What Do Regulatory Writers Do?

This is a question I am asked a lot. Even people who hire freelance regulatory writers do not always have a clear idea on what to expect. It is true that the experience and expertise among regulatory writers can be vastly different. Some can do a, b, c, and d, but not e and f; others can do a, c, d, and f, but not b and e. For example, I can write INDs, clinical summaries, and CSRs, among other things. However, when I was asked to design a CRF (case report form), I politely declined. I know how to read a CRF and even edit it once in a while, but I have neither the expertise nor the appropriate tools to design one from scratch.

Nevertheless, a regulatory writer, especially a freelance one, has to do some different types of work besides merely typing up new words. Below are only a few examples of what I may do within a span of an average week:

1. Persuade the client to let me use one space, rather than 2 spaces, after a period in their documents. (A quick search on the Internet would show that the antiquated practice of 2 spaces after a period has been abandoned by modern style manuals.)
2. Format several submission documents to a foreign regulatory health authority, so that they all look clean, consistent, and professional.
3. Revise a protocol because the study team has decided to add an endpoint, and then go through the entire protocol to make sure that relevant information is added to all the relevant sections.
   
4. Review a statistical analysis plan and identify inconsistencies with the protocol. Suggest to the team that the protocol should be amended.
   

A regulatory writer does not just write. Far from it. Even after a decade in this line of work, I occasionally still feel dizzy with the rapid gear shifts from one moment to the next, from the most minute details to strategic questions that could affect the success of a clinical trial.