Regulatory Health Information Specialist

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.

Documenting experience:  In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description.  Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above.

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.  For further information, click on foreign education.