Medical writing is a special subset of technical writing that requires familiarity with medical and pharmaceutical terminology. It is a highly recommended writing niche for those with a head for numbers, formulas and general science.
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 generate all the relevant documents required to secure approval for all new pharmaceuticals. The regulatory agency in the United States that oversees the whole approval process is the Food and Drug Administration (FDA).
Technical writers who specialize in regulatory writing learn how to generate a specific set of specialized documents. Here are the two most important of them all:
IND (Investigational New Drug Application). Regulatory writers prepare this document in between the conclusion of the lab animals tests and the onset of the trial tests on human subjects. This document is a comprehensive one. It includes all available data on the chemical and molecular properties of the drug in question. In addition, it has to reflect the results of the tests conducted in the lab with test animals. All pharmaceutical companies operating in the U.S. market must submit an IND document to the Food and Drug Administration (FDA). Until the IND document is approved the drug company cannot market anything. Some companies sometimes go bankrupt when their drugs are not approved. Thus we hope the importance of the IND document is clear.
NDS (which stands for New Drug Application). This document reports the results of all clinical trials conducted on human subjects. Before the drug can be approved for the general market, the NDA document needs to be written well and convince the approval agency that the new drug is safe, delivers all the physiological, and pharmacological benefits it claims to deliver, and all that is based on sound and scientific laboratory data. Unless the regulatory writers prepare this document carefully, by answering all possible questions, the company can get hit by a massive lawsuit.
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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