What Is Medical Writing?

Great question! Scroll down for more details on this fascinating (to some) and esteemed (to a few) profession.

What is a professional medical writer?

According to the American Medical Writers Association (AMWA) (and they are the experts on this), a medical writer is a professional involved in "the development and production of print or digital documents that deal specifically with medicine or health care."

What do medical writers do?

Professional medical writers write peer‑reviewed articles for publication in journals, create marketing copy, educate health care professionals and general public, write grant proposals, take minutes at meetings and produce reports, and — my favourite — write clinical and regulatory documents so new therapies can be properly investigated and licensed. Phew, that was a long sentence! But wait — professional medical writers are so much more!

Many of us are scientists, pharmacists, nurses, or pharmaceutical industry insiders. Like you, we are professionals dedicated to providing access to innovative treatments.

Great, but what can a medical writer do for me?

That depends on your needs and wants, your budgets and timelines, and who you are speaking with. But more on that in another post (coming soon). In general, when you work with a professional medical writer, you are getting much more than just writing help.

Let's have a look at what experienced medical writers do when they "write":

• Produce clear, concise and scientifically sound materials

• Ensure compliance of your documents with regulatory and industry standards

• Target the writing style to your audience, from technical to plain language

• Maintain consistency in messaging across your documents, platforms, and departments

• Manage and drive the process to ensure timely completion of your project

• Liaise with other professionals, like study investigators, statisticians and CROs

• Provide strategic advice on data positioning and communication

Examples, please!

Happy to oblige. Below is a look at some tasks an experienced medical writer can do for a couple of commonly requested deliverables. Just click on the arrows below for more details.

Clinical Study Report (CSR)

• Provide or follow an ICH-compliant template

• Compile hundreds of pages of raw data into a clean, informative and thorough report

• Write a concise and clear synopsis

• Analytically and critically assess the data

• Identify any issues/outliers in the data and dig deeper to get the details

• Alert you to any issues with compliance

• Liaise with statisticians, CROs, PIs, etc., to clarify any issues

• Work with your regulatory department to ensure timely completion of the project

• Provide informative and readable discussion and conclusions, with references to support the claims

• Thoroughly data-check and proofread the document

• Ensure consistency in reporting with your previous studies

• Troubleshoot any issues along the way

Peer-Reviewed Publication (Manuscript)

• Provide appropriate journal suggestions

• Search for the most up-to-date literature

• Write informative, well-researched and referenced introduction and discussion

• Translate complicated clinical data into easy-to-read and easy-to-understand documents

• Create attractive and informative figures that best feature the data

• Highlight key messages throughout the document

• Thoroughly data-check and proofread the document

• Tactfully communicate with authors to collect their comments, disclosures and acknowledgments

• Ensure compliance with the journal's author guidelines and with best practices in data reporting (e.g. Good Publishing Practice [GPP] guidelines)

• Navigate the publisher's submission portal to submit the manuscript

• Troubleshoot any issues along the way

So how do I get a medical writer to help me?

Easy! You can click here to contact Intellimmune or send an email to info@intellimmunemedcomms.com and tell me what you need help with.

I hope this short intro was useful in helping you get a better understanding of medical writing as a profession.

Stay curious!

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Resources at a glance

• American Medical Writers Association and European Medical Writers Association have great resources for those interested in a career in medical writing as well as a listing of medical writers for those looking to hire a professional medical writer.

• ICH E3 guideline on the Structure and Content of Clinical Study Reports is an invaluable resource for drafting CSRs.

• The recently updated Good Publishing Practice guidelines (GPP2022) are a great resource on producing a manuscript. In fact, the International Society for Medical Publication Professionals (ISMPP) website has many other resources related to scientific medical writing well worth a read.