





































 V37 N4 / 2022 

©2022 American Medical Writers Association. All rights reserved.  
ISSN 2163-5315

AMWAJournal.org     23

Of all the points in the evolution of the medical writing pro-

fession, I believe we are at the pinnacle of what promises to 

be the most exciting and biggest paradigm shift in medical 

writers’ roles and responsibilities. With an accompanying 

leap in the introduction and use of technology in ways we 

have only dreamt of until now, this is a huge opportunity 

for all of us. However, it will also require medical writers to 

expand and hone their already extensive skill sets, and for 

their managers to embrace new technology and empower 

their teams to really grow and flourish into their new roles. 

For those forward-thinking companies, the rewards—

including increased job satisfaction, faster and more effec-

tive submissions and approvals, increased general public 

engagement, and productivity from their teams—promise to 

be significant.

GLOBALIZATION OF MEDICAL WRITING
Collaboration Among Professional Organizations
Collaboration and harmonization have to be the key aims 

and the buzz words for this next phase of medical writ-

ing evolution. Each region doing slightly different things 

in slightly different ways is not only inefficient, but ripe for 

increased human error. There is an increasing demand for 

more and better medicines and information delivered more 

quickly to patients and the general public, and, coupled 

with a lack of highly trained medical writing professionals, 

the only way to meet this demand is to collaborate and har-

monize as much as possible. This plea extends not only for 

collaboration and harmonization among professional orga-

nizations, but among regulatory agencies. Let’s take one 

document—the Clinical Study Report (CSR)—as an exam-

ple: imagine a utopian situation in which all CSRs were 

written and data were presented in the same way. Not only 

would these documents be much easier and quicker to pro-

duce and review, but much of the first draft at least could be 

automated, freeing medical writers to focus on their higher 

value skills of discussing key messages and key data points 

with their clinical and regulatory teams, and honing and 

crafting the final documents to be the concise and accurate 

representations of data that currently can take months to 

prepare (see comments on the shared technology question).

 Harmonization of document templates and guidelines 

could also positively impact the dearth of skilled medical 

writers. Not only could they leverage their knowledge and 

experience more easily between regions, but it would open 

up more career opportunities for them geographically, 

making the profession more attractive and increasing reten-

tion of talent.

Defining the Profession Along Agreed Lines 
With collaboration and harmonization across the industry 

come the added benefits of common training and educa-

tional aims and needs. This would allow certification sys-

tems to be put into place with meaningful outcomes and 

measurements and allow and encourage medical writers to 

expand their skill sets to meet the growing demands of the 

profession without relying solely on an individual compa-

ny’s commitment to and expertise in their training.

Expansion to Other Professional Associations/
Professions With Venn Diagram Overlap 
Of course, the benefits of harmonization extend beyond 

the medical writing sphere. There are many areas of over-

lap with organizations such as SCOPE, the International 

Committee of Medical Journal Editors, TransCelerate, and 

the Patient Information Forum. If the medical writing com-

munity can engage and collaborate more with these orga-

nizations, we can pool resources and knowledge and make 

a much larger impact on the guidelines and templates and 

information available to the general public. Such organi-

zations could also potentially contribute to aspects of any 

certification schemes for medical writing, bringing their 

specialist knowledge of their areas and offering specialist 

training opportunities. This can only benefit medical writers 

and the profession as a whole.

Shared Technology 
There is no doubt that the industry is ripe for an explosion 

Lisa Chamberlain James, PhD / Senior Partner, Trilogy Writing & Consulting, Cambridge, England

The Future of Medical Writing: A Panel of One 

THEME ARTICLE

http://www.amwajournal.org


AMWAJournal.org     24The Future of Medical Writing: A Panel of One 

of shared and new technology, including etemplates, virtual 

and real time clinical trials, etc. TransCelerate has already 

made huge strides in producing and making freely available 

some excellent templates for medical writers to use, which 

will hopefully encourage harmonization of documents 

across the industry. Beyond that, software and technologi-

cal advances are already taking shape, and regulatory agen-

cies are preparing themselves (the United Kingdom has 

proposed a new pro-innovation framework1 for regulating 

artificial intelligence). Some initial offerings have been in 

place for several years now, and these are being expanded 

with new technologies to automate initial drafts, bringing 

the benefits and advantages already mentioned.

Common Lexicons 
The general public are increasingly demanding more under-

standable and better information about their medicines 

and therapies. This is essential not only to engage the public 

in clinical development, but to help them better use their 

medicines. If we are truly to ask the general public to be 

involved in the decision making about their treatment or 

involvement in trials or in any stage of clinical development, 

we must clearly explain the benefits and potential harms, 

along with the context surrounding the need for the treat-

ment, therapy, or intervention.

 However, it is an extremely difficult and highly skilled 

task to convert complex clinical and medical information 

into plain language. The first step is to find suitable vocabu-

lary! Excellent and ground-breaking work has already been 

done by organizations such as the Clinical Data Interchange 

Standards Consortium and the Multi-Regional Clinical 

Trials Plain Language Glossary Group. A common lexicon is 

essential to be able to communicate with the general public 

to reduce the confusion created when different wording is 

used to explain the same disease or procedure. Sharing the 

lexicons and making them freely available is a huge service 

not only to the medical writing profession but to the general 

public as a whole, and the continuation and expansion of 

these initiatives will allow medical writers to connect with 

audiences that have been out of reach for them until now.

Author declaration and disclosures: The author notes no  
commercial associations that may pose a conflict of interest in 
relation to this article.

Author contact: Lisa@trilogywriting.com

Reference
1.  Mulryne J, Schildkraut PJ. UK proposes new pro-innovation 

framework for regulating AI. Arnold & Porter website. 
Published July 26, 2022. Accessed October 14, 2022. https://
www.arnoldporter.com/en/perspectives/blogs/enforcement-
edge/2022/07/uk-proposes-framework-for-regulating-ai

BIOSUMMARY
Lisa Chamberlain James, PhD, is a senior partner and CEO 

of Trilogy Writing & Consulting. Aside from management 

activities, she leads client projects with extensive experi-

ence in a variety of documents. Lisa has a special interest in 

writing for the public and in patient information. Following 

a PhD and post doctorate in Pathology at Cambridge, Lisa 

began her medical writing career in 2000. Since then, she 

has been involved in EMWA as a member of the Educational 

Committee, as a mentor, leader, and assessor of work-

shops, and teaches and reviews workshops for AMWA. Lisa 

holds an EMWA professional development certificate, is a 

member of TOPRA, DIA, and PIPA, initiated and chaired the 

EMWA Pharmacovigilance and Communicating with the 

Public Special Interest Groups, and is also chair of the  

Geoff Hall Scholarship Committee, section editor of the 

“Medical Communications and Writing for the Public”  

section of Medical Writing, and a Fellow of the Royal Society 

of Medicine.

http://www.amwajournal.org
https://www.arnoldporter.com/en/perspectives/blogs/enforcement-edge/2022/07/uk-proposes-framework-for-regulating-ai
https://www.arnoldporter.com/en/perspectives/blogs/enforcement-edge/2022/07/uk-proposes-framework-for-regulating-ai
https://www.arnoldporter.com/en/perspectives/blogs/enforcement-edge/2022/07/uk-proposes-framework-for-regulating-ai



