Writing For Your Audience–The Forgotten Cardinal Rule

Posted by gcuppan

January 25, 2010

Drug and medical device development is a content-rich world in which regulatory expectations and business trends have escalated the importance of effective development reports and regulatory submissions. The audience for these documents—or any piece of writing for that matter—is the intended or potential reader or readers. In this instance, it is the regulatory reader. For all writers or contributing authors working in this environment, understanding your audience and what they “do” with your documents should be the most important consideration in planning, writing, and reviewing of development reports or submission documents.

After all, the cardinal rule for very good writers is to know their audience and adjust their writing to meet the purpose of the document as well as the needs and background of their principal readers. I am pretty sure this is a forgotten rule for many authors working in the pharmaceutical and medical device industries.

I find it intriguing that if you do a web search on terms such as “writing for the regulatory reader” and “writing to the FDA,” you end up with few useful citations. I have written several posts regarding what we know about how regulatory readers read. What Do You Know about Making a Document Readable and Usable? and Designing Documents for the Regulatory Reader are two that cover the topic in some depth and these appear at the top of the web search list, but there is little else of substance.

Equally intriguing is when I am at my clients and ask authors or subject experts who they consider the principal audiences for their writing, nearly half either fail to offer a response or admit they have not thought about the audience. I am convinced that the vast majority of report authors in the pharmaceutical and medical device industries write for themselves or their immediate supervisor. But, then again, this should not come as a surprise given how little information or guidance is available to writers regarding audience.

Writing in the Life Sciences

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