400 pages of regulation, 300 pages of novel
I work in pharmaceutical regulatory affairs in Basel, which means I review documentation that determines whether drugs reach the market. The EU framework for clinical trial authorization is approximately 400 pages long and I know it well enough that I have opinions about the paragraph numbering. I've been writing a thriller for two years that is set entirely within a regulatory review process. The protagonist is a reviewer, not a doctor or a detective, and the antagonist is a submission that is technically compliant and factually misleading and the question is how far inside the framework you have to go to find it. My colleagues think this sounds like more work. It is the opposite of more work. I live near the St. Alban neighbourhood and I write on weekday evenings after I've put the regulatory thinking away. The novel is deliberately accurate about the process, because the tension is entirely procedural, and the procedural accuracy is the thing I bring that a novelist without my background wouldn't. I'm not going to name the drug compound in the book because naming it would close off the story too early. That said, anyone who reads EMA guidance documents would recognise the architecture.