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

Job Title:Interdiscplinary Scientist

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-CDRH-DE-14-1016487

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

The contents of the announcement can still be viewed.

SALARY RANGE:

$74,872.00 to $115,742.00 / Per Year

OPEN PERIOD:

Friday, December 20, 2013 to Friday, January 03, 2014

SERIES & GRADE:

GS-0403/0415/1320-12/13

POSITION INFORMATION:

Full Time - Permanent

PROMOTION POTENTIAL:

13

DUTY LOCATIONS:

Few vacancies in the following location:
Silver Spring, MD View Map

WHO MAY APPLY:

United States Citizens

SECURITY CLEARANCE:

Not Applicable

SUPERVISORY STATUS:

No

JOB SUMMARY:

The Food and Drug Administration - Protecting and Promoting Your Health

Help protect public health by joining the FDA's Center for Devices & Radiological Health (CDRH).  From reviewing applications for innovative medical devices to educating industry on relevant policies and regulations to providing accurate, science-based health information to the public, CDRH is at the forefront in ensuring the safety, efficacy, and security of the medical devices and radiation-emitting products that millions of Americans use daily.

 

One or more positions may be filled using this vacancy announcement.

TRAVEL REQUIRED

  • Occasional Travel
  • 1-5 nights per month

RELOCATION AUTHORIZED

  • No

KEY REQUIREMENTS

  • You must be a U.S. citizen or national to apply for this position.

DUTIES:

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As a Scientist in the Office of Device Evaluation, you will serve as the senior level reviewer of data in your scientific specialty field in order to determine the safety and efficacy of medical devices.  Duties include:

·          Reviewing scientific data submitted in support of a variety of medical device submissions (e.g. premarket applications, product development protocols, applications for investigational device exemptions, etc.) to determine its accuracy and sufficiency;

·          Reviewing research protocols used to evaluate medical devices and recommending new or modified methods for testing and data analysis;

·          Writing and evaluating guidelines concerning data submissions for medical devices and their marketing;

·          Making presentation to the medical/scientific panel members on the FDA Advisory Committee responsible for the classification and premarket review of medical devices; and

·          Drafting a variety of reports and summaries on the safety and effectiveness of devices submitted in a premarket approval application


QUALIFICATIONS REQUIRED:

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In order to be qualified for this position, you must meet the basic requirement(s) for the series for which you are applying.  

 

For the GS-0403 Microbiologist, you must possess one of the following:

A. Have successfully completed a four year course of study in an accredited college or university leading to a Bachelor's or higher degree in microbiology, biology, chemistry, or basic medical science that included at least 20 semester hours in microbiology or other subjects related to the study of microorganisms, and 20 semester hours in the physical and mathematical sciences combining course work in organic chemistry or biochemistry, physics, and college algebra, or their equivalent. - OR -
B. I possess education, which included courses equivalent to a major, as shown in A above, plus additional education or appropriate experience.

For the GS-0415 Toxicologist you must have successfully completed a four year course of study in an accredited college or university leading to a Bachelor's or higher degree in 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. (Courses in anatomy, chemistry, organic chemistry, biochemistry, biology, histology, and animal, human, microbial, or cellular physiology may be used to meet the 30-semester-hour requirement in chemistry, biochemistry, and physiology. Courses in statistics, bioassay, and test design may also apply to this requirement. Courses in cytology, embryology, cellular or microbial genetics, and biophysics may also be used to meet this requirement in those instances where the course work provided additional insight into the biophysical, biochemical, and physiological relationships involved. Only toxicology courses may be used to meet the requirement for 12 semester hours in toxicology. This may include courses dealing intensively with toxicological search, methods in toxicology, essentials of toxicology, the study and review of toxicological literature, special reading courses, or other toxicologically-oriented subjects.)

For the GS-1320 Chemist, you must possess one of the following:

A. A Bachelor's or higher degree in the physical sciences, life sciences, or engineering that included 30 semester hours in chemistry, supplemented by course work in mathematics through differential and integral calculus, and at least 6 semester hours of physics.  - OR -
B. A combination of education and experience. This includes course work equivalent to a major as shown in A above, including at least 30 semester hours in chemistry, supplemented by mathematics through differential and integral calculus, and at least 6 semester hours of physics, plus appropriate experience or additional education.

