





































 V38 N4 / 2023 

©2023 American Medical Writers Association. All rights reserved.  
ISSN 2163-5315

AMWAJournal.org     31

ABSTRACT 
In 2021, an American Medical Writers Association (AMWA) 
working group conducted a survey to gain an understanding 
of how regulatory agencies perceive the value of medical writ-
ing. The survey showed that document quality is extremely 
important to the timely and efficient review of an application 
and identified key factors affecting document quality that 
negatively impact application approval. In response to this, a 
working group ran a series of roundtables at the AMWA and 
European Medical Writers Association conferences to gather 
opinions from medical writers about this survey and how we 
can best communicate these ideas to authoring teams. This 
article discusses the feedback obtained in those roundtable 
sessions and presents the working group’s proposal for a set of 
resources to empower medical writers to implement change. 

INTRODUCTION
Medical writers bring value across the health sciences, 
driving efficient approaches for the delivery of high-qual-
ity medical communication documents targeted at diverse 
audiences including regulators, payors, physicians, and 
patients.1–3 The results of the American Medical Writers 
Association (AMWA) 2021 regulators survey3 demonstrated 
that regulatory reviewers recognize the value of medical 
writers in the preparation of regulatory documents submit-
ted to obtain new drug approvals worldwide. Of the regula-
tors surveyed, 70% agreed or strongly agreed that medical 
writers improve the quality of documents, and 87% agreed 
or strongly agreed that sponsor companies with established 
medical writing functions and rigorous document develop-
ment processes and standards produce higher quality sub-
missions. Importantly, 87% confirmed that poor document 
quality impedes regulatory assessment, and 77% of the reg-
ulatory reviewers agreed or strongly agreed that poor docu-
ment quality delays the approval process.

 Thus, the impact of poorly written documents can be 
substantial. The survey showed that poor document quality 
negatively affects the applicant’s goals, which in most cases 
would be the approval of a drug or expansion of indication. 
When the regulators were asked which one document qual-
ity issue they encounter most frequently, the 3 top answers 
were excessive length/repetition/verbosity, poor explana-
tion of rationale, and nonadherence to guidance. These are 
all things that medical writers can have a direct impact on 
if their authoring teams agree to using common ideas con-
sidered to be good medical writing practice (eg, lean writing 
and effective review processes).
 The current working group was formed to educate  
medical writers about the importance of these regula-
tor-conveyed issues with document quality and to empower 
writers by proposing evidence-based resources they can use 
to advise and convince their authoring teams about what 
good medical writing practice is and why it is essential for 
successful regulatory documents. 

EDUCATING AND EMPOWERING MEDICAL WRITERS 
The survey revealed that regulatory reviewers appreciated 
and recognized the contributions and value of trained  
medical writers. The AMWA Value of Medical Writing work-
stream focusing on the regulator’s perspective concluded 
that “Training must equip medical writers to lead teams 
that create documents that are concise and clearly pres-
ent the messages supported by the data.”4 Moreover, recog-
nizing the regulator’s appreciation for the medical writer’s 
contribution is a powerful tool to guide the industry toward 
more streamlined writing practices that will ultimately aid 
and streamline drug approvals. Making the writing commu-
nity and their teams aware of this feedback should be a  
priority for the profession.

Lisa Chamberlain James,1 Julia Forjanic Klapproth,2 Rona Claire Grunspan,3 Wayne Beazley,4 Brian Bass,5 Joan Affleck,6 
Julia Cooper,7 Caroline Lilley,8 and Amy Wollish9 / 1Trilogy Writing and Consulting, Cambridge, UK; 2Trilogy Writing and 
Consulting, Frankfurt, Germany; 3Medical Writing, ICON plc, Leawood, KS; 4Medical Writing, Astellas, Northbrook, IL; 
5Bass Global Inc, Fort Myers, FL; 6Medical Writing, Merck and Co, Inc, Rahway, NJ; 7Global Medical Writing Services, 
Parexel International (IRL) Limited, Dublin, Ireland; 8Regulatory Writing, Amgen, Thousand Oaks, CA; 9Medical Writing, 
Jazz Pharmaceuticals, Palo Alto, CA

Value of Medical Writing—Using the Regulator’s Perspective  
(2021 Survey Results) to Educate and Empower Medical Writers 

TOPICAL FEATURE

http://www.amwajournal.org


AMWAJournal.org     32Using the Regulator’s Perspective to Educate and Empower Medical Writers 

