• Primary author of phase 1-4 protocols, IBs, CSRs, master ICFs, eCTD modules for INDs and BLAs, briefing documents for scientific advice, specialty regulatory documents like PIPs, ODDs, aggregate reports, RFIs, and other documents required for drug development • Engages relevant SMEs and document owners to develop content that is well-organized, consistent, accurate, and appropriate for a regulatory audience • Responsible for inspection-readiness of medical writing activities • Facilitates standardization of documents using document templates, lexicons, and argenx style guide to ensure the quality and consistency of documents across programs • Manage medical writers (in-house FTEs, contractors, and external vendors) who are individually contributing to the MW activities for a variety of regulatory documents • Collaborates with project teams, including program leader, clinical study managers, biostatisticians, and medical directors, to ensure project deadlines are met • Responsible for inspection-readiness of medical writing activities • Responsible for medical writers assigned to support the medical writing activities for a particular project • Executes corporate objectives, goals, measures, and strategies and begins to inform the development of them • Capable of working on multiple deliverables simultaneously