• Independently author and review complex clinical and regulatory documents, including clinical trial protocols, clinical overviews, and summaries in CTD/eCTD format for regulatory submissions. • Draft and edit more strategic documents, such as Health Authority briefing books, responses, and publications (abstracts, posters, slide presentations, and manuscripts for scientific journals). • Represent medical writing on internal teams such as the Clinical Trial Team, protocol review committee, and regulatory submission teams. • Lead submission team activities and oversee the preparation of critical documents. • Facilitate team participation in document preparation, including scheduling meetings, developing timelines, and managing document reviews and decisions. • Act as a mentor for new employees and consultants and serve as a role model for junior writers. • Lead the development and review of standard processes and templates. • Support ongoing improvements in cross-functional and global collaboration, sharing best practices and knowledge.