- Lead the development and strategy for clinical regulatory submission documents and other clinical documents
- Experience authoring clinical study protocols and amendments, clinical study reports, investigator brochures and updates, and module 2 summaries
- supporting ALL clinical project teams by contributing to briefing packages, responses to health authorities, global regulatory submission and other IND/CTAs and more
- Working as a medical writing lead by maintaining SOPs with statistical, clinical, regulatory, quality and drug safety teams
- directing and mentoring other medical writing junior staff to help with development and and production of clinical regulatory documents
