David Brown
Clinical Regulatory Writing Program Lead, Vaxzevria and Flumist @AstraZeneca
Signup · Get unlimited contacts
WORK HISTORY
Clinical Regulatory Writing Program Lead, Vaxzevria and Flumist @AstraZeneca
Gaithersburg, MD, US
Led medical writing team that supported the submission and approval of Vaxzevria (Oxford/AstraZeneca COVID-19 vaccine) in EU, UK and Rest of World markets. Co-ordinated team of 25 medical writers and worked highly cross-functionally with physicians, statisticians, programmers, immunologists and regulatory professionals to author and deliver multiple MAA submissions, Type 2 variation submissions and regulatory responses under intense time pressure. Wrote key documents including Clinical Overviews, Clinical Summaries of Efficacy and Safety, briefing documents and regulatory response documents. Led development of company-wide training on lean authoring and strategic review.
EDUCATION
University of Oxford
MA, English Language and Literature
The University of Sheffield
MMedSci, Sports and Exercise Science
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.