What Makes A Great Medical Writer?

Regulatory writing is often misunderstood as simply the ability to craft technically correct, well-structured sentences and to organize content within templates. In reality, great regulatory writers are strategic thinkers, skilled analysts, and expert communicators who bridge science and regulatory expectations.

While strong writing is foundational, what truly sets great regulatory writers apart is their ability to think like regulatory reviewers. Many of you reading this article have heard me say in workshop sessions that “every great writer is always thinking about their reading audience and what their audience needs in documents to facilitate decision-making.” Great regulatory writers bring scientific fluency, regulatory insight, information design skills, and a deep understanding of how health authorities read and decide.

Scientific and Regulatory Fluency
Great regulatory writers do not just write about science—they understand it. Their fluency spans:

• Clinical trial design – Knowing how studies are structured, analyzed, and reported.
• Pharmacology and therapeutic context – Understanding mechanisms of action, PK/PD, and safety considerations.
• Regulatory expectations – Navigating FDA, EMA, PMDA, and ICH guidance with confidence.

While an average writer transcribes and rewords SME input, a great writer interrogates the data, anticipates regulatory questions, and frames key arguments. They engage SMEs with targeted questions, uncover rationales, test assumptions, and shape content into precise, persuasive messaging. Collaboration becomes a strategic dialogue—not just an information handoff.

Strategic Thinking and Persuasion
Regulatory briefing books and Module 2 dossiers are not neutral summaries—they are interpretive and often persuasive instruments. Whether drafting a Clinical Overview or responding to agency queries, great writers shape how the data is understood and weighed. That’s where advanced writing actions come in:

• Justify – Writers explain why a design, method, or decision was sound, drawing on evidence, precedents, and clinical logic. For example, justifying a single-arm trial due to disease rarity or unmet need.
• Argue – Writers build structured cases: making claims, supporting them with data, and addressing counterpoints. Argumentation is central in briefing books, Clinical Overviews, and benefit-risk assessments.
• Interpret – Writers do not just report results—they make the results meaningful. For example, they show what a treatment effect implies contextually in a patient population and how the interpretation supports approval.

Strategic writers weave together data, rationale, and regulatory expectations to guide the reader toward a clear, supportable “So what?” conclusion.

From Data to Knowledge: Mastering the Continuum
Perhaps the most critical competency of great regulatory writers is transforming data into regulatory knowledge—a progression essential to support effective regulatory decision-making:

• Data: Raw clinical and statistical outputs.
• Information: Organized summaries, tables, and figures.
• Knowledge: Interpretation that answers “What does this mean for approval?”

Great writers move beyond reporting to deliver actionable insights. They help regulatory readers see the
implications of the data—and how those implications align with policy, precedent, and public health
goals.

Information Design: Optimizing for Decision-Making
Great regulatory writers are also information designers. They understand how layout, structure, and hierarchy support—or hinder—regulatory decision-making. Good information design lowers cognitive load and accelerates comprehension.

Great writers adapt their approach based on document type, review timelines, and information volume. They help regulatory readers by:

• Placing key insights where readers expect them (that is, top of sections and preceding tables and figures).
• Minimizing redundancy to reduce reader fatigue.
• Using formatting and white space to support navigation and retention.

These writers do not just present data, they design documents to enhance regulatory reader cognition.

Final Thought: Great Writers Think Beyond Writing
The best regulatory writers are not just technical specialists. They are strategic partners who combine
writing with science, persuasion, design, and foresight. They transform information into knowledge—and knowledge into action.

Check out my LinkedIn to see what others are saying about this article: ​https://www.linkedin.com/in/gregorycuppan/

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