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.

As a Regulatory Health Project Manager in the Division of Epidemiology, Office of Biostatistics and Epidemiology (OBE), Center for Biologics Evaluation and Research (CBER), you will serve as project manager for a number of the division's review teams and is responsible for the planning, focusing, and coordinating of the teams' activities within the division.  

This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-CBER-MP-13-960505 under merit promotion procedures.  Please review that announcement to see if you are eligible for consideration under merit promotion procedures.  NOTE:  Applicants must apply separately for each announcement in order to be considered.

This job opportunity announcement may be used to fill additional vacancies.

Duties

  • Manages the biologic review process for multiple biologics.
  • Ensures compliance with all legal, regulatory, and policy requirements in assigned biologic classes.
  • Facilitates the timely completion of project activities and attainment of project objectives within established project plans.
  • Coordinates the resolution of conflicting resource needs, availability and scheduling.
  • Serves as primary contact for all communications concerning applications for biologic classes.
  • Collaborates with scientific, regulatory, and management team members to develop project plans.