Regulatory Health Program Coordinator GS-601-12/13
***Closes 5/5/20! Only applications submitted via USAJOBS at the link below along with appropriate supporting documentation, including transcripts, will be considered:
https://www.usajobs.gov/GetJob/ViewDetails/550844600
Summary
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), Office of Medical Products and Tobacco, Center for Tobacco Products (CTP), Office of Science (OS), located in Beltsville, Maryland.
Responsibilities/Job Duties:
- Serves as a regulatory lead on scientific project and/or review teams; ensures compliance with all legal, regulatory and policy requirements.
- Works with the review team (scientific, regulatory and management) to develop project plans.
- Manages the tobacco product review process from initial submissions to the time of regulatory action.
- Serves as contact point for communications concerning regulated product applications and other scientific projects.
Qualifications:
In order be eligible for the position of Regulatory Health Program Coordinator (Direct Hire), (GS-0601-12/13), you must meet the following requirements by 11:59 pm (Eastern Time) on 05/05/2020.
Basic Requirement: This position has a Basic Individual Occupational Requirement (IOR). In order to meet the basic IOR you must possess a Bachelor's degree or higher graduate degree in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. You must submit an unofficial transcript to show that you meet the basic IOR in order to be considered for this position.
In addition to the Basic Individual Occupational Requirement (IOR) you must also meet the following specialized experience requirement:
For GS-12: You must possess 1 year of specialized experience equivalent at to the GS-11 grade level in the Federal service, applying knowledge of scientific methods and regulatory policies to formulate and manage regulated products research and review projects; applying project management principles in planning and organizing concurrent activities and anticipating subtle and difficult issues; and providing oral and written briefings and recommendations concerning projects.
For GS-13: You must possess 1 year of specialized experience equivalent to the GS-12 grade level in the Federal service,
applying knowledge of scientific methods and regulatory policies to formulate and lead regulated products research and review projects; applying project management principles to lead, manage and coordinate team activities; and providing technical guidance to resolve program problems.