Medical writing is a special subset of technical writing that requires familiarity with medical and pharmaceutical terminology. It is the perfect writing niche for writers with a background in medicine, chemistry, and/or pharmacology.

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

Regulatory writers produce the documents to secure approval from government regulatory agencies before a new drug can be marketed for general public use. In each country, the respective regulatory agency differs, but in the United States it is the Food and Drug Administration (FDA).

There are several types of specialized documents that you will be asked to write as a regulatory writer. Here are the two most important of them all:

IND (Investigational New Drug Application). This document is prepared after testing in laboratory animals has been completed and before the drug is considered ready for human clinical trials. The document must include complete data on the drug, including all its chemical and molecular properties. In addition, you must also include the results of tests on laboratory animals. In the United States, a pharmaceutical company must have its IND approved by the FDA before proceeding. Sometimes the approval of a new drug can make or break a company. So you can imagine the importance of the IND document.

NDA (New Drug Application). This document reports the results of all clinical trials conducted in humans. The NDA must be written in a strict logical style, presenting all relevant pharmacological, physiological, and other data in a sequential manner to demonstrate that the drug is safe and ready to be marketed for general public use. Since faulty medicines can easily lead to class action lawsuits, this is another document that needs to be carefully prepared by regulatory writers who know how to ask SMEs (subject matter experts) the right questions to ensure that all possible questions are addressed. answer satisfactorily.

Regulatory writers also prepare other important documents, such as CTD (Common Technical Document) Y MAA (Marketing Authorization Application).

If, as a technical writer, you have any inclination towards medicine, biomedicine and pharmacology, I highly recommend that you explore this lucrative niche for your future career.