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Regulatory Health Information Specialist

FDA

RemoteFull timeMid levelPosted today
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About the role

Duties

  • Serve as project leader and manager of the regulatory health information systems that support CTP's scientific review programs and activities.
  • Organize and maintain information or information management systems.
  • Prepare periodic and special reports pertaining to product review status and other matters related to various scientific and regulatory review and research activities handled by the office.
  • Provide technical advice on exchanging information regarding the design, development, and utilization of information management systems in support of regulatory review.
  • Provide training to a variety of users, reviewers, and managers on how to use the system, types of information available, and reporting capabilities.

Qualifications

Basic Qualification Requirements for GS-0601, Regulatory Health Information Specialist:

All applicants must complete 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 related to the health sciences or allied sciences appropriate to the work of the position.

In addition to meeting the Basic Qualification Requirement you must also meet the following:

GS-12: All applicants must have one year of specialized experience, equivalent to the GS-11 level in the Federal service, to include performing quality assurance checks on scientific or regulatory data and maintaining regulatory and scientific data management information systems.

GS-13: Have one year of specialized experience, equivalent to the GS-12 level in the Federal service, to include providing guidance in analysis of regulatory and health information/data pertaining to scientific review programs and activities.

Education

If you are claiming education as any part of your qualifications for this position, you must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program.

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