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Who Hires Regulatory Medical Writers?

September 14, 2016 | Jacquie Powell, PhD, Clinical Research Scientist II | Medical Writing Services

Towards the end of my postdoc, as I started to reach out to local regulatory medical writers, it seemed that everyone in the field had a convoluted story about how they ended up in the field. While it was interesting to hear their stories, it was discouraging too, because it was tough to know how to position myself.

Here are a few things I learned along the way about how to break into regulatory medical writing and who hires regulatory medical writers.

How to break into regulatory medical writing

cliff Regulatory medical writing isn’t something that most people learn about while they’re in school, so most people feel lucky to have stumbled upon it.

Perhaps in part because there is no standard training for regulatory medical writers, there also doesn’t happen to be a “standard” job title.

While some companies may call their regulatory medical writers “medical writers” others may call them “clinical research scientists” or “regulatory writers” and others may call them something different altogether.

Image courtesy of watiporn at

This ambiguity means that you will have to get to know the job market in your area.

So my advice is to: Network, network, and then network some more. (Stay tuned for our upcoming blog series on how to do just that.)

Almost everyone I’ve met landed their first job because they happened to meet the right person who was willing to take a chance on them. So, don’t be shy!

Who hires regulatory medical writers?

Alright, so what kinds of companies are interested in hiring regulatory writers? Well, there are two main types of employers:

  • Pharmaceutical companies

Pharmaceutical companies are responsible for developing new pharmaceuticals for use as medications.

Typically, regulatory medical writers employed by pharmaceutical companies are responsible for writing documents related to one (or maybe more) drugs at any given time over the course of the drug’s development or “lifecycle.”

medsImage courtesy of amenic 181 at

Large pharmaceutical companies tend to have more established processes, with highly defined medical writing responsibilities.

On the flip side, smaller pharmaceutical companies may expect/allow regulatory medical writers to take on many different responsibilities, including project management and/or quality control.

  • Contract research organizations (CROs)

Because each step in the drug development process is complex, many pharmaceutical companies find it efficient to rely on a variety of subject-matter experts to navigate the different steps in this process.

So, instead of managing all of these different types of professionals internally, pharmaceutical companies often outsource research-related activities (including medical writing) to CROs.

Many regulatory medical writers work for CROs, where they are contracted to write a wide variety of documents, across multiple therapeutic areas, for many different types of clients. A CRO tends to provide a fast-paced working environment, filled with learning opportunities.

Working on your own?

Because there are so many home-based positions advertised for regulatory medical writers on social media sites like LinkedIn, many prospective medical writers envision the autonomy of an at-home or freelance medical writing career.

While this may be an attractive option for an experienced medical writer, don’t underestimate the value of learning from experienced co-workers (particularly when you’re new to the field).

A good employer will have a vested interest in your career development and will provide resources and learning opportunities that are vital to your long-term success.

There’s tremendous value in working with a team of experienced professionals, so don’t miss out!

Image courtesy of photostock at


We hope you’ve found this information on regulatory medical writing helpful! By now you should have a firm grasp of what regulatory medical writing is, what regulatory writers do each day, the skills needed, and where to find a job. Not too shabby, eh?

Next up – we’ll talk about non-regulatory medical writing, followed by a separate blog series about local resources available for transitioning into medical writing. This is a must-read for folks in the Research Triangle Park area!

If you have any questions about anything you’ve read, please don’t hesitate to contact us. We’d love to hear from you!

Category: Medical Writing Services,
Keywords: medical writing, regulatory medical writing, medical writer, regulatory medical writer

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