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This Position Closed on 18-Apr-2013

Job Title:Supervisory Clinicial Analyst

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-MP-11-466662

SALARY RANGE:

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

OPEN PERIOD:

Wednesday, April 18, 2012 to Thursday, April 18, 2013

SERIES & GRADE:

GS-0601-15

POSITION INFORMATION:

Full Time - Career/Career Conditional

PROMOTION POTENTIAL:

15

DUTY LOCATIONS:

1 vacancy(s) - Silver Spring, MDView Map

WHO MAY BE CONSIDERED:

OND-Wide Status 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.

 

Who May Apply: FDA/OND Federal employees only with career or career-conditional appointments in the competitive service;  YOU MUST SUBMIT YOUR SF-50 AND/OR DD FORM 214.

    KEY REQUIREMENTS


  • US Citizenship Required

DUTIES:

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This position is located in the Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Drug Evaluation II, Silver Spring, Maryland.

The incumbent serves as a full Deputy to the Division Director, and as such may be delegated to the complete range of authoriest as those of the Division Director;

 

Provides oversight, coordination and technical medical expertise and consultative services on the post marketing safety activities typically inovolving the broadest and most controversial, senstitive, and complex subjects;

 

Provides post marketing safety related medical expertise and consultative assistance to the Medical Officer Team Leader(s) and Medical Officers, as well as inter-disciplinary scientific staff members in addressing individual postmarketing safety concerns for individual products, as well as collectively across multiple products in the division and in collaboration with other OND divisions;

 

Oversees the Division's management, tracking, and coordination of postmarketing safety activities, and in coordination with the Division Director and Team Leaders, as well as with other CDER office components, works with review and project management staff to develop and implement timelines for related work completion;

 

Directs and provides leadership on all activitiess related to the planning, development, administration, execution and coordination for postmarketing safety for the respective Division;

 

Serves as a liaision to external entities such as industry, professional organizations, academia, other regulatory agencies, and the public in gathering of information to guide plans for the devleopment of the postmarketing studies, especially those inteded to address safety;

 

Drafts responses to Congressional inquires concerning such issues related to the postmarketing safety initiative;

 

Knowledge of the literature and current clincial and research data and activities relating to assigned drug group(s).

 

 


QUALIFICATIONS REQUIRED:

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**Supervisory probationary period may be required**

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 in an academic field related to the health sciences or allied sciences appropriate to the work of the position.

In addition, applicants must possess one (1) year of specialized experience equivalent to the next lower grade level in the Federal service.   Specialized experience would include providing oversight, coordination and technical medical expertise and consultative services on the post market safety activities typically involving the boradest and most controversial, sensitive, and complex subjects. 

Specialized Experience: Experience that equipped the applicant with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled. To be creditable, specialized experience must have been equivalent to at least the next lower grade level in the normal line of progression for the occupation in the organization.


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/.

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 may be required.

6. One-year probationary period may be required.

7. Travel, transportation, and relocation expenses will be paid.

8. Bargaining Unit Position: No

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):

Knowledge of Post-marketing activities and procedures;

Ability to communicate orally;

Ability to communicate in writing;

Ability to plan and direct the work of a team of professionals.


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 466662.  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/pdfimage/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 Operations Division 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 Thursday, April 18, 2013.

AGENCY CONTACT INFO:

Bethesda Center Helpdesk
Phone: (888)478-4340
Fax: (478)757-3144
Email: QUICKQUESTIONS@PSC.GOV
Agency Information:
OHR Bethesda Operations Center
7700 Wisconsin Ave
Bethesda, MD
20814 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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