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Supervisory Interdisciplinary Scientist

Department of Health and Human Services
Food and Drug Administration
This job announcement has closed

Summary

This position is located in the Department of Health and Human Services, Food and Drug Administration, Office of Medical Products and Tobacco, Center for Drug Evaluation and Research, Office of Translational Sciences, Office of Clinical Pharmacology, Division of Pharmacometrics, located in Silver Spring, MD.

This vacancy is also being announced concurrently with vacancy announcement FDA-CDER-18-MP-10080304JJ under merit promotion procedures. Please review that announcement to see if you are eligible for consideration under merit promotion procedures. Applicants must apply separately for each announcement in order to be considered under both.

Additional selections may be made within the same geographical area FDA-wide.

Overview

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Hiring complete
Open & closing dates
02/16/2018 to 03/01/2018
Salary
$134,789 - $164,200 per year
Pay scale & grade
GS 15
Location
Silver Spring, MD
Few vacancies
Travel Required
Not required
Relocation expenses reimbursed
No
Appointment type
Permanent
Work schedule
Full-Time
Service
Promotion potential
15
Supervisory status
Yes
Announcement number
FDA-CDER-18-DE-10081017JJ
Control number
491597100

Duties

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This position will serve as the Deputy Director and will have the following responsibilities:

  • Plan, manage, organize, and direct all regulatory review operations, program segment(s), functions, and activities of the Division as carried out by subordinate team leaders and a staff (scientific, engineering, medical, statistical, science, and/or veterinary medical officer) of professionals organized into either formal or informal subordinate organizations responsible for the regulatory review mission of the Division.
  • Ensure that reviewers provide quality review and consultation to customers within established timeframes for the science and administration functions of the Division.
  • Evaluate budget, fiscal, and administrative controls to manage Division program segments and services.
  • Play a key leadership role in critical industry meetings, identifies issues related to pharmacometrics and collaborates with other disciplines to ensure that key questions and drug development issues are addressed.
  • Lead the preparation, clearance, and finalization of Division responses to inquiries covering all aspects of the programs, functions, and activities of the Division.
  • Provide oversight of the development of CDER's model-informed drug development initiatives, including services and operations in support of regulatory activities.
  • Serve as a full deputy to the Director in the absence of the Director, for all areas of responsibility assigned to the Director.

Requirements

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Conditions of employment

  • Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement.
  • Selective Servie Registration: All males born on, or after, 12/31/1959, must be registered with the Selective Service OR have an approved exemption.
  • FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine employment eligibility. If a discrepency arises, you must take affirmative steps to resolve the problem.
  • Security and Background Requirements: Appointment will require passing a background investigation. Not meeting this requirement may be grounds for personnel action. If hired, you may be have a background check at a later time.
  • Certification of Accuracy: All information concerning qualification for employment is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection or appropriate disciplinary action.
  • Direct Deposit: You will be required to have your federal salary payments electronically deposited into an account with a financial institution of your choice.
  • 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.

Qualifications

In order to qualify for the Supervisory Interdisciplinary Scientist GS 0401/0405-15 , you must meet all requirements listed below by 03/01/2018.

Basic Requirement Biologist, GS- 0401;
Must possess a degree in biological sciences, agriculture, natural resource management, chemistry, or a related discipline. (You must submit transcript at time of application submission)
OR
Must possess coursework equivalent to a major as shown in A above plus additional education or appropriate experience. (You must submit transcript at time of application submission).

Basic Requirement Pharmacologist, GS- 0405;

Must have successfully completed a full four-year of study at an accredited college or university leading to a bachelor's or higher degree in an appropriate biological, medical, veterinary, or physical science, or in pharmacy that included at least 30 semester hours in chemistry and physiology and 12 semester hours in pharmacology.

In addition to meeting the Basic Requirements listed above you must also meet the following:

Minimum Qualifications GS-0401/0405-15:Must have one year specialized experience, equivalent in complexity and difficult to at least the GS-14 grade level in the Federal Service that include leading program operations of drug products and quality during the lifecycle of both brand and generic products; developing policy and providing scientific evaluation of processes and facilities for new drug and generic drugs; evaluating program performance and developing actions to ensure attainment of program goals; and managing or directing staff.

Education

You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. 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. For further information, click on foreign education.

Additional information

ADDITIONAL CONDITIONS OF EMPLOYMENT:

  • If you are serving, or have served in the last 5 years (from 03/01/2018) 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 Appointee FAQ - OPM
  • Incentives may be authorized; however, this is contingent upon funds availability.
  • Pre-Employment Physical: NO
  • Drug Testing Requirement: NO
  • License Requirement: NO
  • Immunization Requirement: NO
  • Mobility Agreement Required: NO
  • Bargaining Unit Position: NO
  • Veteran's Preference: If you plan to apply for any time of Veterans Preference, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. USAJOBS Veterans Site.
  • Selective Service Registration: Males born after December 31, 1959 must be registered or exempt from Selective Service. You can learn more by visiting the Selective Service Registration site.
  • Schedule A: If you plan to apply under Schedule A based on a disability, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. Disability Employment
  • Inter-agency and Career Transition Assistance Programs: If you are a displaced Federal employee and plan to apply under CTAP or ICTAP, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. Workforce Restructuring.
  • Financial disclosure statement, OGE-450, required: Please be advised that this position will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers..

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 03/01/2018), 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.
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.
Please follow all instructions carefully. Errors or omissions may affect your eligibility.

Basis of Rating: Category rating procedures 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 assigned to one of the following quality categories: Best Qualified, Well Qualified, or Qualified.
The Category Rating Process does not add veteran's preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 10 percent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher).

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

  • Program Management
  • Advisory Assistant
  • Administrative and budgetary Knowledge
  • Supervision and leadership
  • Communications
To preview the application assessment questions, use the link below:
https://apply.usastaffing.gov/ViewQuestionnaire/10081017

Food and Drug Administration

Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.

To learn more about the FDA mission, visit: https://www.fda.gov/aboutfda/workingatfda/default.htm

Agency contact information

FDA Applicant Help Desk
Phone
888-478-4340
Email
quickquestions@fda.gov
Address
FDA Center for Drug Evaluation and Research
10903 New Hampshire Ave
Silver Spring, MD 20993
US

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