A Medical Writing Specialty that Can Put a Lot of Money in Your Pocket – Regulatory Writing
Medical writing is a special subset of technical writing that requires familiarity with medical and pharmaceutical terminology. It is one of the best and highest-paying writing jobs available today for those who enjoy to read and write about 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.
To create the appropriate documentation in order to obtain regulatory agency approval for a new drug is the chief responsibility of a regulatory writer. The Food and Drug Administration (FDA) is the powerful government agency that regulates drugs in the United States.
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 also has to include the results of lab tests with 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. The fate of a pharmaceutical company usually hangs in the balance of the approval process. That explains the importance of the IND document.
NDS (which stands for New Drug Application). The results of all clinical trials conducted on human subjects are included in this document. 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. Each year some drug companies are sued for providing defective information to the consumer public. To prevent that, regulatory writers interview all the experts and make sure every possible drug-related question is answered in this document.
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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