In addition, in order to be qualified at the GS-12 level, you must possess one year of specialized experience, equivalent to the GS-11 level in the Federal service, analyzing scientific data submitted by other scientists/researchers to provide feedback or advice on methods/procedures utilized; conducting research or briefings on the classification and scientific review of medical device products or other scientific systems/designs; modifying existing guidelines and protocols for scientific testing of medical device products or other scientific systems and designs; and providing information to researchers or scientists on guidelines, scientific, or regulatory requirements related to research on scientific products.

In addition, in order to be qualified at the GS-13 level, you must possess one year of specialized experience, equivalent to the GS-12 level in the Federal service, reviewing technical or complex data (e.g. related to multi-step processes, combination products, etc.) for scientific/research projects related to the accuracy, safety, or efficacy of a medical device or scientific system/process; providing advice and assistance to scientists in developing scientific and technical policies; reviewing research protocols to evaluate medical device products, scientific projects, or research assignments; and recommending solutions to scientific complaints, research discrepancies, and/or product problems.


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 on foreign education

All qualification requirements, other than education, must be met by 11:59 PM (Eastern Time) on the closing date of this vacancy announcement.  Degree/coursework requirements (if applicable) must be met within 30 days of the close of the 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. Financial disclosure statement may be required.   

5. One-year probationary period may be required. 

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

7. Bargaining Unit Position: Yes  

8. Drug Screening Required:  No 

9. Recruitment incentives may be authorized: No 

10. Student loan repayment incentive authorized: No 

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

 

 

HOW YOU WILL BE EVALUATED:

Once the application process is complete, a review of the best-qualified applications will be conducted.  The résumé and supporting documentation will be compared against the applicant's responses to the assessment questionnaire to determine if the applicant is qualified for this job. If, after reviewing the applicant's résumé and supporting documentation, a determination is made that the applicant has inflated his/her qualifications and/or experience, the applicant may lose consideration for this position and/or the applicant's score may be adjusted to more accurately reflect his/her skills and abilities.  Please follow all instructions carefully. Errors or omissions may affect your eligibility.

 

For Competitive Applicants/All U.S. Citizens:  Eligible candidates will be assigned to a quality category: Best Qualified, Well Qualified or Qualified.  Candidates in the highest category will be referred to the hiring agency. The Category Rating process does not add veterans' 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-09 level or higher.) 

  • Technical Knowledge - Medical Device/Scientific System Review
  • Problem Solving
  • Written Communication
  • Oral Communication


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 see http://www.fedshirevets.gov/ .

Career Transition Assistance Programs: 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'.  For information on how to apply and what documents to submit as an CTAP/ICTAP eligible, go to: http://www.opm.gov/rif/employee_guides/career_transition.asp#ictap.  Candidates must meet or exceed the Well-Qualified category (85) to be considered as a CTAP/ICTAP eligible.

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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The complete Application Package must be submitted by 11:59 PM (EST) on Friday, January 03, 2014

 

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 select your USAJobs resume and/or other supporting documents and complete the assessment questionnaire. Please ensure you click the Submit My Answers button at the end of the process.

 

To verify your application is complete, log into your USAJobs account (https://my.usajobs.gov/Account/Login) and select the Application Status link.  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 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 fax supporting documents you are unable to upload, complete this cover page http://staffing.opm.gov/pdf/usascover.pdf using the following Vacancy ID: 1016487.   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



REQUIRED DOCUMENTS:

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

1. Your Résumé:  Resumes should include full description of job duties as well as dates (mm/yr) of employment
2. A complete Assessment Questionnaire
3. Other supporting documents:
         - Veterans Preference Documentation, if applicable 
         - College transcript(s)
          

          - CTAP/ICTAP documentation, if applicable 

    

AGENCY CONTACT INFO:

Philadelphia Services Branch
Phone: (215)861-3074
Email: PHILADELPHIA@OPM.GOV
Agency Information:
HHS OPM
US Office of Personnel Management
600 Arch Street
Philadelphia, PA
19106
USA

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-CDRH-DE-14-1016487

Control Number:

357719200