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

Job Title:Health Scientist Administrator (Regulatory Specialist) - NHLBI - MP

Department:Department Of Health And Human Services

Agency:National Institutes of Health

Job Announcement Number:NIH-NHLBI-MP-12-598000

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 $136,771.00 / Per Year

OPEN PERIOD:

Friday, April 6, 2012 to Sunday, April 15, 2012

SERIES & GRADE:

GS-0601-12/14

POSITION INFORMATION:

Full Time - Permanent

PROMOTION POTENTIAL:

14

DUTY LOCATIONS:

1 vacancy - Montgomery County, MD United StatesView Map

WHO MAY APPLY:

Status Candidates (Merit Promotion and VEOA Eligibles)

JOB SUMMARY:

The NIH is the premier biomedical research center for the world.  Its 27 Institutes and Centers employ approximately 18,000 employees doing a vast array of jobs, all supporting efforts for a healthy nation. For information on the NIH mission, goals, and Institutes and Centers, visit NIH Overview .

The Office of Translational Alliances and Coordination (OTAC) in the Division of Extramural Research Activities (DERA), National Heart, Lung, and Blood Institute (NHLBI) is seeking outstanding candidates for the Health Scientist Administrator Regulatory Specialist position.

The OTAC is charged with accelerating the translation of basic discoveries and innovations into new diagnostics, devices, and therapeutics, and facilitating the development of new technologies via Small Business Innovation Research (SBIR) initiatives. The Office facilitates identification of emerging areas of translational opportunities and provides functional integration by developing interdependent teams that leverage resources and intellect across the NHLBI, and with other NIH Institutes, agencies, and organizations. The OTAC enhances communication and coordination between existing programs, develops and coordinates strategic initiatives and Funding Opportunity Announcements (FOAs), and identifies and capitalizes on synergies to meet and enhance program goals.

KEY REQUIREMENTS

  • Time in grade met within 30 days of closing date.
  • Position is subject to a background investigation.
  • Education requirement - transcripts are required.
  • Travel required.

DUTIES:

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The Regulatory Specialist will serve as the Institute's regulatory (knowledge of FDA regulatory requirements) expert on matters related to new translational technology development and commercialization of advanced technology platforms for research, diagnosis, treatment, control and prevention of cardiovascular, lung and blood diseases; serve as a resource to the OTAC Director and other senior leadership within the Institute and across NIH, providing advice in the planning, development and implementation of policy and programs as they affect a broad range of stakeholders; provide technical expertise on scientific research as it relates to intellectual property and collaborative agreements; manage milestone driven research; provide daily technical oversight and coordination of technology development projects and projects related to post-marketing safety initiatives. 

Although not required, the ideal candidate will have experience applying FDA regulatory requirements for technology development.

For additional Information: NHLBI Vacancy Page


QUALIFICATIONS REQUIRED:

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Basic Requirements:

Applicants for all grades must be U.S. Citizens and must meet the requirements described in paragraphs A or B below:

A. Successful completion of all requirements for a Ph.D. (or equivalent doctoral degree), in an accredited college or university, including acceptance of the dissertation, in an academic field of the health or pertinent sciences (i.e. biochemistry, molecular biology, physiology, etc.) Allied to health or health related research;or

B. Successful completion of a full 4-year course of study in an accredited college or university, leading to a bachelor's or higher degree, with major study in an academic field of the health or pertinent sciences which have been applied and utilized by the applicant in health or health-related research and, in addition, at least 1 year of qualifying progressively responsible experience; or any equivalent combination of graduate study and research experience in these fields. This education and experience must demonstrate that the applicant has acquired the scientific knowledge, skills and abilities to apply and utilize them successfully in health or health-related research at a level which is the qualitative equivalent of that acquired in meeting all the requirements for the Ph.D. degree (or equivalent doctoral degree), including the dissertation as indicated above. The appropriate doctoral equivalency must be supported by publications in health or health-related research accomplishment in appropriate scientific journals; or other objective evidence in such form that it may be reviewed and evaluated.

