High-level clinical documents play a critical role in regulatory decision-making but are often approached as template-driven summaries rather than interpretive narratives. This article provides a comprehensive, narrative-driven roadmap for crafting high-quality clinical summaries (Modules 2.7.1–2.7.4) and the Clinical Overview (Module 2.5) for EMA submissions. Moving beyond template-based writing, it demonstrates how medical writers can synthesise programme-level evidence, articulate clinical relevance, and construct a transparent benefit–risk argument. Expanded examples using a fictional drug, AXP-101, illustrate what effective, high-level writing looks like in practice, helping both new and experienced writers understand regulatory expectations and produce reviewer-friendly documents intended to remain relevant for the next decade.