Let me introduce myself
In 2010, I started as a freelance medical writer after working as a medical writer for a clinical research organisation and a biotech company for over 12 years. Besides writing regulatory documents for the clinical and regulatory departments, I have experience with medical communication documents for the marketing and medical affairs departments. In addition I am active as a translator of a diversity of German and English medical documents (e.g. SmPC and patient leaflet) into the Dutch language.
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Regulatory documents
All regulatory documents are based on the ICH/GCP guidelines or EudraVigilance templates.
• Clinical study protocols and amendments
• Investigator Brochures
• Clinical study reports: Phase I, Phases II-IV
• CTD: Summary of Clinical Safety; Summary of Clinical Efficacy; Clinical Overview
• Periodic Safety Update Reports
• Annual Safety Reports
• Risk Management Plans
Medical communication
The medical communication documents I have
written are listed below.
• Manuscripts
• Abstracts
• Posters
• Slide sets
• Proceedings of conferences
• Annotations
• Publication plans
• Product monographs