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.
The job of the regulatory writer is to secure regulatory approval before a drug can be released to the general market. The regulatory agency in the United States that oversees the whole approval process is the Food and Drug Administration (FDA).
Regulatory writers are responsible for writing a number of specialized documents that are specific to this niche. Here are the two most important of them all:
IND (Investigational New Drug Application). Clinical trials on human subjects cannot begin before this document is prepared following the conclusion of the animal tests. This document is a comprehensive one. It includes all available data on the chemical and molecular properties of the drug in question. Plus, it has to talk about the results of all lab tests with animals. For an American pharmaceutical company to market a drug, it first has to have its IND document approved by the Food and Drug Administration (FDA). Whether a pharmaceutical company will make millions or lose millions all depends on the approval process. Thus the importance of the IND document cannot be overemphasized.
NDA (that is, New Drug Application). This document reports the results of all clinical trials conducted on human subjects. NDA must logically argue and back up its claims with facts to the effect that the new drug can safely be consumed by the general public. Each year some drug companies are sued for providing defective information to the consumer public. To prevent that, regulatory writers interview all the experts and make sure every possible drug-related question is answered in this document.
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.
