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

Job Title:Lead Regulatory Health Project Manager

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-CDER-MP-13-912274

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, June 21, 2013 to Tuesday, July 09, 2013

SERIES & GRADE:

GS-0601-14

POSITION INFORMATION:

Full Time - Permanent

PROMOTION POTENTIAL:

14

DUTY LOCATIONS:

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

WHO MAY APPLY:

CENTER FOR DRUG EVALUATION AND RESEARCH STATUS CANDIDATES 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:  Federal employees with career or career-conditional appointments in the competitive service; former Federal employees with reinstatement eligibility based on previous career or career-conditional appointments;  

 

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

 

 

KEY REQUIREMENTS

  • You must submit a current copy of your SF-50

DUTIES:

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The incumbent of this position serves as a Lead Regulatory Health Project Manager within the Division;

 

Must be able to represent the Directors in policy development matters considered by the Division.

Expert in project coordination and regulations pertaining to medical policy development to be able to apply imaginatively the principles of project management in a complex and fluid environment.

Provide substantive recommendations in the planning and developing of overall policies and objectives. 

Participate fully in formal and informal policy and planning conferences as directed by the Directors.

Represent the Division, Office, Center and FDA on committees, making commitment, suggestions and recommendations concerning policies within his/her area of responsibility, independently assembles data and prepares answers to reports requested by the Commissioner, Congress, and other group within and outside the Agency as required.

Communicate to the team the assignments, projects and/or program issues within the responsibility of the division, as well as the associated deadlines and timeframes for completion.

Review and finalize material that require a rapid, quick-turnaround response for the Office.

Team Leader Responsibilities:

 

    Director group operations through regulatory and technical personnel.

 

    Works closely with medical and other scientific reviewers in the Center on sensitive programmatic matters, and advises the Director/Deputy Division Director and other managers on matters within the group's area of functional responsibility.

    Assures consistency and equity of work performance standards and rating techniques for the area supervised.

    Makes decisions on work problems presented by subordinates.

    Evaluates the performance of subordinates

    Is the recommending official for group positions.

    Hears and resolves group grievances or serious employee complaints.

    Recommends serious disciplinary actions (e.g., suspensions) involving subordinate personnel.

    Recommends awards or bonuses for group personnel and changes in position  classifications, subject to higher level approval.

    Identifies staff training needs, interviews and makes recommendations on applicants for position vacancies within the group, and recommends personnel actions.

    Finds and implements ways to eliminate or reduce significant bottlenecks and barriers to work processes in the group and promotes team building.

 

 

 

 

 

 

 

 

 


QUALIFICATIONS REQUIRED:

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Specialized Experience (All positions except Reporting Stenographer, Shorthand Reporter, and Closed Micro-phone Reporter)--Experience that equipped the applicant with the particular knowledge, skills, and abilities (KSA's) to perform successfully the duties of the position, and that is typically in or related to the position to be filled. To be creditable, specialized experience must have been equivalent to at least the next lower grade level. Applicants who have the 1 year of appropriate specialized experience, as indicated in the table, are not required by this standard to have general experience, education above the high school level, or any additional specialized experience to meet the minimum qualification requirements.


 

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: No

 

8. Bargaining Unit Position: No

 

9. Drug Screening Required: 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.  Merit Promotion Procedures for the Food and Drug Administration (FDA) procedures will be used to rate and rank candidates.  The category assignment is a measure of the degree in which your background matches the competencies required for this position.  Qualified candidates will be ranked into one of two categories:  Best Qualified or Qualified.
 

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

 

Ability to oversee the day to day management of drug application reviews.

Knowledge of the Food, Drug, and Cosmetic Act and related regulations and laws.

 

Ability to communicate orally.

 

Ability to communicate 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:

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

 

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) or Career transition Assistance Program (CTAP): 

For information on how to apply as an ICTAP/CTAP 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 apply for this position, you must complete the occupational questionnaire and submit the documentation specified in the Required Documents section below.

The complete application package must be submitted by 11:59 PM (EST) on Tuesday, July 09, 2013 to receive consideration.

  • To begin, click Apply Online to create a USAJOBS account or log in to your existing account. Follow the prompts to select your USAJOBS resume and/or other supporting documents and complete the occupational questionnaire.
  • Click the Submit My Answers button to submit your application package.
  • It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date. 
  • To verify your application is complete, log into your USAJOBS account, https://my.usajobs.gov/Account/Login, select the Application Status link and 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.


REQUIRED DOCUMENTS:

All applicants are required to submit the following supporting document type(s):
   ·SF-50
   ·Transcript

Applicants may also submit the following supporting document type(s),which may not be required for all applicants:
   ·Resume


Faxing Applications or Supporting Documents:

You are encouraged to apply online.  Applying online will allow you to review and track the status of your application.

NOTE:  If you applied online and your application is complete, do not fax the paper application (1203FX) as this will overwrite your prior online responses and may result in you being found ineligible.

If you completed the occupational questionnaire online and are unable to upload supporting document(s):

1. To fax your documents, you must use the following cover page http://staffing.opm.gov/pdf/usascover.pdf and provide the required information.  The Vacancy ID is TAG:912274.

2. Fax your documents to 1-478-757-3144.

If you cannot complete the Application Package online, you may fax all of your materials.  The complete application package must be submitted by 11:59 PM (EST) on TAG:Tuesday, July 09, 2013  to receive consideration.  Keep a copy of your fax confirmation in the event verification is needed.

To complete the occupational questionnaire and submit via fax:

1. Click the following link to view and print the occupational questionnaire View Occupational Questionnaire.

2. Print the 1203FX form, follow the instructions and provide your responses to the occupational questionnaire items http://www.opm.gov/forms/pdfimage/opm1203fx.pdf

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 Customer HelpDesk at (888) 478-4340; TTY/TDD: (800) 877-8339; or by email quickquestions@psc.gov.  The decision on granting reasonable accommodation will be made on a case-by-case basis.

For Résumé and Application Tips visit: https://help.usajobs.gov/index.php/Tips.

AGENCY CONTACT INFO:

FDA Helpdesk
Phone: (888)478-4340
Fax: (478)757-3144
Email: QUICKQUESTIONS@PSC.GOV
Agency Information:
HHS FDA Center
10903 New Hampshire Avenue
Silver Spring, MD
20993 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-CDER-MP-13-912274

Control Number:

345946400