Regulatory Health Information Specialist
The FDA Center for Tobacco Products is hiring!
***The closing date on the announcement is January 30, 2020 at Midnight EST! Only applications submitted to USAJOBS via the link below with all appropriate documentation
(e.g. unofficial transcripts) will be considered:
Regulatory Health Information Specialist
The Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) regulates the manufacturing, marketing, and distribution of tobacco products. Our goal is to reduce the harm from all regulated tobacco products across the entire population, including: reducing the number of people who start to use tobacco products, encouraging more people to stop using these products, and reducing the adverse health impact for those who continue to use these products. CTP's actions have significant public health and consumer protection impact and are among the most important issues faced by the Agency in its long and distinguished history.
The Center for Tobacco Products (CTP) is responsible for implementing the Family Smoking Prevention and Tobacco Control Act. This law gives FDA authority over tobacco products by adding a new chapter to the Food, Drug, and Cosmetic Act. The Tobacco Control Act gives FDA the authority to regulate tobacco products and manufacturers based on the best available science and CTP is responsible for both assessing and fostering that science-base. CTP's actions have significant public health and consumer protection impact and are among the most important issues faced by the Agency in its long and distinguished history.
This position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Center for Tobacco Products (CTP), Office of Science (OS) located in Beltsville, Maryland.
- Serves as a team member of the regulatory health information systems staff that supports CTP?s scientific review programs and activities.
- Coordinates all enhancements to the Center?s data information systems which pertain to the products regulated by the Office.
- Analyzes regulatory review and scientific health information/data needs of the office in relation to existing capabilities for providing information to management on a variety of topics associated with regulatory review process.
- Provides training to a variety of users, reviewers, and managers on how to use the system, types of information available, and reporting capabilities.
- Coordinates and provides both 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.
In order be eligible for the position of Regulatory Health Information Specialist, (GS-0601-11/12/13), you must meet the following requirements...
Have successfully completed a course of study at an accredited college or university leading to a bachelor's or higher degree with a major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. (You must submit a transcript)
MINIMUM QUALIFICATIONS REQUIREMENTS:
I have one year of specialized experience equivalent to the GS-9 grade level in the Federal service, to include experience the designing or operating information systems, programs or equipment and verifying the adequacy of such activities as it relates to field investigations, testing of operations or research conclusions.
I have a Ph.D. or equivalent doctoral degree or 3 academic years of progressively higher level graduate education, or LL.M, if related.
I have one year of specialized experience equivalent to the GS-11 grade 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.
I have one year of specialized experience equivalent to the GS-12 grade level in the Federal service, to include training, developing, leading and/or managing a wide range of end-users, regulatory and scientific data management information systems.