At the full performance level, the incumbent performs duties that include resolving a broad range of issues concerning the application of any of FDA's enabling policies affecting the operation of the Federal government. In addition, the incumbent provides policy analysis on national tobacco and smoking regulations. Assignments are often complicated by the need to resemble complex or controversial issues of wide public interest and to revise existing or create new innovative policies. Major duties include:
· Develops policies and programs involving complex and priority matters affecting FDA regulated products. Drafts or critically reviews documents embodying policy and program proposals and decisions.
· Participates in ORA's and FDA's rulemaking and guidance development activities.
· Develops and maintains communications, policies, and programs with regard to policy research, development and implementation.
· Serves as an expert as policy analyst and is frequently called on to advise others concerning FDA policies.
· Develops and drafts a wide range of policy documents, often leading working groups within ORA and participation on behalf of ORA on FDA-wide working groups or teams.
· Reviews, summarizes, and drafts responses to public comments received on proposed policies; recommends adoption or rejection of counter-proposals contained in comments and objections; drafts final policies.
· Initiates decision-making processes and documents and participates fully in discussions and decisions concerning ORA plans, programs, and activities, both in strategic planning and in the actual determination, allocation, and administration of ORA program segment(s), functions and activities.
· Prepares replies to correspondence from the regulated community and other interested parties on issues that are industry-wide in scope or have broad health implications and that concern interpretations of FDA policy.
· Advises other offices in ORA on procedures and methods for implementing new policies and revising existing policies and on the procedural adequacy of proposed policy statements and policy initiatives.
· Analyzes and evaluates the implementation of new policies that impact ORA's mission.
· Makes presentations at conferences and professional meetings in the U.S. and, possibly overseas before stakeholders on the applicable policies.
· Provides guidance and/or training to policy specialists and other professionals within FDA on matters relating to his/her expertise.
Duties at the trainee levels will be selected by the supervisor and will be developmental in nature.