Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
The Regulatory Affairs Associate is responsible for providing support and guidance to investigators and others within the Cancer Consortium (Fred Hutch, UW, SCCA, Seattle Children’s) on regulatory issues and requirements related to the conduct of clinical trials and use of investigational products. The incumbent will facilitate communications with the FDA, provide support to study teams in the preparation and review of FDA submissions and other regulatory documents, and assist with FDA inspections. This position will represent the Regulatory Affairs Program to the Institution and Cancer Consortium by making presentations to staff, disseminating tools and information, and meeting with study teams and other departments on an ad hoc basis. The incumbent will work under the direction of the Director of Regulatory Affairs and Compliance.
Experience and Abilities
Knowledge and Skills