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Regulatory Specialist II
The Department of Cancer Immunology is seeking a Regulatory Specialist II who will serve as a central resource for faculty conducting clinical research at Johns Hopkins University and across multiple clinical trial sites. Working closely with the Sponsor-Investigator and IND Specialist, this position will assist in the submission of investigator initiated trials to the appropriate regulatory agencies for review, such as the Food and Drug Administration (FDA). In addition, this position will assist in the ongoing maintenance of Sponsor-Investigator held INDs. This includes, but is not limited to protocol amendments, Investigator Brochure amendments, annual reports, IND saf
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