Duties

Summary

This Direct-Hire position is in the Food and Drug Administration, with multiple locations throughout the U.S. and its territories.
See the sections below for more details on the duties & qualifications for this position.

Note: Salary figures shown represent the "Rest of U.S." locality pay rate. Salaries may vary based on the actual location you are hired at. You can reference OPM's 2019 General Schedule (GS) Pay Tables site to see the current pay rates adjusted for each locality area.
Learn more about this agency

Responsibilities

• Serves as a regulatory lead on scientific project and/or review teams; ensures compliance with all legal, regulatory and policy requirements.
• Works with the review team (scientific, regulatory and management) to develop project plans.
• Manages the tobacco product review process from initial submissions to the time of regulatory action..
• Serves as contact point for communications concerning regulated product applications and other scientific projects.

Travel Required

Occasional travel - You may be expected to travel for this position.

Supervisory status
No

Promotion Potential
13

Requirements

Conditions of Employment

• This position may be subject to completion of a 1-year probationary period (unless you have already satisfied this obligation).
• Citizenship Requirement: You must be a U.S. Citizen or U.S. National to be considered for this advertisement. Foreign nationals or legal permanent residents are not eligible for consideration.
• Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.
• 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.
• 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.
• Research Positions may require evaluation of the scientific contributions, recognition, and professional standing of the researcher, and may be subject to peer review. A writing sample or publication portfolio may also be required.
• If you were born male, after, December 31st 1959, you must be registered with the Selective Service System, or have an approved exemption. Learn more at www.SSS.gov.
• 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. Your application may be shown to multiple hiring offices.
• You may be asked to provide additional information at a later time. All interviews requests and selection decisions are at the full discretion of the hiring office.
• 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.
• Telework is at the discretion of the supervisor.
• A one year probationary period may be required.

Qualifications

BASIC QUALIFICATIONS:
In order be eligible for the position of Regulatory Health Program Coordinator, (GS-0601-12/13) , you must meet the following requirements...

BASIC REQUIREMENT: This position has a Basic Individual Occupational Requirement (IOR). In order to meet the basic IOR you must possess a Bachelor's degree or higher graduate degree in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. You must submit an unofficial transcript to show that you meet the basic IOR in order to be considered for this position.

In addition to the Basic Individual Occupational Requirement (IOR) you must also meet the following specialized experience requirement:

For GS-12: You must possess 1 year of specialized experience equivalent at to the GS-11 grade level in the Federal service, applying knowledge of scientific methods and regulatory policies to formulate and manage regulated products research and review projects; applying project management principles in planning and organizing concurrent activities and anticipating subtle and difficult issues; and providing oral and written briefings and recommendations concerning projects.

For GS-13: You must possess 1 year of specialized experience equivalent to the GS-12 grade level in the Federal service,
applying knowledge of scientific methods and regulatory policies to formulate and lead regulated products research and review projects; applying project management principles to lead, manage and coordinate team activities; and providing technical guidance to resolve program problems.

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.

All qualification requirements must be met by 11:59 pm (Eastern Time) on 05/05/2020 . 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.

Education

If you are claiming education as any part of your qualification for this position, you must submit an official transcript, unofficial transcript, or a list including courses, grades earned completion dates and quarter and semester hours earned.

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.

Additional information

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.

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,3591
• Financial disclosure statement, OGE-450, required: Please be advised that this position may be subject to FDA's prohibited financial interest regulation and may require the incumbent of this position to divest of certain financial interests. Applicants are advised to seek additional information on this requirement from the hiring official before accepting this position.

Additional Information:

• If you are serving, or have served in the last 5 years (from 05/05/2020) 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. See Political Appointee FAQ - OPM for more..
• Reasonable Accommodation: This agency provides reasonable accommodation to applicants with disabilities. If you need a reasonable accommodation for any part of the application and hiring process, please contact the Bethesda Center Help Desk (888) 478-4340; TTY/TDD: (866) 539-4484; or by email quickquestions@fda.hhs.gov . The decision on granting reasonable accommodation will be made on a case-by-case basis. See the Reasonable Accommodation Policy for more information...
• Equal Employment Opportunity: 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 See the EEO Policy for more information...

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 05/05/2020), your resume and all supporting documents will be reviewed by HR to determine your eligibility for Federal employment and your qualification for this position specifically.

This is a direct hire announcement. Traditional rating and ranking of applications, and veterans' preference does not apply to this vacancy. We will evaluate you against the basic qualifications. Qualified applicants will be referred for consideration in accordance with the Office of Personnel Management direct hire guidelines.

Please follow all instructions carefully. Errors or omissions may affect your eligibility.

Background checks and security clearance

Security clearance
Other

Drug test required
No

Position sensitivity and risk
Non-sensitive (NS)/Low Risk

Trust determination process
Suitability/Fitness

Required Documents

• Resume
• Transcript

A document that is required must be submitted by all applicants because the document is needed to verify your qualifications, education, or other eligibility information. Failure to provide one of the documents in the list below may result in your application being considered incomplete.

• Cover Letter
• DD-214/ Statement of Service
• Disability Letter (Schedule A)
• Disability Letter (VA)
• License
• Licensure, Certification, etc.
• PCS Orders
• Performance Appraisal
• Professional Certification
• Resume
• Separation Notice (RIF)
• SF-15
• SF-50/ Notification of Personnel Action
• Transcript

These documents may be required for some applicants . Applicants relying on education to qualify, those seeking consideration under a special hiring authority, or those who need to verify a license or certification, will need to submit appropriate supporting documentation from this list. RESUME REQUIREMENTS:
The federal government has very specific resume requirements. If you have not written a federal resume before, you should watch this Resume Writing Tutorial video on the USAJOBS YouTube channel , or read through a helpful Resume Writing FAQ on the USAJOBS Help Site to learn what details you should, and should not, include in your resume.
At a minimum your resume should list the position title, employer, start and end dates (including month and year), salary (or grade and step), hours worked per week, and a list of duties performed or accomplishments, for EACH position listed. A CV (curriculum vitae) may not contain enough information to meet these resume requirements.

Learn more about supporting documents and documentation requirements on USAJOBS:

• How to Understand the Required Documents Section
• What Types of Documents May I Need?
• How to Manage Your Documents on USAJOBS

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.