Applicants must demonstrate that they have (1) worked independently in planning, organizing, and conducting biomedical behavioral health, or health-related research; (2) served effectively, in research program administration in these fields; and (3) acquired an understanding of the history, interests, internal dynamics, and relationships of organizations in which health research is conducted. This experience may be gained as a principal investigator of a grant or contract, or may otherwise be gained through active involvement in initiating research projects, developing protocols, conducting studies, documenting findings, interpreting results in a published report (journal), supervising staff, and managing the budget.

Your background must show progressively responsible and successful experience (complexity of work in independent research and research program administration), to be eligible for each successively higher grade level. Specific examples of qualifying experience may be found at this link: http://www.jobs.nih.gov/announcement-links/healthadministrator.htm.

GS-12: You must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-11 level in the Federal Government. Examples of qualifying experience include: serving as a principal investigator or equivalent on a grant or contract which was obtained competitively, beyond the doctor degree; health research program administration; and primary authorship on peer-reviewed research publications, internal research reports or patents.

GS-13: You must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-12 level in the Federal Government. Examples of qualifying experience include: reviewing the technical and scientific merit of applications and proposals received requesting grant or contract funds; providing advice in program planning, solicitation, and evaluation to perform day-to-day administrative functions related to research grants or interagency agreements supporting research projects in your scientific area; identifying new basic, translational and clinical research concepts, projects and initiatives to appropriate advisory groups and formulate and develop Program Announcements, RFAs, RFPs, or a combination of these, to achieve objectives.

GS-14: You must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-13 level in the Federal Government. Examples of qualifying experience include: organizing and conducting workshops, conferences, symposia or similar activities to foster the aims of the program, to facilitate communication among investigators, or to advise on the status of progress and emerging directions of research in the assigned program area; managing the initial scientific and administrative review of center grant, program project grant, or training grant applications, as well as research project applications submitted in response to requests for applications, multicenter clinical trial applications, and contract proposals assigned to the program area; planning, advising, and evaluating program activities for a portfolio of research project, research program and other grants/awards, cooperative agreements, or contracts in the assigned program area and the discovery, development and evaluation of associated prevention and therapeutic strategies; reviewing and evaluating periodic and interim progress reports to determine effectiveness of support and achievement of objectives; recommending funding plans for initiatives; establishing the criteria and standards for a review panel.

View Assessment Questions


This position has an education requirement. You must submit a copy of your transcripts (or a list of your courses including titles, credit hours completed and grades). Unofficial transcripts will be accepted in the application package; however, official transcripts will be required prior to receiving an official offer.  Click here for information on Foreign Education .  If you are currently or were previously in this occupation series you do not need to submit transcripts. Instead, submit an SF-50 showing the appointment in this occupational series.

Males born after December 31, 1959 must be registered with Selective Service.

HOW YOU WILL BE EVALUATED:

Evaluation Method


BENEFITS:

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The federal government offers a comprehensive benefits package including vacation, sick leave, holidays, life insurance, health benefits, and participation in the Federal Employees Retirement System.  For more information, check out New Employee Benefits at NIH and OPM's Employee Benefits Information.

OTHER INFORMATION:

PHS Commissioned Officers interested in performing the duties of this position within the Commissioned Corps should also apply online to this announcement in order to receive consideration.

We are unable to pay relocation expenses.

A one-year probationary period may be required upon selection/ placement.

NIH may repay certain outstanding Federally-insured student loans to facilitate the recruitment and retention of highly qualified people. Recipients will be determined on a case-by-case basis based on organizational need, specific case justification, and budget limitations.

A newly appointed or reappointed employee may receive service credit for prior work experience or active duty uniformed service that otherwise would not be creditable for the purpose of determining his or her annual leave accrual rate. All creditable service must be directly related to the duties of the position being filled and decisions to allow for such credit must be finalized prior to the selectee's entrance on duty. The use of this service credit incentive is at the discretion of the selecting official and service credit is granted only for a position deemed hard-to-fill.

This position requires overnight travel that might be up to 3 nights per year.

Additional selections may be made through this vacancy announcement.  The National Institutes of Health participates in the USCIS Electronic Employment Eligibility Verification Program ( E-Verify ).  E-Verify helps employers determine employment eligibility of new hires and the validity of their Social Security numbers.  The NIH maintains a tobacco free work environment and campus .



