Technical Writing - Normative Writing - Profit Writing for Medical Writers

Medical writing is a special subset of technical writing that requires familiarity with medical and pharmaceutical terminology. For writers with a background in medicine, chemistry and/or pharmacology, it is a perfect place to write.

In the medical writing sub-set, regulatory writing is another very good profession because your employer is usually a pharmaceutical company with few cash problems.

Regulators prepare documents to ensure approval by government regulators before they can be sold to the general public. In each country, the corresponding regulatory body is different, but in the United States, it is the Food and Drug Administration [FDA].

There are several types of professional documentation that you can be asked to write as a regulatory writer. Here are the two most important ones:

IND [research new drug application] from

 . This document was prepared after testing the experimental animals and after the drug was considered ready for clinical trials in human subjects. The document must include complete data on the drug, including all of its chemical and molecular properties. In addition, it also needs to include test results for laboratory animals. In the United States, pharmaceutical companies must first obtain FDA approval before proceeding. Sometimes approving a new drug can make or break the company. So you can imagine the importance of the IND file.

NDA [new drug application] from

 . This document reports the results of all clinical trials performed on human subjects. NDA must be written in a rigorous, logical style that presents all pharmacology, physiology, and other relevant data in a sequential manner to demonstrate that the drug is safe and readily available for general public use. Since defective drugs can easily lead to class actions, this is another document that should be carefully prepared by regulatory writers who know how to ask the right questions to SMEs [thematic experts] to ensure that all possible questions are answered satisfactorily. .

Regulators also prepare other important documents, such as from

CTD [General Technical Document] from

 with from

MAA [Marketing Authorization Application] from

 .

If you are a technical writer and have an understanding of medicine, biomedicine and pharmacology, I would strongly encourage you to explore this lucrative niche for your future career.

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