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Job Title: Health Science Specialist (Senior Regulatory Affairs Officer)
Company Name: Veterans Affairs, Veterans Health Administration
Location: Washington DC, DC
Position Type: Full Time
Post Date: 02/08/2018
Expire Date: 04/09/2018
Job Categories: Agriculture, Forestry, & Fishing, Consulting Services, Finance/Economics, Government and Policy, Healthcare, Practitioner and Technician, Human Resources, Law Enforcement, and Security, Military, Research & Development, Medical, Nonprofit and Volunteer Services
Job Description
Health Science Specialist (Senior Regulatory Affairs Officer)

This position is located within the Office of Research and Development (ORD), Veterans Health Administration Central Office. ORD consists of four services: Biomedical Laboratory Research and Development, Clinical Service Research and Development, Health Service Research and Development, and Rehabilitation Research and Development. ORD also supports the Technology Transfer Program (TTP) and the Program for Research Integrity Development and Education (PRIDE). The incumbent will serve as the Senior Regulatory Affairs Officer. Duties include, but are not limited to:

  • Serving as the primary ORD executive for laboratory research safety and security programs.
  • Developing and evaluating policy and implementation of laboratory research safety and security requirements and programs.
  • Consulting regularly with stakeholders and interest groups to respond to major health research compliance and assurance issues.
  • Triaging questions regarding research, regulations, and VA policy or the various stakeholders in research and research oversight.
  • Answering consults directly informally or taking them to the regulatory action group in ORD to issue a formal interpretation of research policy that will be communicated in writing, over the signature of the Chief, Research and Development Officer (CRADO) or his/her designee.
  • Developing and implementing on going educational programs for field research personnel including investigators and study staff, facility Research and Development (R&D) office personnel; Institutional Review Board chairs, R&D Committee Chairs, members, and administrators, and other VA facility staff that provide oversight or support to research.
  • Assisting the Director, PRIDE, and other senior-level staff in developing national level policies and guidelines.
  • Supervising regulatory and education staff.
  • Assigning and reviewing work of subordinate staff to ensure compliance with PRIDE, ORD, and VA policies and procedures.
  • Overseeing the development of and approving performance appraisal plans for subordinate staff.
Work schedule: Monday - Friday, 8:00am - 4:30pm
Compressed/Flexible Schedule: Available
Telework: Available
Position Description Title/PD#: Health Science Specialist (Senior Regulatory Affairs Officer)/ 02614-0
Relocation/Recruitment Incentives: Not Authorized
PCS Expenses: Not Authorized
Financial Disclosure Report: Not Required

To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 02/21/2018.

Time-In-Grade Requirement: Applicants who are current, permanent Federal employees and have held a GS grade any time in the past 52 weeks must also meet time-in-grade requirements by the closing date of this announcement. For a GS-14 position you must have served 52 weeks at the GS-13. The grade may have been in any occupation, but must have been held in the Federal service. An SF-50 showing your time-in-grade eligibility must be submitted with your application materials.
Time-In-Grade requirements also apply to former Federal employees applying for reinstatement and current employees applying under the Veterans Employment Opportunities Act of 1998 (VEOA).

Basic Requirement: You must possess a bachelor's or graduate/higher level degree in a major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position.

Specialized Experience: You must have one year of specialized experience equivalent to at least the next lower grade GS-13 in the normal line of progression for the occupation in the organization. Examples of specialized experience would typically include, but are not limited to: Experience dealing with regulatory, clinical, and technical issues regarding medical research; experience with regulations, standards, and policies related to human research protection; working with the laws, regulations, standards and policies related to research safety and security; applying a wide range of qualitative and quantitative analytical and evaluation methods and techniques related to medical research; developing and implementing educational programs for medical research; and verifying appropriate compliant design of medical research projects and effective monitoring and evaluation of those projects.

Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religions; spiritual; community; student; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.

A full year of work is 35-40 hours of work per week. Part-time experience will be credited based on time spent in appropriate activities. Applicants wishing to receive credit for such experience must indicate clearly the nature of their duties and responsibilities in each position and the number of hours a week spent in such employment.

