FDA Regulatory Specialist
Oregon Health & Science University, Knight Cancer Institute
The OHSU Knight Cancer Institute, known as one of the pioneers in personalized cancer medicine, is an international leader in research and cancer treatment. Driven by its mission to end cancer as we know it, the institute is building upon its expertise in targeted treatments to advance the early detection of cancer when the disease is most treatable.
The mission of the Knight Clinical Research Quality & Administration group (CRQA) is to foster a supportive environment conducive to achieving the Knight’s clinical research mission. CRQA provides a central location for policies, procedures, and systems to aid investigators and research groups with respect to trial development, execution, and oversight.
The FDA regulatory specialist provides support to OHSU investigators that hold individual filings with the Food and Drug Administration [FDA]; specifically, Investigational New Drug [IND], Investigational Device Exemptions [IDE] or other filings. This position facilitates adherence to compliance requirements related to IND, IDE, etc. applications and assists with preparation of materials to submit directly to the Food and Drug Administration [FDA] for both initial applications and application maintenance. Utilizing clearly defined expectations and effective communication skills, this position works directly with investigators to strengthen the quality of their FDA submissions.
As requested by Knight Leadership, this position is also responsible for collaborating on the development of multi-center investigator-initiated trial [IIT] management procedures and tools, and for providing guidance & training relative to the position responsibilities described above.
Master’s degree in relevant field and 3 years of relevant experience; OR
Bachelor’s degree in relevant field and 5 years of relevant experience.
For more information or to apply online, visit the job
on the OHSU Careers site
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