Food and Drug Administration Deputy Director for Regulatory Science in Silver Spring, Maryland

  • Duties

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Duties
Summary

The Office of Science Deputy Director for Regulatory Science serves as one of two Deputies. Represents the Center in the scientific community and with other Government organizations that share mutual responsibilities and interests in the field of tobacco science and public health. The incumbent supervises Division Directors with the Office of Science and oversees the Exemption Request, Substantial Equivalence, and Investigational Tobacco Product application review programs.

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Responsibilities
  • The Deputy Director for Regulatory Science carries out the responsibilities of the position by:
  • Serving as a principal advisor to the Center Director, in the absence of the Office of Science Director, on tobacco-related science and research matters which impact Center policy, direction, and long-range program goals.
  • Providing executive leadership and managerial direction to professional, technical, and support staff engaged in a variety of substantive activities related to tobacco science programs.
  • Providing recommendations on public health policies based on scientific merit, soundness of reasoning, relative priorities, availability of resources, and anticipated results.
  • Meeting with program managers from the FDA offices to discuss present and emerging issues of major impact and collaborates with internal and external stakeholders to establish a recommended course of action necessary to address the issues.
  • Providing information about Office of Science activities and policies to Congress, including expert advice on scientific matters related to existing and proposed policies, programs, regulations, proposed legislation, and legislative strategy.
  • Reviewing the Office of Science organizational structure and delegations of authority to subordinates in the Office in order to implement delegations of authority to maintain the most efficient operations.
  • Representing the Office, Center, and FDA on committees and at professional meetings, both national and international, making commitments, suggestions and recommendations concerning programs and policies related to tobacco science.
  • Directing the personnel actions, career development, and employee counseling associated with the supervisory responsibilities for Office staff.
  • Reviewing and evaluating the operating policies and procedures for the Exemption Request, Substantial Equivalence, and Investigational Tobacco Product application review programs to assure consistency across these programs.
  • Modifies the operating policies and procedures in order to obtain the most efficient and effective operations.
  • Overseeing the Center's tobacco regulatory research program to address short- and long-term research priorities.
  • Collaborating with stakeholders on tobacco research, such as NIH, CDC, contract labs, and academic researchers.
Travel Required

Occasional travel - 5 to 10% (Occasional Foreign and Domestic Travel is required.)

Supervisory status

Yes

Promotion Potential

00

  • #### Job family (Series)

0601 General Health Science

  • Requirements

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Requirements
Conditions of Employment
  • Males born on, or after, December 31st 1959 must be registered with the Selective Service System or have an approved exemption. Visit www.SSS.gov for more info.
  • Veterans Preference DOES NOT APPLY to positions, such as this one, advertised under Title 42-F hiring regulations.
  • You must be a U.S. Citizen to apply for this job.
Qualifications

BASIC QUALIFICATION REQUIREMENTS:

Candidates must have a master's degree (e.g., M.S., M.A., M.P.H.) or doctoral-level degree from an accredited institution of higher learning, such as a Ph.D., M.D., D.V.M., D.D.S., D.M.D., Sc.D., or other research doctoral-degree widely recognized in U.S. academe as equivalent to a Ph.D.

MANDATORY QUALIFICATIONS:

  1. Candidates must meet the minimum qualification requirements for the GS-15 and beyond in the civil service.
  2. Knowledge of and experience regarding tobacco control policy in a scientific organization.
  3. Knowledge of and skill in tobacco product and tobacco use research, synthesis and analysis of scientific information to inform the development of regulations and marketing application review. DESIRABLE QUALIFICATIONS:

  4. Experience leading a scientific organization.

  5. Extensive knowledge of tobacco product regulations, policy, and research.
  6. Familiarity with the application of FDA laws and regulations, including the Tobacco Control Act.
  7. Broad familiarity with regulatory science.
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 further information, visit the U.S. Department of Education website for Foreign Education Evaluation.

