Medical writing is a special subset of technical writing that requires familiarity with medical and pharmaceutical terminology. It is an excellent niche for those writers with a scientific background.

And within the medical writing subset, regulatory writing is another specialty that pays very well since your employers are usually pharmaceutical companies that rarely have any cash problems.

Regulatory writers generate all the relevant documents required to secure approval for all new pharmaceuticals. In the United States, the Food and Drug Administration (FDA) is responsible for regulating all drugs.

This special writing niche requires a regulatory writer produce a set of very specialized documents. Here are the two most important of them all:

IND (Investigational New Drug Application). The tests are concluded on the lab animals first. And then, and before the same is tested on any human subjects, this document is written by regulatory writers. All the crucial information about the chemical and molecular properties and characteristics of the drug are expected to be included in this document. Plus, all the results of the tests with animals must be in there as well. Without securing the approval of the IND document from the FDA no American drug company can market anything in the United States. Some companies sometimes go bankrupt when their drugs are not approved. That’s why IND document is an important one.

NDA (that is, New Drug Application). The results of all clinical trials conducted on human subjects are included in this document. NDA must be written in a tight logical style, presenting all the pharmacological, physiological and other pertinent data in a sequential manner to prove that the drug is safe and ready to be marketed for general public use. One of the important responsibilities of a regulatory writer is to make sure to questions are left unanswered and that the pharmaceutical company is protected against any lawsuits that may arise due to lack of appropriate information.

Regulatory writers prepare other important documents as well, like CTD (Common Technical Document) and MAA (Marketing Authorization Application).

If as a technical writer you have any leanings towards medicine, biomedicine, and pharmacology, I’d strongly encourage you to explore this lucrative niche for your future career.