Food and Drug Administration Regulatory Counsel in Silver Spring, Maryland

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Duties
Summary

This position is located in the Center for Drug Evaluation (CDER), Office of Medical Policy (OMP), Division of Medical Policy Development (DMPD) which develops medical policy pertaining to the drug development, drug approval, bioresearch monitoring, human subject protection and post market surveillance processes; and assist FDA staff and external constituents on implementation or application of new and existing medical policies and procedures.

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Responsibilities
  • Serves as a recognized government-wide expert in regulatory matters related to his or her area of responsibility and is frequently called on to advise others concerning FDA statutes, regulations, and policies.
  • Drafts or reviews new regulations and guidance.
  • Leads or works as a part of established workgroups to develop regulations and guidance, advising on compliance with regulatory and scientific issues.
  • Prepares replies to correspondence from the regulated community, members of Congress, and other interested persons on regulatory and scientific issues.
Travel Required

Not required

Supervisory status

No

Promotion Potential

13

  • #### Job family (Series)

0301 Miscellaneous Administration And Program

  • Requirements

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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 males born 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 Counsel falls within the 0301 occupational series. To qualify for this position at gradeGS-**13, you must meet Time-in-Grade requirements by 11:59 pm EST on 10/23/2018.

Minimum Qualification Experience:

GS-13:**Applicants must have one year of specialized experience, equivalent to the GS-12 in the Federal service to include: (1) Developing policy statements and proposals for regulations that result in new legislation or new interpretations of existing legislation; (2) Responding to correspondence pertaining to regulatory and scientific issues, such as legal pleadings and briefs, legal opinions, legal memoranda and press releases, related to regulatory requirements; and (3) Representing the office at conferences and meetings to communicate regulatory policy developments.

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.

You must submit supporting documentation to verify your eligibility to apply for this vacancy. For internal applicants an SF-50 will be required. See the Required Documents section for full details.

Education
Additional information

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
  • If you are serving, or have served in the last 5 years (from 10/23/2018) 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 All requirements must be met by the closing date of this announcement (10/23/2018); 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.

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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 10/23/2018), 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.

  1. Technical Competency-Regulatory Counsel
  2. Written Communication
  3. Oral Communication

**To preview the application questionnaire, clink the link below.

https://apply.usastaffing.gov/ViewQuestionnaire/10321558**

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Background checks and security clearance
Security clearance

Q - Nonsensitive

Drug test required

No

  • Required Documents

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Required Documents

The following documents are REQUIRED for this vacancy: * Resume * SF-50 * Transcript "Required" indicates that the above documents are necessary to determine your eligibility and/or qualification for this vacancy. These documents are collected from ALL applicants and failing to provide any of these documents may result in your application being deemed incomplete or ineligible. 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.

RESUME REQUIREMENTS:

The Federal Government has very specific requirements for the information that you must include in your resume. A resume for a Federal job will be much longer and more complete than the type of resume you may be familiar with from the private sector, especially if you are accustomed to using the CV (curriculum vitae) format. If you have not written a Federal resume before, you may want to watch this Resume Writing Tutorial video on the USAJOBS YouTube channel, or read through a helpful Resume Writing FAQ article on the USAJOBS Help Site to learn what details you should, and should not, include in your resume. At a minimum, you should include: start and end dates for each position (including month and year), number of hours per week worked, level of experience and duties performed, employer name and address, supervisor name and contact, and salary (or grade and step), for each position listed in your work history.

The following documents are ACCEPTED for this vacancy: * Cover Letter * Other * Resume * SF-50 * Transcript "Accepted" means that you will have the opportunity to submit these documents if they are applicable to you. Such documents include Veteran Preference or other special eligibility documentation, transcripts, or other optional documentation that helps us determine your eligibility. The above list of documents may not apply to all applicants.

FDA EMPLOYEE DOCUMENTATION REQUIREMENTS FOR SF-50:

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. If you do not submit an appropriate SF-50, we cannot verify your status eligibility!

  1. Full position title;
  2. Appointment type;
  3. Occupational series;
  4. Pay plan, series, grade, and step;
  5. Tenure code; and
  6. Service Computation Date (SCD). If your current position SF-50 does not indicate you have competitive service status or does not reflect the pay plan and grade of the highest position you have held in the competitive service, in addition to your current SF-50, you must provide your previous SF-50s that provide the proof of competitive status and highest grade held on a permanent basis.

Displaced Federal employees who qualify for CTAP: If you are a former FDA employee, involuntarily separated (displaced) due to a Reduction-in-Force (RIF), please submit a copy of the separation letter or RIF notice you received from the agency. To be selected under CTAP, you must still be found well-qualified for this position. Please see USAJOBS Career Transition Programs site for more information.

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.

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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.

  • How to Apply

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How to Apply

To apply for positions with the Food & Drug Administration, you must have a USAJOBS Login.GOV account and be signed in to that account before you click the "Apply Online" button. See the USAJOBS Help Article "How does the application process work?" for more on this process.Additionally, you must provide a resume 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,10/23/2018. 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 closing 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: https://www.usajobs.gov/Help/how-to/. Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Help site at: https://www.usajobs.gov/Help/. FDA's Applicant Help Desk cannot assist you with 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 you encounter any difficulty with the site, we recommend that you visit the Applicant HELP Site at: https://help.usastaffing.gov/Apply/index.php?title=Applicant. 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 888-478-4340, or e-mail QuickQuestions@fda.gov. 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) 10321558 so that we may assist you faster.

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Agency contact information
FDA Applicant Help Desk
Phone

888-478-4340

Email

quickquestions@fda.gov

Address

Center for Drug Evaluation and Research 10903 New Hampshire Ave Silver Spring, MD 20993 US

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Next steps

Once you submit your application 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 application status updates via email and via USAJOBS as the process unfolds. How to check your application status and understand what each status means. How the application process works.

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  • 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

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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.

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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 www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/GetJob/ViewDetails/512633900. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.

Open & closing dates: 10/10/2018 to 10/23/2018

Service: Competitive

Pay scale & grade: GS 13

Salary: $96,970 to $126,062 per year

Appointment type: Permanent

Work schedule: Full-Time