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

Job Title:Toxicologist

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-MP-13-930568

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:

Friday, August 16, 2013 to Friday, August 23, 2013

SERIES & GRADE:

GS-0415-14

POSITION INFORMATION:

Full Time - Permanent

PROMOTION POTENTIAL:

14

DUTY LOCATIONS:

Many vacancies in the following location:
Silver Spring, MD United StatesView Map

WHO MAY APPLY:

Current Career or Career Conditional within Office of New Drugs

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.

Who May Apply: 

Federal employees with career or career-conditional appointments in the competitive service within the Office of New Drugs (OND).

This position is located in the Center for Drug Evaluation and Research, Office Division.  SUBMIT YOUR SF-50.

PHS Commissioned Corps Officers that are interested in this position may appoy online.

There may be multiple positions filled in multiple locations.

KEY REQUIREMENTS

  • Applicants must be within the Office of New Drugs.
  • Applicants must submit a current SF-50
  • Applicants must submit transcripts.

DUTIES:

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Reviews and evaluates scientific submissions focusing on non-clinical in vitro and animal data and evaluation of toxicological potential of drugs in support of proposed clinical studies or proposed dosage regimens in the labeling.  This process includes evaluation of toxicological potential on all organ systems, tissues, and cells, and on the animal in general, as well as possible adverse-effects of drugs upon the processes of reproduction and on the offspring.  Often the carcinogenic potential must be evaluated.  The incumbent develops comments on labeling as it pertains to animal studies and probable safety in use of the drug for the proposed indications and at the recommended dosage.

 

Prepares comprehensive summaries and integrated discussions of data submitted for review and other available information.  Submits substantive regulatory recommedations and conclusions for concurrence by the scientific supervisor.

Meets with industry representative to exchange information and to provide advice and guidance regarding those aspects of the application, notice, amendment, supplement or report which fall within area of review, wth emphasis on non-clinical studies to support clinical studies or NDA or BLAs, as well as deficiencies in animal studies.

 

Provides leadership, guidance and/or regulatory expertise to address and solve complex regulatory issues consistent with technological developments or new scientific evidence, and provides innovative solutions to complex problems.

Attends meetings, conferences, and symposia of scientific organizations to remain aware and gain an understanding of developments in the field, to exchange ideas with other scientific peers engaged in related areas, and to acquire background information pertinent to the conduct of Divisional responsibilities.


QUALIFICATIONS REQUIRED:

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Basic Qualification: Successful completion of a full (4) year course of study in an accredited college or university leading to a bachelor's or higher degree that included a major field of study.  Degree: Toxicology; or an appropriate discipline of the biological, medical, or veterinary sciences that included at least 30 semester hours in chemistry, biochemistry, or physiology, and 12 semester hours in toxicology.

or

Combination of education and experience.

 

For the GS-14 level:  applicant must have one year at the next lower grade (GS-13) in the Federal Service.

Examples of specialized experience for the GS-13 level is as follows:  serving on 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 manufacture of human drugs.


Degree:  toxicology; or an appropriate discipline of the biological, medical, or veterinary sciences that included at least 30 semester hours in chemistry, biochemistry, or physiology, and 12 semester hours in toxicology.

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 not required.

6. One-year probationary period not required.

7. Travel, transportation, and relocation expenses will not be paid.

8. Bargaining Unit Position:Yes

9. Drug Screening Required: No

10. Recruitment Bonus may be authorized:No

11. Time in grade (TIG) must be met by closing date of the announcement.

HOW YOU WILL BE EVALUATED:

Once the application process is complete, a review of resume 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 resume and or supporting documentation, a determination is made that you have inflated your qualifications and or experience, you may lose consideration for this position.  Please follow all instructions carefully. Errors or omissions may affect your eligibility. 

Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics):

 

1. Knowledge of the broad fields of pharmacology and toxicology

 

2. Ability to advise others in the application of Agency rules, regulations, and procedures.

 

3. Ability to communicate in writing.

 

4. Ability to communicate orally.


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.usajobs.gov/ei/benefits.asp#icc.



