• Writing of documents in the electronic common technical document (eCTD) format including clinical summaries and clinical overviews
• Responses to questions from authorities
• Writing of clinical study reports (CSRs)
• Writing/co-authoring of:
  • Statistical Analyses Plans (SAPs) for pooled analyses
  • Briefing Books
  • Investigational Brochures (IBs)
  • Orphan drug designation applications
  • Risk Management Plans (RMPs)
  • Summaries of Product Characteristics (SmPCs)
  • Paediatric Investigation Plans (PIPs)