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This position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Offi Center for Biologics Evaluation and Research (CBER), Office of Cellular, Tissue and Gene Therapies (OCTGT), Human Tissue and Reproduction Branch (HTRB), Rockville, MD.
This vacancy is also being announced concurrently with vacancy announcement FDA-CBER-13-DE-1008750-GP under merit procedures. Please review that announcement to see if you are eligible for consideration under competitive procedures. NOTE: Applicants must apply separately for each announcement in order to be considered.
Who May Apply:
Open to all United States Citizens.
Identify, evaluate and provide recommendations to inform regulatory and policy issue related to implementation of CGTP requirements in tissue establishments.
Assess impact of regulatory policy on stakeholders.
Evaluate compliance actions related to tissue establishment.
Review, analyze and summarize research data to provide expert review of regulatory submissions of infectious disease assays.
Review, analyze and summarize research data to provide expert opinion regarding its application to regulatory policy decisions.
Review, analyze and summarize research data to provide expert opinion about research studies or initiatives that are needed to further inform regulatory and policy decisions.
Write scientific manuscripts for publication and other scientific documents.
Develop and recommend new and revised regulatory correspondence for regulated tissue products.
Develop policy documents.
Present regulatory, policy and scientific information at local, state and national meetings to regulated industry, agency staff and other stakeholders.
Present at national conferences.
Mentor staff on regulatory policy.