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Fred Hutchinson Cancer Center

Multiple Locations, Washington

University of Utah

Salt Lake City, Utah

IEHP

RANCHO CUCAMONGA, California

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CHRISTUS Health

Corpus Christi, Texas

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CHRISTUS Health

Beaumont, Texas

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Childrens Health

Dallas, Texas

University of North Carolina Wilmington

Wilmington, North Carolina

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Kindred Hospitals

Dayton, Ohio

The Henry M. Jackson Foundation for the Advancement of Military Medicine

Bethesda, Maryland

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Kindred Hospitals

Indianapolis, Indiana

City of Hope

Duarte, California

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CHRISTUS Health

Texarkana, Texas

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CHRISTUS Health

Corpus Christi, Texas

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Mass General Brigham

Somerville, Massachusetts

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Regulatory Affairs Professional
Advise on responses to technical questions raised by US FDA and Health Canada, or other regulatory authorities. Responsible for submission of documents to US FDA and Health Canada, or other regulatory authorities, such as a 483 inspection response. Evaluate classification of drug recalls, implementation of recalls. Evaluate, advise and prepare Field Alert Reports. Evaluate, advise and prepare Recall Reports. Monitor resolution of situations involving compliance issues. Participates in the enforcement of compliance of establishments and products, with current good manufacturing practices (CGMP) and other adulteration provisions of the Title 21 of the Code of Federal Regulations and Federal Food, Drug and Cosmetic Act. 


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