OTHER INFORMATION:

If you are a veteran with preference eligibility and you are claiming 5-points veterans' preference, you must submit a copy of your DD-214 or other proof of eligibility. If you are claiming 10-point veterans' preference, you must also submit an SF-15, "Application for 10-Point Veterans' Preference" plus the proof required by that form. For more information on veterans’ preference see http://www.usajobs.gov/veterans.asp.

Males born after December 31, 1959 must be registered or exempt from Selective Service (see http://www.sss.gov).

For information on "People with Disabilities" please visit http://opm.gov/disability/PeopleWithDisabilities.asp

Interagency Career Transition Assistance Program (ICTAP):  For information on how to apply as an ICTAP eligible see http://opm.gov/rif/employee_guides/career_transition.asp#ictap.  To be well-qualified and exercise selection priority for this vacancy, displaced Federal employees must be rated at 85.0 or above on the rating criteria for this position.





HOW TO APPLY:

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To begin the process, click the Apply Online button to create an account or log in to your existing USAJOBS account. Follow the prompts to complete the assessment questionnaire. Please ensure you click the Submit My Answers button at the end of the process.

 

Note: To return to a previously Saved or Incomplete application you may use the following link: https://applicationmanager.gov/.

 

To fax supporting documents you are unable to upload, complete this cover page http://staffing.opm.gov/pdf/usascover.pdf using the following Vacancy ID 930568.  Fax your documents to 1-478-757-3144.

 

If you cannot apply online:

  1. Click the following link to view and print the assessment questionnaire View Occupational Questionnaire, and
  2. Print this 1203FX form to provide your response to the assessment questionnaire http://www.opm.gov/forms/pdf_fill/OPM1203fx.pdf  and
  3. Fax the completed 1203FX form along with any supporting documents to 1-478-757-3144. Your 1203FX will serve as a cover page for your fax transmission.
  4. 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 Rockville Center HelpDesk Telephone (888)-478-4340; TTY/TDD:  Rockville/Bethesda Use (800) 877-8339; Baltimore Use (410) 786-0727, email quickquestions@psc.gov; please contact the Customer HelpDesk Telephone (770) 488-1725; TTY/TDD: Atlanta Use (866) 539-4484; email HRCS@TARGET.CDC.GOV. The decision on granting reasonable accommodation will be made on a case-by-case basis.

The following documents are required and must be received by the closing date of this announcement:

1. Your Resume'
2. A complete Assessment Questionnaire
3. Other supporting documents:
    - Veterans Preference Documentation, if applicable
    - College transcript, if applicable

For Resume' and Application Tips visit: http://www.usajobs.gov/EI/resumeandapplicationtips.asp#icc



REQUIRED DOCUMENTS:

To apply for this position, you must provide a complete Application Package which includes:

 

1. Your Résumé

2. A complete Assessment Questionnaire

3. Other supporting documents:

         - Veterans Preference Documentation, if applicable
              - College Transcripts, if applicable

         - Submit SF-50, (including the highest grade held), if applicable

Note: You may submit an unofficial transcript or a list of college courses completed indicating course titles, credit hours, and grades received. An official transcript from an accredited educational institution is required if you are selected for the position.
 

The complete Application Package must be submitted by 11:59 PM (EST) on Friday, August 23, 2013.

AGENCY CONTACT INFO:

FDA Helpdesk
Phone: (888)478-4340
Fax: (478)757-3144
Email: QUICKQUESTIONS@PSC.GOV
Agency Information:
HHS NCR Center
200 Independence Ave SW
HHH Building
Suite 801
Washington, DC
20201 Fax: (478)757-3144

WHAT TO EXPECT NEXT:

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 expect to make a selection within 45 days of the closing date of this announcement.

You will receive notice via email or by mail, if no email address was provided by you during the application process, once this process is completed (generally 4-6 weeks).


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Job Announcement Number:

HHS-FDA-MP-13-930568

Control Number:

348053100