How Many Languages Does The U.S Use For Government Documents Technical Writing – Regulatory Writing – A Lucrative Writing Niche For Medical Writers

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

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, chemical and/or pharmacological background.

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

Regulatory writers produce 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 is different, but in the United States it is the Food and Drug Administration (FDA).

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

IND (Investigative New Drug Application). This document is prepared after the tests on laboratory animals are concluded and before the drug is considered ready for clinical trials on human subjects. The document must include complete data on the drug, including all its chemical and molecular properties. In addition, we 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 further. Sometimes the approval of a new drug can make or break a company. So you can imagine the importance of IND document.

NDA (New Drug Application). This document reports the results of all clinical trials conducted on human subjects. The NDA must be written in a strict logical style, presenting all pharmacological, physiological and other relevant 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 must be prepared carefully, by regulatory writers who know how to ask the right questions to SMEs (Subject Matter Experts) to ensure that all possible questions are answered satisfactorily.

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

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

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