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

Job Title:Patient Product Information Specialist

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-CDER-MP-13-897931

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, June 21, 2013 to Friday, August 02, 2013

SERIES & GRADE:

GS-0601-12/13

POSITION INFORMATION:

Full Time - Permanent

PROMOTION POTENTIAL:

13

DUTY LOCATIONS:

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

WHO MAY APPLY:

Government Wide Status Candidates

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 Food and Drug Administration (FDA), Center for Drug Evaluations and Research (CDER), Office of Medical Policy (OMP), in Silver Spring Maryland. 

 

KEY REQUIREMENTS

  • YOU MUST SUBMIT YOUR MOST RECENT SF-50 .
  • Must be a government employee in status.

DUTIES:

Back to top

  • Patient product information may consist of Medication Guides, which are subject to FDA regulation, patient package inserts, which are voluntary and maybe included as part of product labeling;
  • Responsible for making recommendation to ensure that risks and indications are adequately communicated to patients;
  • Compare the patient labeling to the professional labeling to ensure consistency in content and that FDA requirements are consistent and equitably applied to all patient labeling and related materials;
  • Must be concise, easily  evaluated, and utilize knowledge of the drug review and drug labeling requirements;
  • Work with senior staff to review special and unusual problems submitted by various Centers and provide authoritative guidance and conduct research into legal precedent and legislative history of the Acts enforced by FDA;
  • Act as liaison between the Office and other agency units, includes review divisions and participates in negotiation with firms as appropriate;
  • Initiate communication (oral and written) regarding FDA regulatory  decisions, policy matters, or request for information from regulated industries;
  • Participate at meetings of major groups (such as industry, federal government, professional associations and consumer groups) to share policies and best practices; and
  • Negotiate the timely resolution of scientific and regulatory conflicts or problems to avoid delays in achieving goals.

 

 

 


QUALIFICATIONS REQUIRED:

Back to top

 

For GS-12 Grade Level:

Must have one year of experience equivalent to the  GS-11 grade level in Federal service.

For GS-13 Grade Level:

Must have one year of experience equivalent to the GS-12 grade level in Federal service.

Please refer to : http://www.opm.gov/qualifications/Standards/group-stds/gs-prof.asp

 


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: Yes

 

9. Drug Screening Required:No

 

10. Recruitment incentives may be authorized:No

 

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

 

12. Student loan repayment incentive authorized:No

 

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

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 on the following competencies (knowledge, skills, abilities and other characteristics):

 

Knowledge of FDA regulations, legislation, and administrative procedures.

Ability to communicate ideas and concepts on the use of drugs to consumers.

Skill in working with others to maximize each person's contribution and produce, excellent results.

Knowledge of the laws and regulations and of effective written communication techniques.


BENEFITS:

Back to top

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):  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:

Back to top

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 897931.  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 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.


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

- Submit SF-50, (including the highest grade held), if applicable

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

 

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 02, 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).


Back to top
Dock
Print Preview

Job Announcement Number:

HHS-FDA-CDER-MP-13-897931

Control Number:

345846100