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

Job Title:Supervisory Medical Officer, GS-602-15

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-CDER-MP-13-975745

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

The contents of the announcement can still be viewed.

SALARY RANGE:

$123,758.00 to $155,500.00 / Per Year

OPEN PERIOD:

Friday, October 11, 2013 to Friday, October 18, 2013

SERIES & GRADE:

GP-0602-15

POSITION INFORMATION:

Full Time - Permanent

PROMOTION POTENTIAL:

15

DUTY LOCATIONS:

1 vacancy in the following location:
Rockville, MD United StatesView Map

WHO MAY APPLY:

Current Center for Drug Evaluations and Research Employees Only*

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 Supervisory Medical Officer within the Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), you will serve as the Division Director in planning, managing, coordinating, and evaluating the clinical review and safety/surveillance activities of the Division.  

 

*This announcement is open to current CDER employees serving in a career or career-conditional appointment.

 

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
  • All supporting documents must be received by the closing date

DUTIES:

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  • Provides technical expertise on clinical issues related to generic drug products.
  • Conducts bioequivalence studies with clinical endpoints, safety assessments during bioequivalence trials and surveillance of safety aspects of currently approved generic products.
  • Conducts secondary review and evaluations of abbreviated new drug applications (ANDAS), consultations, study protocols, and controlled correspondences.
  • Provides leadership and direction in strengthening the clinical review component that defines the safety of generic drug products during the pre- and post-approval process.
  • Collaborates in interdisciplinary team settings to discuss issues related to products under review and to provide authoritative advice on difficult or high priority decisions.


QUALIFICATIONS REQUIRED:

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In order to be qualified for this position, you must possess the following:

  • DEGREE:  Doctor of Medicine or Doctor of Osteopathy from a school in the United States or Canada approved by a recognized accrediting body in the year of the applicant's graduation  OR  a Doctor of Medicine or equivalent degree from a foreign medical school that provided education and medical knowledge substantially equivalent to accredited schools in the United States.   (Such equivalency is demonstrated by permanent certification by the Educational Commission for Foreign Medical Graduates (ECFMG) (or a fifth pathway certificate for Americans who completed premedical education in the United States and graduate education in a foreign country). - AND -
  • GRADUATE TRAINING:  At least one year of supervised experience completed during a graduate training program.  These include only those internship, residency, and fellowship programs that are approved by accrediting bodies recognized within the United States or Canada. Listings of accredited programs are published yearly in the Directory of Residency Training Programs and the Yearbook and Directory of Osteopathic Physicians. - AND -
  • LICENSURE: Possess a permanent, full, and unrestricted license to practice medicine in a State, District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States. - AND -

EXPERIENCE:  One year of specialized experience, equivalent to the GS-14 level in the Federal service, providing leadership and direction to a professional staff in the clinical review of generic drug products as it relates to safety, efficacy, and/or bioequivalence.


You must submit an official transcript, unofficial transcript, which states 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.

 

Education must be accredited by an accredited institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications (particularly positions with a positive education requirement.)  Therefore, applicants must report only attendance and/or degrees from schools accredited by accredited institutions recognized by the U.S. Department of Education.  Applicants can verify accreditation at the following website:  http://www.ed.gov/admins/finaid/accred/index.html 

 

*** If you are using foreign education to meet qualification requirements, you must submit a Certificate of Foreign Equivalence with your transcript in order to receive credit for that education.***

 

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; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit: http://www.ed.gov/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html 

 

 

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

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. 

  • Optional Form 306 – Declaration of Federal Employment – available at http://www.opm.gov/forms/pdf_fill/of306.pdf. This form is not required to be submitted at the time of submitting your application. However, if selected, this form will be required prior to final job offer.  

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 within 30 days after the closing date of the announcement.   

6. Financial disclosure statement maybe required

7. One-year probationary period may be required. 

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

9. Bargaining Unit Position:  No

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

14.  Travel away from duty station required:  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 CDER Merit Promotion Applicants:  The highest rated candidates will be referred to the hiring agency.

For Noncompetitive CDER 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:

  • Clinical Evaluation and Practices
  • Leadership
  • 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:

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

 

Note: To return to your saved application materials, log in at: https://applicationmanager.gov/ and click on 975745.

 

If you cannot apply online, you will need to:

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.

4) Print the Fax Cover Page and include with any supporting documents you fax (e.g., résumé, transcripts, veterans documentation, etc.) to the same fax number above.

 

Please do not complete steps 1-4 above if you are applying on-line.



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 - demonstrating that you are a career or career-conditional employee of CDER
  • College transcript(s)
  • License to Practice Medicine

 

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-13-975745

Control Number:

353181800