Additional information

Additional Conditions of Employment:

  1. Security and Background Requirements: This position requires a Public Trust Clearance. If not previously completed, a background security investigation will be required for all appointees. Appointment will be subject to the applicant's successful completion of a background security investigation and favorable adjudication of a Public Trust Clearance. Failure to successfully meet these requirements may be grounds for appropriate personnel action. Applicants are also advised that all information concerning qualification is subject to investigation. False representation may be grounds for non-selection and/or appropriate disciplinary action. Failure to obtain and maintain the required level of clearance may result in the withdrawal of a position offer or removal.
  2. E-Verify:The U.S. Department of Health and Human Services is an E-Verify Participant. If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "E-Verify" System. Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system.
  3. Financial disclosure statement may be required. FDA inspires public confidence by maintaining high ethical principles, and all Federal Government employees are subject to the conflict of interest statutes and regulations, including the Standards of Ethical Conduct, that govern activities with outside organizations and reporting financial holdings. Certain positions within the FDA are subject to strict restrictions on financial holdings (FDA regulated financial holdings). The Ethics in Government Act, PL 95-521 also requires the applicant selected for this position to submit a Public Financial Disclosure Report, OGE-450, prior to assuming this position, annually, and upon termination of employment. To determine how this position is affected, applicants are advised to seek additional information during the interview process from the Ethics and Integrity Staff, Division Management Programs at (301) 796-8435 prior to accepting such a position.
  4. Prohibited financial interests restrictions apply: Employees designated as public or confidential filers, and their spouse or minor children, may not hold financial interests in FDA significantly regulated organizations.
  5. Outside activity restrictions apply: Requests for approval of outside activities may be required prior to participation in certain outside activities and outside employment. Employees designated public or confidential filers may not have outside activity, unpaid or paid, with FDA significantly regulated organizations.
  6. Bargaining Unit status: Non-Bargaining
  7. Incentives may be authorized:This is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in FDA 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.

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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 ET on 07/10/2018, 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 Federal employment, and then whether or not you are qualified for this particular position.

Qualification determinations will be based on the information provided in your application and the requirements of the position. Please follow all instructions carefully. Errors or omissions may affect your eligibility.

Structured interviews: Applicants may be asked scenario-based interview questions concerning core competencies. Method/tools used to evaluate applicants: Work samples, conducting a presentation, reference checks, tests may be used.

To preview the assessment questionnaire, click this link: https://apply.usastaffing.gov/ViewQuestionnaire/10175002

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Background checks and security clearance
Security clearance

Public Trust - Background Investigation

  • Required Documents

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Required Documents

The following documents are REQUIRED:

As noted above under Qualifications, all applicants are required to submit the following supporting document type(s):

  • Resume.
  • Transcripts (unofficial transcripts/foreign education evaluation are acceptable at time of application).

If you have questions about the documentation requirements, please contact the FDA Applicant Help Desk and reference VIN# 10175002. The help desk contact info is listed on this announcement.

If you need help attaching a document to your application, please review the instructions: Applicant Help Site - Documents

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 this position, you must complete the assessment questionnaire and submit all documentation specified in the Required Documents section below. To receive consideration for this position you must submit your complete application by 11:59 pm Eastern Time on the closing date of this announcement07/10/2018

You must have a Login.GOV-enabled USAJOBS account to apply for jobs with the U.S. Government. Before you can apply, you must be signed in to your USAJOBS account. If you need assistance with any part of the application process, please visit the following support links:

  • USAJOBS - How To - Searching & Applying for Jobs, Managing Your Account, & more!
  • Applicant Help Site - Submitting an Application, Attaching Documents, and more!
  • How to Apply for Federal Jobs - YouTube Tutorial by OPM You are encouraged to apply online. Applying online will allow you to review and track the status of your application and receive status notifications. However, if you are not able to apply online due to extenuating life circumstances or disability, this agency provides reasonable accommodations on a case-by-case basis. If you need a reasonable accommodation for any part of the application and hiring process, please contact the FDA Applicant Help Desk at (888) 478-4340; TTY/TDD: (800) 877-8339; or by email quickquestions@fda.gov. (In your e-mail request, please replace the blank line with the Vacancy Identification Number, VIN, for this job, which is:10175002. Decisions for granting a reasonable accommodation will be made on a case-by-case basis. The Applicant Help Desk operates between the hours of 7am to 6pm Eastern Time, Monday through Friday (except government holidays).

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Agency contact information
FDA Applicant Help Desk
Phone

888-478-4340

Email

quickquestions@fda.gov

Address

Center for Tobacco Products 10903 New Hampshire Ave Silver Spring, MD US

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Next steps

Once the online questionnaire is received 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 will strive to make a selection within 120 days of the closing date of this announcement. You will be notified of the outcome by e-mail using the e-mail address on file in the Application Manager system, or by postal mail if no email address was provided by you during the application process.

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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/501993000. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.

Open & closing dates: 06/11/2018 to 07/10/2018

Salary: $105,123 to $275,000 per year

Pay scale & grade: RF 00

Work schedule: Full-Time

Appointment type: Permanent