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…
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