Physical Requirements: None, this is a sedentary position.

To apply for this position, you must provide a complete Application Package which includes:

  1. Resume
  2. If you are currently employed in the Federal government, include your most recent SF-50 showing title, series, and grade.
  3. If you have previously held a higher grade and are applying based on that grade, you must provide a copy of the SF-50 showing you held the higher grade in addition to your last or most recent SF-50 indicating proof of status. Note: Your SF-50 must reflect the grade and step information equivalent to or greater than the grade lower than the position you are applying to. This may not always be your most recent SF-50. You may need to submit more than one SF-50.
  4. If prior military service, include all copies of your DD-214 or proof of service as well as proof of disability, if applicable.
  5. Transcript(s).

The following documents are accepted, and may be required if applicable to your eligibility and/or qualifications for this position. Please use this checklist to make sure you have included other documents required for your application, such as a copy of your transcript (if using education to qualify), documentation to support Veterans Preference claims, or ICTAP/CTAP documentation (for displaced Federal employees). You will not be contacted for additional information.
  • Cover Letter
  • DD-214
  • Other
  • Other Veterans Document
  • Resume
  • SF-15
  • SF-50
  • Transcript


Veterans' Preference: When applying for Federal Jobs, eligible Veterans should claim preference for 5pt (TP), 10pt (CP/CPS/XP), or for Sole Survivor Preference (SSP) in the questionnaire. You must provide a legible copy of your DD214(s) which shows dates and character of service (honorable, general, etc.). If you are currently serving on active duty and expect to be released or discharged within 120 days you must submit documentation related to your active duty service which reflects the dates of service, character of service (honorable, general, etc.), and dates of impending separation. Additionally, disabled veterans and others eligible for 10-point preference (such as widows or mothers of eligible Veterans) must also submit an SF-15 "Application for 10 Point Veteran Preference" with required proof as stated on the form. Documentation is required to award preference. For more information on Veterans' Preference, please visit http://www.fedshirevets.gov/job/vetpref/index.aspx.
Qualifications & Requirements

To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 02/21/2018.

Time-In-Grade Requirement: Applicants who are current, permanent Federal employees and have held a GS grade any time in the past 52 weeks must also meet time-in-grade requirements by the closing date of this announcement. For a GS-14 position you must have served 52 weeks at the GS-13. The grade may have been in any occupation, but must have been held in the Federal service. An SF-50 showing your time-in-grade eligibility must be submitted with your application materials.
Time-In-Grade requirements also apply to former Federal employees applying for reinstatement and current employees applying under the Veterans Employment Opportunities Act of 1998 (VEOA).

Basic Requirement: You must possess a bachelor's or graduate/higher level degree in a major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position.

Specialized Experience: You must have one year of specialized experience equivalent to at least the next lower grade GS-13 in the normal line of progression for the occupation in the organization. Examples of specialized experience would typically include, but are not limited to: Experience dealing with regulatory, clinical, and technical issues regarding medical research; experience with regulations, standards, and policies related to human research protection; working with the laws, regulations, standards and policies related to research safety and security; applying a wide range of qualitative and quantitative analytical and evaluation methods and techniques related to medical research; developing and implementing educational programs for medical research; and verifying appropriate compliant design of medical research projects and effective monitoring and evaluation of those projects.

Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religions; spiritual; community; student; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.

A full year of work is 35-40 hours of work per week. Part-time experience will be credited based on time spent in appropriate activities. Applicants wishing to receive credit for such experience must indicate clearly the nature of their duties and responsibilities in each position and the number of hours a week spent in such employment.

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Contact Information
Contact Name:
Company Name: Veterans Affairs, Veterans Health Administration
Phone Number:
Fax Number:
Contact Email:CAVHS.DEU@VA.GOV
Website:http://www.ecentralmetrics.com/url/?u=63589551160%2D39&r=http%3A%2F%2Fwww%2Evacareers%2Eva%2Egov%2Fjob%2Dsearch%2Fjob%2Ddetail%2Easp%3Fjob%3D310503
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