Because I keep getting asked this question, I’m going to address it very directly in this post. I know there are many folks who want to do regulatory writing, but they don’t want to have to get a job in the drug industry to accomplish this goal. For those of you who have medical backgrounds, in particular, I certainly understand your position.
However, becoming a successful freelance (contract) medical writer is extremely difficult, if not impossible, without industry experience.
It gets down to this: you can’t write well about something you don’t understand, and you must have a reasonably thorough understanding of the drug/biologic development process in order to write clinical and regulatory documents about it. (I’ve covered this issue in more detail in my article, “What It Takes to Be a Medical Writer”.)
In the future, there may be numerous books that can teach you the things you learn when you work in the drug industry, but as of now, I’m not aware of any that can deliver that kind of knowledge. It’s also unlikely that a prospective employer will hire you if they see you’ve never worked in the industry and never written the documents that they need help with (eg, investigator brochures, study protocols, clinical study reports, amendments, annual reports, INDs, NDAs, and BLAs). Those documents are almost always written by in-house writers or *experienced* contract writers. Why? It’s actually simple. Those documents are too important to the company’s success to trust them to a writer who can’t show that they already know how to write them.
Drug companies spend a great deal of money to do preclinical research and clinical testing of their candidate drug products. This is what the company is all about, and the ultimate goal is to get the drug approved for commercial sale. To get the drug approved, the company does its research and then prepares an NDA (New Drug Application) or BLA (Biologic License Application) that summarizes literally everything that is known about the drug (by the company or any other source). This NDA or BLA, a full regulatory submission, requires many months and many people to write, review, format, and prepare for delivery at the offices of the FDA or other regulatory agencies. Often, the future wellbeing of the company depends on whether or not the drug is approved on the basis of that submission.
The writing of the submission, therefore, is a big responsibility. The regulatory writer has a major role in developing the full regulatory submission when the drug is ready to be considered for approval. This pivotal position requires a regulatory writer who has a good understanding of the drug development process, because that’s what the documents are all about. It also requires a writer who understands medical concepts and medical research terms, and who knows the requirements of ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). The principles of ICH must be applied when writing and formatting regulatory documents.
The job of a regulatory writer is very technical and requires the application of medical and legal knowledge. Working in a related position (eg, drug safety, medical writing, or clinical research) in the highly regulated biopharmaceutical industry is an education in itself, and it is excellent preparation for a career in regulatory medical writing. For those who want to transition into regulatory writing, there are many routes from which it can be done, but experience in the drug industry is a firm foundation for which there is just no substitute.
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