This Position Is No Longer Available
  1. Overview
  2. Duties
  3. Qualifications & Evaluations
  4. Benefits & Other Info
  5. How to Apply

Job Title:Pharmacologist, GS-405-13

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-CDER-DE-14-1027413

This position is closed and no longer accepting online applications through USAJOBS.

The contents of the announcement can still be viewed.

SALARY RANGE:

$89,924.00 to $116,901.00 / Per Year

OPEN PERIOD:

Friday, January 24, 2014 to Thursday, June 26, 2014

SERIES & GRADE:

GS-0405-13

POSITION INFORMATION:

Full Time - Permanent

DUTY LOCATIONS:

Many vacancies in the following location:
Rockville, MD View Map

WHO MAY APPLY:

United States Citizens

SECURITY CLEARANCE:

Not Applicable

SUPERVISORY STATUS:

No

JOB SUMMARY:

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.

AMENDMENT: The closing date has been extended to 6/26/2014.

This announcement is open continuous till the closing date with the following cut-off dates for certification:

  • 2/22/2014
  • 3/24/2014
  • 4/25/2014
  • 5/27/2014
  • 6/26/2014
    As a Pharmacologist in the Immediate Office of the Director, Office of Generic Drugs, you will provide scientific expertise in the area of biopharmaceutics and pharmacokinetics; consult with the Director for Science on the use of computers in statistical pharmacokinetics analyses; apply in-depth knowledge of chemistry, pharmacokinetics, physiology, pharmacology, pharmacy, and medical science in resolving complex review issues; and develop generic drug standards.

 

This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-CDER-MP-14-1027419 under merit promotion procedures.  Please review that announcement to see if you are eligible for consideration under merit promotion procedures.  NOTE:  Applicants must apply separately for each announcement in order to be considered.

 

This job opportunity announcement may be used FDA-wide to fill additional vacancies within the same geographical location.

TRAVEL REQUIRED

  • Not Required

RELOCATION AUTHORIZED

  • No

KEY REQUIREMENTS

  • U.S Citizenship
  • Suitability for Federal employment determined by background investigation
  • May be required to serve a one-year probationary period

DUTIES:

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  • Reviews a wide range of drug applications received from the pharmaceutical industry to determine the adequacy of bioequivalence sections.
  • Evaluates innovations in physico-chemical in vitro technology for monitoring drug quality, developing new human drug evaluation protocols, and evaluating data by sophisticated, statistical and pharmacokinetic computer analyses.
  • Conducts and manages research to develop new bioavailability and bioequivalence standards and improve existing standards.
  • Consults on the evaluation of drug bioavailability and pharmacokinetic data.
  • Prepares responses to petitions and other correspondence inquiries on matters related to the bioequivalence of generic drugs.
  • Plans, directs, implements, and evaluates complex issues in a regulatory research.


QUALIFICATIONS REQUIRED:

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You must meet the following Basic Qualification Requirement: Possess a bachelor's degree or higher 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. (Courses in chemistry, organic chemistry, biochemistry, general physiology, and animal, human, microbial, or cellular physiology may be used to meet the 30-semester hour requirement in chemistry and physiology. Courses in pharmacology, pharmacodynamics, pharmacotherapy, molecular pharmacology, and other similar subjects may be used to meet the 12-semester hour requirement in pharmacology. Courses dealing intensively with pharmacologically-oriented subjects may also be used to meet this requirement.)

You must also meet the following Additional Qualification requirement to be considered for this position:

Additional Qualification Requirement, GS-13: At least one year of specialized experience, equivalent in complexity and difficulty to the GS-12 grade level in the Federal service (can be obtained in the public or private sector), performing all of the following: 1) conducting pharmacokinetic analysis on the bioequivalence of drug products; 2) advising on research development and production of drugs for human use; 3) designing and analyzing bioavailability/bio-equivalence studies, and recommending acceptability of tests and data; 4) developing guidelines/standards for drug studies; and 5) communicating study findings and regulatory information verbally and in writing to scientific staff and pharmaceutical industry representatives.


This position requires specific coursework and/or a degree to meet the basic education requirement. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.Your transcript(s) must clearly demonstrate the course(s) listed in the qualification requirement section. If the transcript(s) does not clearly demonstrate this you must submit a copy of the course description and/or other documentation demonstrating that the courses are equivalent. Degree requirements must be met within 30 days of the closing date of this job announcement and your transcript(s) submitted must reflect this.

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. For further information,click onforeign education

All qualification requirements must be met by 11:59 PM (Eastern Time) on the closing date of this vacancy announcement.

Failure to provide any of the above will result in an ineligible rating.

Conditions of Employment:

1. Security and Background Requirements: 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. Failure to successfully meet these requirements may be grounds for appropriate personnel action. In addition, if hired, a background security reinvestigation or supplemental investigation may be required at a later time. Applicants are also advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-consideration, non-selection and/or appropriate disciplinary action.

2. E-Verify: 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. The U.S. Department of Health and Human Services is an E-Verify Participant.

3. Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.

4. All qualification requirements must be met by the closing date of the announcement.

5. Financial Disclosure statement may be required.

6. One-year probationary period may be required.

7. Travel, transportation, and relocation expenses paid: No

8. Bargaining Unit Position: Yes

9. Drug Screening Required: No

10. Recruitment incentives may be authorized: No

11. Student loan repayment incentive authorized: No

12. Annual leave for non-federal service authorized: No

HOW YOU WILL BE EVALUATED:

Once the job opportunity announcement closes, a review of your résumé and supporting documentation will be made and compared against your responses to the assessment questionnaire to determine if you are qualified for this job.

