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.

Who May Apply:  Federal employees with career or career-conditional appointments in the competitive service; former Federal employees with reinstatement eligibility based on previous career or career-conditional appointments;

This position is located in Food and Drug Administration (FDA), Center for Drug Evaluations and Research (CDER), Office of Medical Policy (OMP), in Silver Spring Maryland.

Duties

  • Patient product information may consist of Medication Guides, which are subject to FDA regulation, patient package inserts, which are voluntary and maybe included as part of product labeling;
  • Responsible for making recommendation to ensure that risks and indications are adequately communicated to patients;
  • Compare the patient labeling to the professional labeling to ensure consistency in content and that FDA requirements are consistent and equitably applied to all patient labeling and related materials;
  • Must be concise, easily  evaluated, and utilize knowledge of the drug review and drug labeling requirements;
  • Work with senior staff to review special and unusual problems submitted by various Centers and provide authoritative guidance and conduct research into legal precedent and legislative history of the Acts enforced by FDA;
  • Act as liaison between the Office and other agency units, includes review divisions and participates in negotiation with firms as appropriate;
  • Initiate communication (oral and written) regarding FDA regulatory  decisions, policy matters, or request for information from regulated industries;
  • Participate at meetings of major groups (such as industry, federal government, professional associations and consumer groups) to share policies and best practices; and
  • Negotiate the timely resolution of scientific and regulatory conflicts or problems to avoid delays in achieving goals.