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

Job Title:Senior Clinical Analyst

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-MP-13-938960

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, August 12, 2013 to Friday, August 23, 2013

SERIES & GRADE:

GS-0601-14

POSITION INFORMATION:

Full Time - Permanent

PROMOTION POTENTIAL:

14

DUTY LOCATIONS:

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

WHO MAY APPLY:

Career Conditional/Career employees within the 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.

This position is located in the Center for Drug Evaluation & Reserarch (CDER), Office of New Drugs (OND), Office of Antimicrobial Products (OAP), Divison of Antiviral Products (DAP) located at the White Oak Campus in Silver Spring, MD.

 

Who May Apply:  Current OND employees only, with career or career conditional appointments in the competitive service;  

 

 

YOU MUST SUBMIT YOUR SF-50 (AND DD-214 IF APPLICABLE).

 

This announcement may be used to fill multiple positions in multiple locations.

KEY REQUIREMENTS

  • U.S. Citizenship is required.
  • Must submit most recent SF-50
  • Must provide transcripts.

DUTIES:

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Major Duties:

 

Review and evaluate clinical study protocol and reports submitted in BLA’s, NDA’s, supplemental; new INDs, new protocols and protocol amendments. 

 

Evaluate development plans and study protocols to determine the safety of designs and the ability to generate evidence of effectiveness.

 

Review and evaluate reports of clinical trials to determine if the data are adequate and well controlled, and sufficient to support the efficacy and safety of the drug under investigation.

 

Participate in coordinating initiatives and activities related to the program and the implementation of regulations and guidance.

 

Coordinate with other CDER offices on complex regulatory issues and keeps abreast of crucial and precedent-setting cases within agency.


QUALIFICATIONS REQUIRED:

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I. Basic Requirement:

A. Basic Requirement for GS-601 Senior Clinical Analyst: Degree in a major study in an academic field related to the health sciences or allied sciences appropriate to the work of the position.

Transcripts must be submitted at time of application of submission to support education requirements. 

II. Specialized Experience Requirement:

GS-14: Have one year of specialized experience, equivalent to the GS-13 level in the Federal service, demonstrating use of regulations and procedures involved in the product and drug development and review process; participating in the management and coordination of scientific projects and initiatives as well as planning, focusing and coordinating of the teams’ activities.

 

Minimum Qualifications:

In addition to the basic requirements applicants must have one year of specialized experience at the next lower grade in the Federal Service.  Specialized experience at the GS-13 level in the Federal Service are as follows:  providing authoriative advice and guidance on all aspects of prescription drug product labeling review and approval. Reviewing USPI to help ensure it conforms to labeling regulations, assisting in facilitation of labeling meetings, and monitoring development of labeling New Drug Applications.


 

Conditions of Employment:

 

1. Additional Security and Background Requirements:  May be referred depending on the position being filled.  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. All qualification requirements must be met by the closing date of the announcement.

 

3. Financial disclosure statement may be required.

 

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

 

5. Bargaining Unit Position: Yes 

 

6. Drug Screening Required: No

 

7. Recruitment Bonus may be authorized: No

 

8. Research position: No

 

9. Supervisory position: No

 

10. Time in grade (TIG) must be met within 30 days of the closing date of the announcement.

HOW YOU WILL BE EVALUATED:

Once the application process is complete, a review of the 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 and rated on the following competencies (knowledge, skills, abilities and other characteristics):

 

 

1. Knowledge of scientific, clinical, and medical regulations pertinent to program.

 

2. Ability to communicate orally.

 

3. Abiltiy to communicate in writing.


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/ResourceCenter/Index/Interactive/Benefits#icc.



OTHER INFORMATION:

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.

 

Career Transition Assistance Program (CTAP):  For information on how to apply as a CTAP eligible see http://opm.gov/rif/employee_guides/career_transition.asp#ctap.  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 938960.  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 Bethesda Center HelpDesk Telephone (888)-478-4340; TTY/TDD: (866)-539-4484; or by email quickquestions@psc.gov.  The decision on granting reasonable accommodation will be made on a case-by-case basis.


REQUIRED DOCUMENTS:

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

  1. 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.

  2. A complete Assessment Questionnaire

  3. Other supporting documents:

  4.      - SF-50 (if you are a federal employee or have reinstatement rights as a federal employee)

         - PHS Commissioned Corps Officer must submit a copy of latest personnel order

         - College Transcripts (if the position has a positive education requirement)

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.

 

For Résumé and Application Tips visit: http://www.usajobs.gov/ResourceCenter/Index/Interactive/ResumeAndApplicationTips#icc.

 

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 OHR
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-13-938960

Control Number:

349056200