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Biologist

Company: US Department of Health and Human Services
Location: Silver Spring
Posted on: December 5, 2019

Job Description:

Skills - FDA Regulations Benefits - Health Insurance Duties Summary This position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Office of the Commissioner (OC), Office of Clinical Policy and Programs (OCPP), Office of Combination Products (OCP) located in Silver Spring, MD. Responsibilities Ensures the regulations and policies developed in the assigned areas are consistent with statutory requirements and existing policy and that their need is justified. Serves as a member of inter-agency task forces and study groups tasked to identify problems, recommend solutions or provide direction in the area of study. Resolves a broad range of issues concerning the application of any of FDA?s enabling legislation, pertinent regulations, and/or general legislation affecting the operation of the Federal government. Prepares replies to correspondence from the regulated community and other interested persons on issues that are industry wide in scope or have broad health implications and that concern precedent setting interpretations of FDA policy. Provides consultation and expert advice on scientific and policy issues in the area of study to various agencies, foreign governments, international organizations, and FDA. Travel Required 25% or less - You may be expected to travel for this position. Supervisory status No Promotion Potential 14 Job family (Series) 0401 General Natural Resources Management And Biological Sciences Requirements Requirements 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 *********** 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 itional investigations at a later time. Time-in-Grade Requirement: If you areing 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. itional selections may be made from this vacancy, within the same geographical area, by other organizational elements from within FDA, through d corporate recruiting activities. Qualifications The position of Biologist falls within the 0401 occupational series. To qualify for this position at grade GS-14, you must meet Time-in-Grade requirements by 11:59 pm EST on 11/25/2019. In ition to meeting Time-in-Grade requirements above, you must also meet the following Basic Education Requirement AND Specialized Experience Requirement below: Basic Education: Have a degree in biological sciences, biology, engineering, chemistry, or related disciplines appropriate to the position; OR Have a combination of education and experience: Courses equivalent to a major, as shown above, plus appropriate experience or itional education. AND Specialized Experience: Have one year of specialized experience, equivalent to the GS-13 grade level in the Federal service, developing and implementing scientific regulatory policies that affect the regulation of combination products (i.e., therapeutic and diagnostic products that combine a drug, device, and/or biological product); researching controversial scientific-regulatory issues, analyzing and recommending solutions and/or corrective actions. 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 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, ************************************* 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 ition 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. You must submit supporting documentation to verify your eligibility to 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 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 more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation. SUBMITTING YOUR TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. A transcript is required to verify educational achievement. Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements. Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access. See the Application Manager Documentation for tips on submitting your paper-based documents. itional information ITIONAL CONDITIONS OF EMPLOYMENT: We may make itional selections for similar positions across the entire Department of Health and Human Services (HHS) within the local commuting area(s) identified in this vacancy announcement. Bying, you agree to have your application d with any interested selecting official(s) at HHS. There is no option to opt-out as your information will not be d with other hiring agencies outside of HHS. Pre-employment physical required: No Drug testing required: No License required: No Mobility agreement required: No Immunization required: No Bargaining Unit Position: No If you are serving, or have served in the last 5 years (from 11/25/2019) 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 ition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. Political Appointees FAQ - OPM All requirements must be met by the closing date of this announcement (11/25/2019); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the hiring process. itional selections may be made within the same geographical area FDA-wide. 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 Eastern Time on 11/25/2019), 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 this internal position. Eligible internal candidates will be referred to the hiring official for consideration. 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 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. Technical Competence (Policy Development/Analysis) Research Problem Solving Writing Oral Communication To preview the application questionnaire, click the link below. ******************************************************** Background checks and security clearance Security clearance Not Required Drug test required No Position sensitivity and risk Non-sensitive (NS)/Low Risk Trust determination process Credentialing Required Documents Required Documents REQUIRED DOCUMENTS: Resume Transcript Resume Requirements: Resume Writing Tutorial Resume Writing FAQ ACCEPTED DOCUMENTS: Cover Letter Disability Letter (Schedule A) PHS Commissioned Corps Document Performance Appraisal Professional Certification Resume SF-50/ Notification of Personnel Action Transcript - Accepted documents may be required for some applicants depending on which eligibility options you'reing for, see the list below for details for each eligibility. If you need help submitting documentation, please see Applicant Help Site - Documents. If you are still unsure what documents might be required of you, please contact the FDA Applicant Help Desk before the announcement closes. For transcript submission requirements, see the Education section. Current & Former Federal Employees:You will need to submit the following: a copy of your most recent SF-50 (Standard Form 50 - Notice of Personnel Action) to verify your eligibility status a copy of your most recent performance appraisal showing your final rating for the recent performance year Your SF-50 must show the following information: 1) Full position title; 2) Appointment type; 3) Pay Plan, Series, Grade & Step; 4) Tenure code; and 5) Service Computation Date (SCD). If your last SF-50 is from a pay adjustment, check that it has all the items above. If not, also include your most recent SF-50 from a promotion, reassignment, or other non-pay action. Learn more on the USAJOBS SF-50 Help Page. Your performance appraisal should be from the most recent full performance year on file, and should show the signature and rating. Schedule A: Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities, may 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. CTAP: If you are a former HHS 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 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 Benefits 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.

Keywords: US Department of Health and Human Services, Silver Spring , Biologist, Other , Silver Spring, Maryland

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