Course developer for Intermediate Medical Writing: Pharmaceuticals and Biologics

We are looking for an experienced subject matter expert (SME) to develop our Intermediate Medical Writing: Pharmaceuticals and Biologics course with the most up to date regulations and practices.

This course will provide an overview of some of the more complex documents prepared by regulatory and medical writers, with a focus on the Common Technical Document (CTD). Key considerations associated with writing submissions in CTD format, including region-specific considerations for clinical sections in US New Drug Applications (NDA), US Biologics License Applications (BLA) and EU Marketing Authorisation Applications (MAA) will be discussed. You will be introduced to the components of each of these application types and learn techniques for improving document quality in order to advance your career as a medical writer.