Responsible for the planning, development, authoring, review, and finalization of clinical and regulatory documents, including clinical study protocols and amendments, clinical study reports (CSRs), Investigator’s Brochures (IBs), regulatory briefing documents, clinical summaries and overviews, responses to health authority questions, and other documents supporting global regulatory submissions. · Provides strategic medical writing leadership and develops document strategies in collaboration with Clinical Development, Regulatory Affairs, Clinical Operations, Biostatistics, Data Management, Pharmacovigilance/Safety, and other cross-functional stakeholders.