Description of Duties
As a Regulatory Information Specialist, you will:

• Participate in the overall planning, development and analysis of regulatory information management requirements and their implementation in the Center for Drug Evaluation and Research (CDER) Informatics Platform.
• Translate user requirements into business needs and work with CDER end-users to iteratively configure a solution that meet their regulatory information needs.
• Work closely with the CDER Informatics Capability Teams to identify gaps and jointly prioritize and build plans for addressing them.  Provide detailed functional requirements for gaps identified and perform testing and verification to ensure adequacy of proposed solutions.
• Document reporting needs to support a complex regulatory work process.

Qualifications
In order to qualify for the Regulatory Information Specialist, GS-301-9/11, you must meet the following:

Basic Requirement:
GS-09:
Have one year of specialized experience, equivalent to the GS-7 grade level in the Federal service that includes identifying issues and resolving critical problems associated with regulatory information management projects, OR
Have completed two full years of progressively higher level graduate education, or possess a master's or equivalent graduate degree, or LL.B. or J.D., if related OR
Have a combination of specialized experience and graduate level education that meets 100% of the qualification requirements for this position.
GS-11:
Have one year of specialized experience, equivalent to the GS-09 grade level in the Federal service that includes identifying and developing solutions to meet user needs related to the review of drug regulatory submissions, OR
Have completed 3 full years of progressively higher level graduate education OR possess a Ph.D. or equivalent doctoral degree, OR
Have a combination of graduate level education beyond the first 2 years of progressive graduate study and specialized experience that together meets 100% of the qualification requirements for this position.

Additional Requirements may be required.

Grade (Salary) Level:
Federal General Schedule (GS) grade levels at which Regulatory Information Specialists are commonly filled are:

• GS-301-9/11

Geographical Location:
Regulatory Information Specialists are located at HQ (suburban Washington, D.C.)