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:  This vacancy is open to current Food and Drug Administration (FDA) employees within the Office of Compliance with competitive status only.  Competitive status refers to employees who are serving on a career or career conditional appointment.. 

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

YOU MUST SUBMIT YOUR SF-50 (AND DD-214 IF APPLICABLE).

This position is located in Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Drug Security, Integrity, and Recalls (ODSIR) in Silver Spring, MD.

This announcement may be used to fill multiple positions in multiple locations.

Duties

Major Duties:

Serves as the technical scientific authority in areas including but not limited to case management, guidance and policy development, international agreements, compliance evaluations, data integrity, post-marketing, and risk evaluation and mitigation strategies;

Utilizes strategic thinking and decision making to develop and refine program priorities and goals;  

Ensures ongoing and appropriated communication with key Agency customers in the area of assigned responsibility; 

Facilitates resolutions of difficult regulatory issues via rigorous scientific inquiry and interactions with internal and external constituents, including industry organizations and other Agency components; 

Conceives of the mission for groups, independently develops propositions for study and speaks for the Division and the Office on matters in the area of regulatory responsibility;

 

Leads in the establishment of a consensus with FDA scientific, technical and medical personnel to establish precedence for compliance action or identify and recommend FDA position when policy is nonexistent or inapplicable;

  

Collaborates and cooperates on developing briefings, seminars, workshops and other outreach communication efforts on scientific risk-based compliance initiatives to achieve consensus; plans, and develops, prepares, coordinates and provides regulatory, educational and instructional information for internal and external uses;

 

Represents the Agency at meetings and conferences in his or her area of scientific expertise and deals with controversial issues or regulatory policies; and provides the Agency's view on important matters to gain consensus on regulatory positions and issues; 

 

Independently plans, designs, and carries out case policy review assignments and research projects to completion;  

 

Develops scientific guidelines, Agency policy, and programs which may involve complex and high priority matters affecting the regulation of drugs.