Center for Tobacco Products
The Center for Tobacco Products is offering Detail opportunities for Regulatory Health
Information Specialist, GS-601-12/13. Applicants at the GS-12 and GS-13 levels are
encouraged to apply. The Detail is available immediately for a period of 120 days.
Bargaining Unit Status: Bargaining Unit Position
Office Location: FDA
Center for Tobacco Products
9200 Corporate Blvd.
Rockville, MD 20850
Opening Date: February 8, 2011
Closing Date: February 22, 2011
Area of Consideration: HHS-Wide
The Center for Tobacco Products offers a fast-paced, dynamic environment and an opportunity
to work with dedicated, energetic people who really want to make a difference and improve
public health. The position is ideal for someone who wants to have a critical role in the
organization and would enjoy the challenge of handling a variety of assignments related to the
regulation of tobacco products.
The selected employee will serve as the project leader and manager of the regulatory health
information systems that support CTP’s scientific review programs and activities. The duties
Serving as either a leader or co-leader of interdisciplinary project teams to gather,
analyze, document, communicate, and validate requirements for business processes,
policies, and information systems to support implementation of a managed review
process and various provisions of the Family Smoking Prevention and Tobacco Control
Analyzing regulatory review and scientific health information/data needs of the Office of
Science in relation to existing capabilities for providing information to reviewers, and
management on a variety of topics associated with the regulatory review process and
Determining the need(s) to create methods and procedures for obtaining and storing
entirely new types of information, often concerning state-of-the-art science related to
products regulated by the CTP.
Performing quality assurance activities pertaining to the integrity and accuracy of
scientific and regulatory information already in the system and new data entered into it.
Reviewing and testing enhancements made by contractor as a means of assuring quality
control and acceptability of work by contractor.
Determining reporting needs of reviewers and senior managers and assuring that a wide
variety of periodic and special reports are provided.
Training a variety of users, reviewers, and managers on how to use the system, types of
information available, and reporting capabilities.
Desired Knowledge and Skills:
Knowledge of the scientific/medical information in submissions for tobacco product
and/or other FDA-regulated products, to identify specific data needs and to identify areas
where the reporting capabilities of data systems need to be enhanced or modified.
Knowledge of the regulatory review process for regulated products to help identify the
need for specific data fields and to develop reports that meet specific decision-making
Ability to manage projects and resources, the ability to meet project goals, and skill in
planning and organizing the work of project teams to accomplish a variety of concurrent
Excellent organizational skills.
Skill in working collaboratively.
Excellent oral and written communication skills.
Supervisory concurrence should be obtained before you apply to this detail. The detail
opportunity is open to all candidates qualified for the GS-12 and GS-13 grade level or
Commissioned Corps officers.
Interested applicants should submit a copy of their resume, most recent copy of SF-50, and
statement of interest via email to:
Office of Management, Center for Tobacco Products, FDA
Detail is reimbursable.
Travel Expenses will not be paid.
Candidates must express interest by February 22, 2011
*This is not an official vacancy announcement under the Merit Promotion System