Technical writing is at the heart of successful regulatory submissions and clinical documentation. Whether you're drafting a Clinical Evaluation Report (CER), a protocol, or a safety update, your ability to write clearly and efficiently determines how well your audience—regulators, clients, or internal stakeholders—understands and acts on your information.
Here are four essential tips that elevate your technical writing and help ensure your documents hit the mark every time.
1. Use Templates and Instructions to Build a Strong Foundation
Success in technical writing often starts with a basic principle we all learned early in life: follow the directions.
Each document type in medical writing—whether it's a Clinical Evaluation Report (CER), Periodic Safety Update Report (PSUR), clinical study protocol, or Investigator’s Brochure (IB)—has its own set of guidelines, templates, and expectations. These frameworks are not optional—they’re essential. They provide structure, define the required level of detail, and help align your work with regulatory expectations.
Pro Tip: Never assume the template or guidance you used last quarter is still current. Regulatory authorities (and clients) often update their expectations without fanfare. Always verify that you’re working from the latest version.
Even if the changes seem small or your task is “just an update,” always review the source template carefully. What seems like a routine revision may trigger new formatting, structure, or content requirements.
And when in doubt? Reach out for clarification, either from your client, a regulatory lead, or the competent authority. Early clarification prevents painful rework later on.
2. Write with Clarity: Be Clear, Concise, and Consistent
If you’ve ever had to reread a sentence multiple times to figure out what the author meant, you already understand how critical clarity is in technical writing.
The best technical documents are easy to read, even when the science is complex, because they stick to the three Cs:
Tactical Tips:
Every paragraph should serve a purpose. If it doesn't, cut it.
3. Understand and Respect the Scope of the Document
One of the most common pitfalls in technical writing is overwriting. It’s easy to assume that more detail equals a better document: but in reality, excessive information can obscure the message and dilute the reader’s focus.
Before you start writing, get crystal clear on the scope:
If you’re updating a document, also ask:
Collaborate Smartly: Talk to your client, colleagues, or regulatory SMEs. Review prior versions. Use all the tools at your disposal to make sure you’re not going too far, or not far enough.
A skilled writer knows when to dig deep and when to step back. That judgment makes a big difference in regulatory success.
4. Leave Time to Revise—Then Revise Again
Good writing is rarely good on the first try. The difference between a rough draft and a polished, professional submission is the time you spend editing and refining it.
Once you've completed your first draft:
Remember: The goal isn’t just to finish the document. It’s to deliver something so clear, compelling, and well-structured that it makes the reviewer’s job easier and your project more successful.
Final Thoughts
Technical writing in the life sciences isn’t just about accuracy—it’s about clarity, relevance, and strategy. When you build your document on solid templates, write with the three Cs, stay within scope, and take time to revise, you position yourself as a professional who delivers exceptional value.
That’s the kind of writer people will remember and trust.
For more information regarding the tips and tricks above and even more guidance on technical writing, please listen to Jennifer’s two-part series on GLOBAL’s podcast, Chasing Compliance:
Chasing Compliang_Part 11 and Chasing Compliance_ Part 22.