experience to demonstrate that you are minimally qualified for this position. See Unique Hiring Paths on USAJOBS for more information about various ways you may be eligible to apply! 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. You must submit supporting documentation to verify your eligibility to apply for this vacancy. For most applicants, an SF-50 will be required. However, if you are applying as a Veteran, individual with a qualifying disability, or a displaced employee, you will be required to provide other supporting documents as applicable. See the Required Documents section for more details. Education Foreign Education: If you are using education completed at 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. If you have transferred educational credit from a foreign institution to one in the U.S., you must still show that your foreign education was evaluated by an organization recognized by the Department of Education, even if that foreign education was accepted as transfer credit by a domestic college or university. For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation. Additional information For some advertisements, the Food & Drug Administration receives hundreds, even thousands, of applications from job-seekers. Because of this high level of interest in positions with the FDA, the agency reserves the option of setting an application number limit. When an application limit is set, USAJOBS will close the vacancy at 11:59 pm Eastern Time on either: (A) the day the limit is reached, -OR- (B) the pre-defined closing date of 03/17/2019, whichever comes first. If the limit is reached before 11:59 pm ET, all applications in excess of the limit will continue to be accepted until 11:59 pm ET. The application limit for this advertisement, if applicable, is: No limit. For more information about announcement closing, see: ************************************************************* ADDITIONAL CONDITIONS OF EMPLOYMENT: - Pre-employment physical required: No - Drug testing required: No - License required: No - Mobility agreement required: No - Immunization required: No - Bargaining Unit Position: Yes - Incentives may be authorized; however, this is contingent upon funds availability.If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc. - If you are serving, or have served in the last 5 years (from 03/17/2019) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. Political Appointees FAQ - OPM - Veterans Preference: If you plan to apply based on Veterans Preference, please pay careful attention to the 'Required Documents' section for more information about what to provide in your application. USAJOBS Veterans Site. - Schedule A: If you plan to apply under Schedule A based on a disability, please pay careful attention to the 'Required Documents' section for more information about what to provide in your application. USAJOBS Individuals with Disabilities Site. - Career Transition Programs: If you are a displaced Federal employee and plan to apply under CTAP or ICTAP, please pay careful attention to the 'Required Documents' section for more information about what to provide in your application. USAJOBS Career Transtion SIte. All requirements must be met by the closing date of this announcement (03/17/2019); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process. Read more How You Will Be Evaluated You will be evaluated for this job based on how well you meet the qualifications above. Once the job opportunity announcement closes (at 11:59 pm ET on 03/17/2019), 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 Federal employment, and then whether you are qualified for this particular position. If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible, or your score may be adjusted to more accurately reflect your skills and abilities. Additionally, we will review your supporting documents and resume to determine if you are in the 'Area of Consideration' for this vacancy. Government-Wide Merit Promotion vacancies may only accept applications from a limited audience, pay careful attention to the 'Who May Apply' and the 'Hiring Paths' information. 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 two categories: Best Qualified or Qualified. Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You need not respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of these competencies. - Data Management. - Database System Information. - Written Communication. - Oral Communication. To preview the application questionnaire, click the link below. ******************************************************** Read more Background checks and security clearance Security clearance Other Drug test required No - Required Documents HelpRequired Documents The following documents will be required for ALL applicants: * Resume These documents are necessary to determine your eligibility and/or qualification for this vacancy. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application. If you need instructions or assistance with submitting documentation, please see the Applicant Help Site - Documents page for more information. OTHER ELIGIBILITY-SUPPORTING DOCUMENT REQUIREMENTS: Current and former Federal employees:You will need to submit a copy of your most recent SF-50 (Standard Form 50 - Notice of Personnel Action). To properly verify status eligibility, your SF-50 must show the following information. (If you do not submit an appropriate SF-50, we cannot verify your status eligibility!) - Full position title; - Appointment type; - Occupational series; - Pay plan, series, grade, and step; - Tenure code; and - Service Computation Date (SCD). If your most recent SF-50 is from an annual pay adjustment, please ensure it contains the information listed above. If it does not, then you should also include your most recent SF-50 that does show your last promotion, execution of appointment, or grade / step increase, and ensure that your competitive status, tenure, SCD, and highest grade held are shown. Learn more about the SF-50 on the USAJOBS SF-50 Help Page. Applicants claiming Veterans Preference:Must submit a copy of your DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status. * Active Duty Members:To claim status Under the VOW (Veterans Opportunity to Work) to hire Heroes Act of 2011, submit written documentation from the armed forces that certifies the service member is expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the certification is submitted with your application package. * Parents of Deceased or Disabled Veterans: To claim status under Gold Star Fathers Act of 2015, you must submit a copy of the deceased or disabled veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference. Please follow the instructions in the SF-15 on required documentation to be submitted. * Widow or Widower: To claim preference, you must submit a copy of the deceased or disabled veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference. Please follow the instructions in the SF-15 on required documentation to be submitted. * Spouse of a Living Veteran:To claim preference, you must submit a copy of the veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference, and Documentation of Veteran's Inability to Work Because of a Service-Connected Disability. Please follow the instructions in the SF-15 on required documentation to be submitted. * See the Feds Hire Vets site for detailed information about documentation requirements. * USAJOBS also maintains a help page for Veterans. Individuals with Disabilities (Schedule A): Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities, may apply for appointment through the Schedule A hiring authority. Certified verification of a disability from a licensed medical professional; a licensed vocational rehabilitation specialist; or any Federal, state, or District of Columbia agency or U.S. territory that issues or provides disability benefits will be required. Learn more on the USAJOBS Individuals with Disabilities Site. Displaced Federal employees who qualify for CTAP/ICTAP: If you are a former Federal employee who was displaced due to a Reduction-in-Force (RIF) or surplused by some other means, please submit a copy of the separation letter or RIF notice from your agency. To be selected under I/CTAP, you must still be found well-qualified for this position. Learn more on the USAJOBS Career Transition Assistance Site. If you are relying on your education to meet qualification requirements: Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education. Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating. - Benefits HelpBenefits A career with the U.S. Government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Learn more about federal benefits. Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time, or intermittent. Contact the hiring agency for more information on the specific benefits offered. - How to Apply HelpHow to Apply To apply for positions with the Food & Drug Administration, you must have a USAJOBS ********* account, and be signed in to that account, before you click 'Apply Online'. See the USAJOBS Help Site article 'How does the application process work?' for more on this process. Additionally, you must provide a resume and any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement, 03/17/2019 We recommend that you start the application process early enough that you can complete and submit your application before this deadline. Please note that you cannot submit documentation or make changes to your application after the close date. If you would like to learn how to use USAJOBS including: accessing and managing your account, adding saved documents, building a resume, or starting an application; we recommend you visit the USAJOBS How To site, and read up on any topic that you need help with. This site is located at: ************************************* Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Help site at: ****************************** FDA's Applicant Help Desk is not able to support USAJOBS-related issues. The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are not familiar with Application Manager or encounter any difficulty with the site, we recommend that you review the Applicant HELP Site at: ************************************************************* This help site contains step-by-step instructions for completing the application process, submitting documentation, and completing questionnaires, and should be very helpful to you! You are encouraged to apply online. Applying online will allow you to review and track the status of your application. The FDA will provide reasonable accommodation to applicants with disabilities who are not able to apply online. If you need a reasonable accommodation for any part of the application process, please contact the Applicant Help Desk. Decisions on granting a reasonable accommodation will be made on a case-by-case basis. If after reviewing the USAJOBS and Application Manager help sites, you're not able to find the answer to your question or concern, or if you wish to request a reasonable accommodation, please contact the FDA Applicant Help Desk at ************, or e-mail **********************. The Applicant Help Desk is staffed between the hours of 7am and 6pm Eastern Time, Monday through Friday, except for government holidays. If you contact the Applicant Help Desk, please provide the following Vacancy Identification Number (VIN) ******** so that we may assist you faster. Read more Agency contact information FDA Applicant Help Desk Phone ************ Email ********************** Address Center for Biologics Evaluation and Research 10903 New Hampshire Ave Silver Spring, MD 20993 US Learn more about this agency Next steps Once your application is submitted you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We strive to make selections within 45 days of the closing date of this announcement. You will receive application status updates by email and on USAJOBS as the process unfolds. How to check your application status viaUSAJOBS and understand what each status means. How does the Hiring Process Work? Read more - Fair & Transparent Fair & Transparent The Federal hiring process is setup to be fair and transparent. Please read the following guidance. Equal Employment Opportunity Policy The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor. - Equal Employment Opportunity (EEO) for federal employees & job applicants Read more Reasonable Accommodation Policy Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis. A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits. Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when: - An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job. - An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace. - An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events. You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis. Learn more about disability employment and reasonable accommodations or how to contact an agency. Read more Legal and regulatory guidance - Financial suitability - Social security number request - Privacy Act - Signature and false statements - Selective Service - New employee probationary period This job originated on ***************. For the full announcement and to apply, visit ********************************************* Only resumes submitted according to the instructions on the job announcement listed at *************** will be considered. Open & closing dates: 03/06/2019 to 03/17/2019 Service: Competitive Pay scale & grade: GS 9 Salary: $56,233 to $73,105 per year Appointment type: Permanent Work schedule: Full-Time

Keywords: Food and Drug Administration, Silver Spring , Regulatory Information Specialist, Other , Silver Spring, Maryland

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