Technical Writing – Regulatory Writing – A Lucrative Writing Niche For Medical Writers

Nancy B. Alston

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 medical, chemistry and/or pharmacology 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 produce the documents to secure the approval of the government’s regulatory agencies before a new drug can be marketed for general public use. In every 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’d 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 the tests on laboratory animals are concluded and before the drug is considered to be ready for clinical trials on human subjects. The document must include complete data on the drug, including all its chemical and molecular properties. Plus, it also needs to include the results of the testing on lab animals. In the United States, a pharmaceutical company must have its IND approved by the FDA before proceeding any further. 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 on human subjects. 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. Since defective drugs can easily lead to class-action lawsuits, this is another document that should be prepared carefully, by regulatory writers who know how to ask the right questions to SMEs (Subject matter Experts) to make sure all possible questions are answered satisfactorily.

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.

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