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

Job Title:Pharmacologist

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-CDER-MP-13-858099

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

The contents of the announcement can still be viewed.

SALARY RANGE:

$105,211.00 to $136,771.00 / Per Year

OPEN PERIOD:

Monday, April 01, 2013 to Friday, April 12, 2013

SERIES & GRADE:

GS-0405-14

POSITION INFORMATION:

Full Time - Permanent

PROMOTION POTENTIAL:

14

DUTY LOCATIONS:

3 vacancies in the following location:
Rockville, MD United StatesView Map

WHO MAY APPLY:

Status Candidates (Merit Promotion and VEOA Eligibles)

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.

 

As a Pharmacologist in the Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), Division of Bioequivalence, you will work with a multi-disciplinary scientific/medical team that reviews, evaluates and decides on the approvability of regulatory submissions and applications that request FDA regulatory consideration for clinical research, testing and manufacturing of human drugs, or any other related regulatory submissions to FDA.

 

This position is located in the Department of Health and Human Services, Food and Drug Administration; (FDA), Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD); Rockville, MD.

 

This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-CDER-DE-13-858155 open to all U.S. Citizens from April 1 - 5, 2013.  Please review that announcement to see if you are eligible for consideration under competitive procedures.  NOTE:  Applicants must apply separately for each announcement in order to be considered.

 

 

This job opportunity announcement may be used to fill additional vacancies.

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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Compiling reviews of scientific studies related to pharmacokinetics and biopharmaceutics and preparing comprehensive summaries of data and performing independent timely and high quality reviews of generic product applications.

 

Evaluates the results of pharmacological  studies in support of Investigational New Drug Applications (INDs), and Abbreviated New Drug Applications (ANDAs), including amendments and supplements.

 

Serves as a CDER resource for information on current concepts in pharmacology and bioequivalence.

 

Prepares comprehensive summaries of data reviewed, including in vivo bioequivalence studies.


QUALIFICATIONS REQUIRED:

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Basic Qualification Requirement:

 

You must meet the following Basic Qualification Requirement:  Possess of 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.) Transcript(s) must be submitted with application package prior to the close date of the announcement.

 

 

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

 

Additional Qualification Requirement, GS-14:  At least one year of specialized experience equivalent to the GS-13 grade level in the federal Government (can be obtained in the public or private sector). This experience includes: providing authoritative pharmacology and regulatory guidance for the review of Abbreviated New Drug Applications and Investigational New Drug Applications, with a focus on in vivo bioequivalence evaluation of generic drugs; analyzing scientific studies, and their results, related to pharmacokinetics and biopharmaceutics; developing summaries of data reviewed, including conclusions and recommendations; and advising drug sponsors/applicants on the acceptance and implementation of recommendations based on the review of bioavailability/bioequivalence study data.

 

 

 

NOTES:                  

·         Education in lieu of experience is not qualifying to meet the additional qualification requirement for this position.

·         Part-time work is prorated in crediting experience (e.g., if you work 20 hours per week for a 12-month period you will be credited with 6 months of experience).


If you are claiming education as any part of your qualifications 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.  Degree requirements must be met within 30 days of the closing date of this job announcement and your  transcript(s) submitted must reflect this.

This position requires that specific course(s) be demonstrated to meet the basic education requirement.  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.

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

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 on foreign education

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

Conditions of Employment:

 

1. Time-in-Grade: Career or career-conditional current and former Federal employees who select to apply under merit promotion procedures must have served 52 weeks at the next lower grade level of this position.

2.  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.

3. 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.

 

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

 

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

 

6. Financial disclosure statement may be required.

 

7. One-year probationary period may be required.

 

8. Travel, transportation, and relocation expenses will be paid:  No

 

9. Bargaining Unit Position: Yes

 

10. Drug Screening Required:  No

 

11. Recruitment incentives may be authorized:  No

 

12. Student loan repayment incentive authorized:  No

 

13. 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.

For Competitive Merit Promotion and Veterans Employment Opportunities Act (VEOA) Applicants:  The highest rated candidates will be referred to the hiring agency.

For Noncompetitive Applicants:  All qualified candidates will be referred to the hiring agency.

The assessment questionnaire is designed to measure the following competencies that are required for this position:

  • PHARMACOKINETIC AND BIOPHARMACEUTIC STUDIES
  • INTERPRET AND EVLAUATE PHARMACOLOGY STUDIES
  • ORAL COMMUNICATION
  • WRITTEN COMMUNICATION

 

          

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 Employment Opportunities Act (VEOA): To be eligible for a VEOA appointment, the veteran must 1) be a preference eligible; or 2) be a veteran separated after 3 or more years of continuous active service performed under honorable conditions (you must submit a DD214-member copy 4).

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 what documents to submit as a CTAP/ICTAP eligible, go to: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 Friday, April 12, 2013 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
  • Standard Form 50 (if you are a current or former Federal service employee)
  • College transcripts that reflect the required degree or coursework.

 

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

 

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

 

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

1. Print out a Fax Cover Page @ http://staffing.opm.gov/pdf/usascover.pdf and complete the required information. The Vacancy ID is 858099

2. Fax a Cover Page with each supporting document to 1-478-757-3144 by 11:59 PM (EST) on Friday, April 12, 2013 to receive consideration. Keep a copy of your fax confirmation in the event verification is needed.

 

APPLICATION MATERIALS MUST BE RECEIVED BY 11:59PM (EASTERN TIME) ON THE CLOSING DATE OF THIS ANNOUNCEMENT

 

For 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-MP-13-858099

Control Number:

340060400