Course Development: Intermediate Medical Writing, Investigational Applications

We are looking for an experienced subject matter expert (SME) to develop our Intermediate Medical Writing: Investigational Applications course with the most up to date regulations and practices. This course will provide an overview of the variety of investigational applications prepared by regulatory and medical writers for both drugs/biologics and medical devices. Key investigational submissions covered include region-specific applications for drugs/biologics such as the Investigational New Drug Application (IND), Canadian Clinical Trial Application (CTA) and Investigational Medicinal Product Dossier (IMPD), as well as those required for investigational devices such as the Investigational Device Exemption (IDE), European CTA and Investigational Testing Authorization (ITA).