Regulatory Policy Analyst

Employer
USAJobs
Location
Silver Spring, Maryland
Posted
Feb 20, 2021
Closes
Feb 27, 2021
Function
Analyst
Hours
Full Time
Duties

Summary

This position is located in the Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Office of Regulatory Policy (ORP), Divisions of Regulatory Policy (DRPs), Immediate Office (IO), located in Silver Spring, Maryland.
Learn more about this agency

Responsibilities

  • Develops policies and programs and reviews regulations and policy statements involving complex matters affecting the regulation of drug products.
  • Performs duties that include resolving a broad range of issues concerning the application of FDA's enabling legislation, pertinent regulations, and/or general legislation affecting the operation of the Federal Government.
  • Develop written products that articulate, interpret, and explain complex programs and public health research findings to various audiences.
  • Coordinate, contribute to, or manage projects to revise or develop FDA laws, regulations, guidance documents, policies and procedures.
  • Provide guidance and/or training to regulatory specialists and other professionals within FDA on matters relating to his/her expertise.
  • Conduct analysis of regulatory and policy issues and provide advice to staff in carrying out ORP/CDER 's regulatory mission.
  • Represents the Office?s program areas and issues in meetings to others, such as Office and Center Directors and various professional organizations.


Travel Required

25% or less - You may be expected to travel for this position.

Supervisory status
No

Promotion Potential
None

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 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.
  • Applicants must have at least a fully successful or equivalent performance rating to receive further consideration for this position.
  • 25% temporary duty travel required.


Qualifications

The position of Regulatory Policy Analyst falls within the 0301 occupational series. To qualify for this position at grade GS-14, you must meet Time-in-Grade requirements by 11:59 pm EST on 02/26/2021.

MINIMUM QUALIFICATIONS: Specialized experience is defined as experience that is typically in or related to the work of the position to be filled and has equipped the applicant with the particular knowledge, skills, and abilities to successfully perform the duties of the position.

To qualify for the GS-14:
You must demonstrate in your resume at least one (1) year of qualifying experience equivalent to the GS-13 in the Federal Service that includes developing and implementing organizational policies or programs related to FDA regulated products; Serving as an advisor on legal or regulatory issues AND Analyzing and interpreting scientific and regulatory data; identifying problems and suggesting a corrective course of action.


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.

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. 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 details.
Be sure that any files you upload as supporting documentation are free of security or compression features which render such documents unreadable to our system.

Education

There is no education substitution for this position or GS-14 grade level.

Additional information

ADDITIONAL CONDITIONS OF EMPLOYMENT:

We may make additional 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. By applying, you agree to have your application shared with any interested selecting official(s) at HHS. There is no option to opt-out as your information will not be shared 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: Yes, 3591
  • If you are serving, or have served in the last 5 years (from 02/26/2021) 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
  • Financial disclosure statement, OGE-450, required: NO
All requirements must be met by the closing date of this announcement (02/26/2021); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the hiring process.
Additional 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.

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 02/26/2021), 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.

Volunteer experience can also be used as qualifying experience.

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.
  • Organizational Awareness
  • Policy, Planning and Management
  • Oral Communications
  • Written Communication
  • To preview the application questionnaire, click the link below.
    https://apply.usastaffing.gov/ViewQuestionnaire/11029228


    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
    Suitability/Fitness

    Required Documents

    REQUIRED DOCUMENTS:
    • Resume
    • SF-50/ Notification of Personnel Action

    Resume Requirements:
    • Resume Writing Tutorial
    • Resume Writing FAQ
    ACCEPTED DOCUMENTS:
    • Cover Letter
    • DD-214/ Statement of Service
    • Disability Letter (Schedule A)
    • Disability Letter (VA)
    • License
    • Other supporting documentation not listed above
    • PCS Orders
    • Performance Appraisal
    • Professional Certification
    • Resume
    • Separation Notice (RIF)
    • SF-15
    • SF-50/ Notification of Personnel Action
    • Transcript

    *Accepted documents may be required for some applicants depending on which eligibility options you're applying 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 and Former Federal Employees:
    PLEASE NOTE: To properly verify status eligibility and time-in-grade, you must submit the following:
      SF-50: from your most recent Promotion, or your last grade/step increase -Within Rate/Grade Increase (WRI/WGI), showing you are/were in the competitive service and the highest grade or promotion potential held, and ensure that your competitive status, tenure, SCD, and highest grade held are shown. If you do not submit an appropriate SF-50, we cannot verify your status eligibility or Time-in-Grade. You may submit multiple SF-50's.. SF-50 submitted cannot be an annual pay adjustment or award.
      Your SF-50 must show the following information:
  • Full position title;
  • Appointment type;
  • Pay Plan, Series, Grade & Step;
  • Tenure code; and
  • Service Computation Date (SCD).

  • Please ensure your SF-50 includes the information above or your eligibility and Time-in-Grade cannot be verified.

    Learn more on the USAJOBS SF-50 Help Page .

    Your performance appraisal is not required at the time that you submit your application. If you receive an interview and your performance appraisal is requested, you should submit your most recent performance year on file, and it should show the signature and rating. People 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 FDA employees:
    If you are a former Department of Health and Human Services 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. See the How You Will Be Evaluated section for the agency's definition of well-qualified. Learn more on the USAJOBS Career Transition Assistance Site .

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