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.

Copyright 2016  Biotech Ink, LLC  All rights reserved.

About Susan E Caldwell, PhD

Medical writer and author (since 1995), passionate writer (most of my life), PhD scientist (medical microbiology and immunology), lover of music, voracious reader, and eternal optimist.

4 responses »

  1. Sebastian says:


    Excellent piece as usual! I would like to add my 2 cents from my own experience. While I agree that one must have the industry experience in order to ultimately succeed as a contract regulatory medical writer, it is certainly not impossible to _start_ your career transition by freelancing for some time. You can get valuable insights this way, both into the profession, and into your own personality and fitness for this line of work. You just can’t expect to make any significant money by doing this :), so make sure your life situation allows for it (health insurance, savings, back-up plan etc.). It is an especially good way of career transition for medical professionals, because they already have the medical knowledge under their belt, and now need to see if they really feel like writing highly technical texts for a living. We all tend to glamorize our chosen new career in our minds; freelancing, sort of like volunteering, can give us a chance to really see what it is in its mundane day-to-day reality.

    I have done exactly this, and – surprise, surprise – realized that I do need to get the industry experience. The good thing is, I am now able to say with full confidence that I know what I am getting involved in.

    So the industry experience is indeed unavoidable – but then again, if one really likes regulatory writing, why would they want to avoid it? 🙂

    Sebastian Kristof, MD

    • Hi, Sebastian,

      Thanks so much for your kind words and terrific comments. In my article, I didn’t really consider the possibility of doing preliminary freelancing as preparation for a career in freelance regulatory writing, with an interim period in industry between the two periods of freelancing. However, I agree with you that, if done right, it could be a successful approach. You may not make much money at it, but that’s OK–the point is to get those critical first experiences. If you can get a few projects under your belt that qualify as regulatory writing, it would certainly help to put those projects on your resume! In turn, this would open doors for either more freelance work or a permanent position as a medical writer.

      To succeed with this approach, I think it would be very important to charge a low hourly rate relative to the usual rate(s) for regulatory writing, because of the lack of experience. Some companies will find this very attractive and may move forward to hire you because of the medical writing fees it will save them.

      As you noted, you would need to have other sources of financial support during the period of initial freelancing, ensuring that you’ll be able to continue to pay your bills! Having these sources of support is important anyway, though, because freelance or contract regulatory writers do experience periods of little or no work sometimes.

      A cautionary comment about those very early freelance projects: you could find yourself in over your head if you accept a project that you aren’t qualified to work on. When faced with a decision to accept the work, it would be wise to be honest with yourself about whether you can competently do the job. If you feel uncomfortable about this, then you’re better off turning it down. Without this awareness, it would be easy for your desire to get the project to override your good judgment.

      Thank you again for your wise comments and wonderful viewpoint. And best of luck in your new career!

      Warm regards,


  2. Sakshi Singh says:


    I applied for the position of medical editor in a company. I was given an editing test for that. I completed the test and sent them. But I got a negative response from them. I think I did fairly well on that and wanted to get it reviewed by you. It’s a one page test and should not take much time to review it.

    I will grateful to you if you can help me here.


Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s