Danielle Hugo

I have extensive experience in research, reviewing, editing, formatting, and writing including medical writing Medical devices and Pharmaceuticals as well as through my studies.
I am currently working as a Senior Medical Writer, remotely from Oudtshoorn, Western Cape, for Synterex, based in the United States. My responsibilities include supporting the preparation of regulatory submissions for health authorities in the United States, including non clinical documentation, patient narratives, Quality Control QC, Development Safety Update Report DSUR, and Investigator Brochures IB.
From 2019 – 2022 I worked remotely as a Clinical analyst / medical writer for Regular Services, based in Germany. My work entailed: Clinical Evaluation Reports according to MEDDEV[removed]and European Regulation[removed]MDR, supporting the implementation of national and international regulatory requirements in the area of regulatory affairs and quality management systems for medical device manufacturers