Job Overview

Summary

Become a part of the Department that touches the lives of every American!  At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere.  It is the principal agency for protecting the health of citizens.  Join HHS and help to make our world healthier, safer, and better for all Americans.

The FDA's Office of Regulatory Affairs is the lead office for all FDA Field activities as well as providing FDA leadership on imports, inspections, and enforcement policy.  ORA supports FDA Product Centers by inspecting regulated products and manufacturers, conducting sample analysis on regulated products, and reviewing imported products offered for entry into the United States.  ORA also develops FDA-wide policy on compliance and enforcement.

WHO MAY APPLY:  This vacancy is open to current permanent (career/career-conditional appointments) employees of the Food and Drug Administration (FDA) ONLY.  Current FDA employees serving under a Schedule-A OR VRA appointment are eligible for consideration. Title 42 employees not eligible for reinstatement will not be considered. 

YOU MUST SUBMIT YOUR SF-50 (Notification of Personnel Action)

Current FDA Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement.  Candidates will be referred to the selecting official as Commissioned Corps (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.

LOCATION:  This position is located in the Food and Drug Administration, Office of Global Regulatory Operations and Policy, Office of Regulatory Affairs, Office of Policy and Risk Management in Rockville and Silver Spring, Montgomery County,  Maryland.  
The salary listed in the vacancy announcement includes the geographical locality pay.

 

TYPE OF POSITION: This position is being filled on a full-time, permanent basis.

PROMOTION POTENTIAL: This is a career-ladder position; GS-13 is the full performance level.
Additional selections may be made from this announcement.

Duties

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.