- Author and manage ALL clinical documents while establishing timelines for clinical study protocols, clinical study reports, investigator's brochures, clinical technical components, risk management plans and module summaries
- Author IND/CTA and global regulatory submission documents
- Actively support clinical project teams by taking responsibility for medical writing deliverables and negotiating timelines
- Review, edit and ensure quality of all documents
- Effectively collaborate with statistical, clinical, regulatory and pharmacovigilance teams