If, after reviewing your résumé and supporting documentation, a determination is made that you have inflated your responses when compared to your background information, 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.

Qualified candidates will be assigned to the following quality categories:

Best Qualified - Applicants who have experience that is almost identical to those required by the position.

Well Qualified - Applicants who have experience that is very similar to those required by the position.

Qualified - Applicants who meet minimum qualification requirements, but do not identify any additional qualifying experience or skill.

The category assignment is a measure of the degree in which your background matches the required competencies listed below for this position.

  • Pharmacokinetic/Biopharmacokinetic Studies
  • Scientific Analysis
  • Written Communication
  • Verbal Communication
  •  

    Application of Veterans' Preference: Under Category Rating procedures, veteran preference eligibles will receive selection consideration before non-preference eligibles within each quality category.

    To preview the assessment questionnaire, click the following link: View Assessment Questions


    BENEFITS:

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    The Federal government offers a comprehensive benefits package.  Explore the major benefits offered to most Federal employees at http://www.opm.gov/retire/retire_jobseekers.asp.



    OTHER INFORMATION:

    Veterans' Preference: If you are a veteran claiming 5-point veterans' preference, you must submit a copy of your DD-214 (Member Copy 4) or an official statement (including Character of Service) from your command if currently on active duty. If you are claiming 10-point veterans' preference, in addition to the DD-214, you must also submit a Standard Form 15 (Application for 10-Point Veteran Preference) and the required supporting documents listed on that form. For more information on veterans' preference, go to www.fedshirevets.gov

    Career Transition Program: This program applies to Federal workers whose positions have been deemed 'surplus' or no longer needed, or an employee has been involuntarily separated from a Federal service position within the competitive service. To receive selection priority for this position, you must be rated 'well-qualified.  Well-qualified means eligible applicants whose knowledge, skills, and abilities clearly exceed the minimum qualification requirements of the position. For information on how to apply and hat documents to submit as a CTAP/ICTAP eligible, go to: http://www.opm.gov/rif/employee_guides/career_transition.asp

    Selective Service:  The Defense Authorization Act of 1986 requires that all male applicants born after 12/31/59 who are required to register under the Military Selective Service Act, be registered or they are not eligible for appointment to this position.  For further information concerning Selective Service requirements, please visit http://www.sss.gov/.



    HOW TO APPLY:

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    To apply for this position, you must complete the occupational questionnaire and submit the documentation specified in the Required Documents section below.

    The complete application package must be submitted by 11:59 PM (EST) on Thursday, June 26, 2014 to receive consideration.

    * To begin, click Apply Online to create a USAJOBS account or log in to your existing account. Follow the prompts to select your USAJOBS resume and/or other supporting documents and complete the occupational questionnaire.

    * Click the Submit My Answers button to submit your application package.

    * 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 and click 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.

    To return to an incomplete application, log into your USAJOBS account @ https://my.usajobs.gov/Account/Login  and click Update Application in the vacancy announcement.  You must re-select your resume and/or other documents from your USAJOBS account or your application will be incomplete.

    To complete a hard copy assessment questionnaire and submit it via fax: Do not complete the steps below if you have already applied online to the questionnaire for this position.

    1) Print the instructions and questionnaire by clicking View Occupational Questionnaire.

    2) Print the 1203FX form to record your responses to the questionnaire.

    3) Fax the completed 1203FX (all 6 pages but do not include a Cover Page for this document) to: 

    1-478-757-3144



    REQUIRED DOCUMENTS:

    • Your Résumé - You are encouraged to use the USAJobs online resume builder to ensure that all required information is in your resume. If you use your own résumé, curriculum vitae, or any other written form you choose then you must describe your job-related qualifications that include beginning and ending dates for paid and non-paid work experience, hours worked per week, month and year of employment for each job title listed.
    • Responses to the Assessment Questionnaire
    • College transcripts (to support the Basic Requirement)

    Other Supporting Documents: (Only submit if applicable to you.)

    • Veterans' Preference documentation (i.e. SF-15, DD-214, Statement of Service, Service Connected Disability Letter, etc. ) 
    • CTAP/ICTAP documentation

    If you are unable to upload supporting document(s) online, you can fax them by completing the following steps:

    1. Print out a Fax Cover Page @ http://staffing.opm.gov/pdf/usascover.pdf and complete the required information. The Vacancy ID is 1027413

    2. Fax a Cover Page with each supporting document to 1-478-757-3144 by 11:59 PM (EST) on Thursday, June 26, 2014 to receive consideration. Keep a copy of your fax confirmation in the event verification is needed.

    APPLICATION MATERIALS MUST BE RECEIVED BY MIDNIGHT (EASTERN TIME) ON THE CLOSING DATE OF THIS ANNOUNCEMENTFor Résumé and Application Tips visit: http://www.usajobs.gov/ResourceCenter/Index/Interactive/ResumeAndApplicationTips#icc

    AGENCY CONTACT INFO:

    Mid-Atlantic Services Branch
    Phone: (757)441-6765
    Email: NORFOLKMAIL@OPM.GOV
    Agency Information:
    HHS OPM
    1900 E St NW
    Washington, DC
    20415

    WHAT TO EXPECT NEXT:

    You will be notified of your status when the list of candidates has been referred to the hiring manager for employment consideration.


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    Job Announcement Number:

    HHS-FDA-CDER-DE-14-1027413

    Control Number:

    359359400