| $124,995.00 to $157,100.00 / Per Year |
OPEN PERIOD: | Monday, October 27, 2014 to Monday, November 10, 2014 |
SERIES & GRADE: | GS-0301-15 |
POSITION INFORMATION: | Full Time - Permanent |
PROMOTION POTENTIAL:15 | |
DUTY LOCATIONS: | 1 vacancy in the following location: Silver Spring, MD View Map |
WHO MAY APPLY: | United States Citizens |
SECURITY CLEARANCE: | Q - Nonsensitive |
SUPERVISORY STATUS: | No |
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 Department of Health and Human Services (HHS), Food & Drug Administration (FDA), Office of the Commissioner (OC), Office of Medical Products and Tobacco (OMPT), Office of Special Medical Programs (OSMP) in Silver Spring, Maryland.
Who May Apply: Open to all United States Citizens.
Additional selections may be made within the same geographical area FDA-wide.
TRAVEL REQUIRED
- Occasional Travel
- 2 % Travel (Domestic)
RELOCATION AUTHORIZED
- No
KEY REQUIREMENTS
- U.S. Citizenship is required.
- Only experience gained by closing date of announcement will be considered.
- One year probationary period may be required.
DUTIES:
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The Regulatory Counsel serves as the Deputy Director for Regulatory Policy in the Immediate Office (IO), Office of the Commissioner (OC), Office of Special Medical Programs (OSMP), and as an expert and authority in regulatory policy on issues that potentially have a profound impact on the agency's advisory committee program, combination products programs, orphan products programs, pediatric therapeutics programs, and good clinical practice programs, as well as other assigned policy topics.
If selected for this position, you will:
Perform duties that include resolving a broad range of issues concerning the application of any of the Food & Drug Administration's (FDA) enabling legislation or pertinent regulations;
Provide regulatory expertise to the Office of Special Medical Programs (OSMP) and staff;
Serve as chief policy overseer and/or editor in drafting all OSMP policy, guidance and regulatory documents including policy initiatives, and comments and reports to the Department of Health and Human Services, the General Services Administration, and White House, or Congress;
Serve as a recognized expert in regulatory matters related to the OSMP core programs;
Evaluate conflict of interest determinations for agency advisory committee members, and make recommendations to the Associate Commissioner for Special Medical Programs regarding waivers, appearance authorizations, and other regulatory decisions; and
Lead the development of OSMP guidance, regulations and policy documents that impact the Agency and public health.
QUALIFICATIONS REQUIRED:
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MINIMUM QUALIFICATION
Specialized Experience is 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. You must have one (1) year of specialized experience equivalent to the GS-14 grade level in the Federal service which includes applying the principles, theories, and practices of regulatory processes including expert knowledge of the drug, medical device, biologic, and combination product laws and regulations; independently negotiating at the highest senior level of the organization on complex and sensitive regulatory, legislative, and technical matters which affect regulatory policy issues, and evaluating and integrating perspectives from various organizational components in order to most accurately and effectively advise senior leaders on public health regulatory policy.
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. Pre-employment physical required: No
5. Drug testing required: No
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. Pre-employment physical required: No
5. Drug testing required: No
6. License required: No
7. Mobility agreement required: No
7. Mobility agreement required: No
8. Moving expenses authorized: No
9. Immunization required: No
10. Relocation Incentive authorized: No
11. Recruitment Incentive authorized: No
12. Student loan repayment incentive authorized: Yes
13. Annual leave for non-federal service authorized: No
14. Bargaining Unit Position: Yes
9. Immunization required: No
10. Relocation Incentive authorized: No
11. Recruitment Incentive authorized: No
12. Student loan repayment incentive authorized: Yes
13. Annual leave for non-federal service authorized: No
14. Bargaining Unit Position: Yes
15. Please be advised that this position will be subject to FDA’s strict prohibited financial interest regulation and therefore, may require the incumbent of this position to divest of certain financial interests. Applicants are strongly advised to seek additional information on this requirement from the FDA hiring official before accepting this position.
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 resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible or 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.
Basis of Rating: Category rating 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 assigned to one of the following quality categories: Best Qualified, Well Qualified or Qualified.
Best Qualified – Applicants who have experience that is almost identical to those required by the position, including any quality ranking factors identified.
Well Qualified – Applicants who have experience that is very similar to those required by the position.
Qualified – Applicants who meet minimum qualification requirements, but do not identify any additional qualifying experience or skill.
The Category Rating Process does not add veterans’ preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 10 percent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher).
Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You do not have to respond to the KSA’s separately, but your resume should contain sufficient information to demonstrate possession of the Competencies/KSA’s.
1. Knowledge of the Food, Drug & Cosmetic Act related to medical devices, biologics, and drug products.
2. Ability to evaluate and analyze facts and legal information to formulate conclusions.
3. Ability to foster cooperative working relationships with diverse scientists, medical and regulatory professionals.
4. Skill in written communication.
5. Skill in oral communication.
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 (Member 4 copy) 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
Career Transition Program: This program applies to Federal workers whose positions have been deemed “surplus” or no longer needed, or an employee who 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 an ICTAP eligible, see: http://www.opm.gov/rif/employee_guides/career_transition.asp
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 Monday, November 10, 2014to 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 are 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, https://my.usajobs.gov/Account/Login 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.
- 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.
REQUIRED DOCUMENTS:
All applicants are required to submit the following supporting document type(s):
·Resume
Applicants may also submit the following supporting document type(s),which may not be required for all applicants:
·Cover Letter
·DD-214
·Other Veterans Document
·SF-15
·Transcript
Other Supporting Documents: (only submit if applicable)
·Resume
·Cover Letter
·DD-214
·Other Veterans Document
·SF-15
·Transcript
Other Supporting Documents: (only submit if applicable)
- College transcripts (unofficial copy acceptable)
- Veterans’ Preference documentation [e.g., DD-214 which shows type of discharge/character of service (Copy 4), SF-15, VA letter, etc.]
- CTAP/ICTAP documentation
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.pdfand provide the required information. The Vacancy ID is 1229436.
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 Monday, November 10, 2014 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.
AGENCY CONTACT INFO:
FDA Helpdesk
Phone: (888)478-4340
Fax: (478)757-3144
TDD: 800-877-8339
Email: QUICKQUESTIONS@PSC.GOV
Phone: (888)478-4340
Fax: (478)757-3144
TDD: 800-877-8339
Email: QUICKQUESTIONS@PSC.GOV
Agency Information:
HHS FDA Center
10903 New Hampshire Avenue
Silver Spring, MD
20993 Fax: (478)757-3144
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. Once this process is completed, you will be notified of your status via e-mail.