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


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

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

Regulatory writers produce documents to obtain approval from government regulators before a new drug is placed on the market. In each country, the regulatory body concerned differs, but in the United States it is the Food and Drug Administration (FDA).

There are several types of specialized papers that you would be asked to write as a regulatory drafter. Here are the two most important of all:

IND (new research drug application). This document is prepared after the conclusion of the laboratory animal tests and before the drug is considered ready for clinical trials in human subjects. The document must include complete data on the drug, including all its chemical and molecular properties. In addition, it must also include test results 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 business. So you can imagine the importance of the IND document.

NDA (New Drug Application). This document presents the results of all clinical trials in human subjects. The NDA must be written in a narrow 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 to the general public. Since defective drugs can easily give rise to class actions, this is another document that needs to be carefully prepared by the drafters of regulations who know how to ask the right questions to SMEs (experts in this matter) to ensure that all possible questions are answered satisfactorily.

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

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


  1. You could definitely see your expertise in the work you write. The world hopes for even more passionate writers like you who are not afraid to say how they believe. Always follow your heart.


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