HOW TO APPLY:

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Submission of a resume alone IS NOT a complete application.   You must provide a complete online Application Package which includes:

  • Your Resume (Please provide sufficient details in your resume to enable us to determine if you meet the requirement for qualifying experience (as stated in the Qualifications section) and to support your answers to the online questionnaire.   Providing insufficient details in your resume may result in a lower or ineligible rating.)  
  • A complete Assessment Questionnaire, View Assessment Questions.
  • Other required supporting documents (See the Required Documents section for any additional forms and/or supplemental materials required.)
  • If you would prefer to submit a Curriculum Vitae (CV) for consideration, you may submit a skeletal online resume and Fax your CV.   Submission of a resume/CV alone IS NOT a complete application.   You must complete the online questionnaire that will appear when you begin your application on USAJOBS.   (See the Required Documents section for any additional forms and/or supplemental materials required.)

To begin the online application process, click the "Apply Online" button at the bottom of this screen to log in to your existing USAJOBS account or to create an account if you do not already have one.

  • Follow the prompts to complete the Assessment Questionnaire. Please ensure you click the "Submit My Answers" button at the end of the process.
  • To fax supporting documents you are unable to upload, you must use the fax coversheet found at http://staffing.opm.gov/pdf/usascover.pdf .    Include the vacancy announcement number for the job to which you are applying, 598000.   Fax your documents to 1-478-757-3144.

If you have questions or require reasonable accommodation during the application process,  please contact the HR staff member listed below.   If you cannot apply online, these are the steps to follow:

  1. Click the following link to view and print the assessment questionnaire View Occupational Questionnaire, View Occupational Questionnaire.
  2. Print this 1203-FX form to provide your response to the occupational questionnaire http://www.opm.gov/forms/pdf_fill/OPM1203fx.pdf.
  3. In Section 25 of the Occupational Questionnaire, you may notice that the numbering restarts with number one. When entering your responses on the 1203-FX form please continue to enter your responses on the next available number within this section. The numbers on the 1203-FX will not match the Occupational Questionnaire once it restarts with number one. This issue has been identified and will be resolved as soon as possible.
  4. Fax the completed 1203-FX form along with any supporting documents to 1-478-757-3144. Your 1203-FX will serve as a cover page for your fax transmission.

If you have difficulties with hearing and are seeking assistance, please call a relay operator at 1-800-735-2258 or visit Maryland Relay or AT&T Relay.

For technical difficulties, contact HR Systems Support between 8 AM and 4:30 PM ET Monday through Friday at 301-451-1436 or hrsystemssupport@mail.nih.gov.

Additional Information on How to Apply

Information on Reasonable Accommodation

To check the status of your application or return to a previous or incomplete application, log into your USAJOBS account, select "My Applications", and click on the "more information" link under the application status for this position.



REQUIRED DOCUMENTS:

The following information must be received by 11:59pm on the closing date of the announcement, Sunday, April 15, 2012.  

  1. Resume via USAJOBS.
  2. Responses to online questionnaire.
  3. If applicable, supporting documentation (including DD214 to support Veterans' Employment, CTAP/ICTAP, Schedule A, or other information requested in the announcement such as transcripts). To ensure your information is secure, please block out any Social Security numbers (SSNs). Clean copies may be requested if you are hired.
  4. If submitting a copy of your Notification of Personnel Action (SF-50), or equivalent, submit one that shows the effective date of your current position and the full performance level. You may obtain a copy of your SF-50 from your HR Office or, if you are an HHS employee, from eOPF. If you have separated from Federal Government employment, you may obtain a copy of your SF-50 via: Federal Records Center, National Archives and Records Administration, 111 Winnebago Street, St. Louis, MO 63118-4126 or Email CPR, or visit the National Archives Website.

AGENCY CONTACT INFO:

David Wittenberg
Phone: (301)435-3416
Email: WITTENBERGD@MAIL.NIH.GOV
Agency Information:
National Institutes of Health
2115 E Jefferson St
Bethesda, MD
20892

WHAT TO EXPECT NEXT:

Within 15 business days of the closing date, Sunday, April 15, 2012, you may check your status online at USAJOBS We will update your status after each key stage in the application process has been completed.

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Job Announcement Number:

NIH-NHLBI-MP-12-598000

Control Number:

311245000