 To this end, the data from the AMWA Value of Medical 
Writing workstream were presented at roundtable sessions 
at the European Medical Writers Association conference in 
May 2022 and the AMWA conference in November 2022. 
The medical writers who participated in the roundtables 
were informally surveyed to assess what their opinions were 
about the survey results. We also sought their input on how 
they thought a set of resources would help to implement 
change in the specific areas of improvement identified and 
what they felt would be useful to include in such a set. The 
feedback from these sessions was formative for develop-
ing the concept of the set of resources to help implement 
change. The key ideas are summarized below. 
 First and foremost, it was recognized that the medical 
writing community needs to be made more aware of the 2021 
article. Of approximately 20 medical writers who attended 
the roundtable sessions, only 2 had read the article and were 
aware of it prior to the session. This made it clear that there 
is a very low awareness of the article among medical writers. 
There was general consensus that, for people to actively use a 
set of resources based on the data from the article, they need 
to be well-versed in the upstream survey and results.
 Beyond that, we asked for input on what participants 
felt a set of resources should be to aid in educating their 
teams. Based on the responses, it was understood that  
the resources should provide material to help medical  
writers understand and raise awareness about the following 
key topics: 

• Having a clear, strategic presentation of rationale
• Streamlining the writing process
• Demonstrating value for management from using 

good medical writing practices

 To help teams understand the need and methodol-
ogy for a clear, strategic presentation of rationale, the set of 
resources should

• provide examples and arguments for explaining the 
rationale for study design and in-text data selection,

• present arguments for having the medical writer 
actively participate in kickoff and strategy meetings 
and lead comment resolution meetings, and

• describe and explain how professional reviewers 
review documents.

 To help with streamlining the writing process, the set of 
resources should

• present arguments that a medical writer can share 
with their team to support the use of lean writing and 
demonstrate that it is not necessary to repeat all the 
data in text (eg, the regulators clearly expressed a pref-
erence for lean and concise writing; lean writing needs 
less quality control time),

• contain examples of what non-lean writing looks 
like compared with lean writing and include simple 
examples of how streamlining the language can be 
achieved, and

• provide a list of good writing practices based on the 
results.

 To demonstrate value for management, the set of 
resources should provide arguments that can be used to 
convince management of the importance of well-written, 
lean documents. In addition, the participants of the round-
table sessions felt that the set of resources should be useable 
for training medical writers and include visual aids that can 
be embedded in other materials.
 Ultimately, the goals of the set of resources are to raise 
awareness and highlight the importance of

• delivering succinct documents with clear and concise 
reporting of results and messaging,

• educating teams on how professional reviewers review 
documents, and

• empowering medical writers to act as strategists and 
key drivers of their documents.

 The topics associated with these goals are outlined in 
Table 1 on the next page. Based on this, a set of resources 
will be created comprising a set of documents and slides 
that can be used with different audiences, depending on the 
setting and document types.
 We hope that disseminating this set of resources will help 
spread the important message of the regulators survey and 
give medical writers effective arguments to show their teams 
that by applying good medical writing practice to reduce 
length/repetition/verbosity, increase clarity, and provide a 
better explanation of rationale, we can accelerate the drug 
approval process and deliver medicines to patients faster.

Author declaration and disclosures: The authors note no  
commercial associations that may pose a conflict of interest in 
relation to this article. The opinions expressed in this article  
are the authors’ own and are not necessarily shared by their 
employers or AMWA.

Author contact: Lisa@trilogywriting.com

References
1.   Marchington JM, Burd GP. Author attitudes to professional medical 

writing support. Curr Med Res Opin. 2014;30(10):2103-2108.
2.   Forjanic Klapproth J. Strategic medical writing: why settle for less. 

Pharm Phys. 2012;22(6):20-24.
3.   Limaye N. Medical writing: the language and art of scientific 

communication. Global Forum. Published 2020. Accessed 
October 4, 2023. https://globalforum.diaglobal.org/issue/
may-2020/medical-writing-the-language-and-art-of-scientific-
communication/

4.   Cooper J, Chamberlain James L, Affleck J, Bass B, Forjanic 
Klapproth J, Harris D. Value of medical writing: the regulator’s 
perspective. AMWA J. 2021;36(4):145-151. 

http://www.amwajournal.org
https://globalforum.diaglobal.org/issue/may-2020/medical-writing-the-language-and-art-of-scientific-communication/
https://globalforum.diaglobal.org/issue/may-2020/medical-writing-the-language-and-art-of-scientific-communication/
https://globalforum.diaglobal.org/issue/may-2020/medical-writing-the-language-and-art-of-scientific-communication/


AMWAJournal.org     33Using the Regulator’s Perspective to Educate and Empower Medical Writers 

Table 1. Goals and Topics of the Resources Set for Medical Writers

Goals of the Resources Set Resources Set Topics
Delivering succinct documents with  
clear and concise reporting of results  
and messaging

Good writing practices 
How to avoid poor explanation of rationale and unclear key messaging
Removing repetition: give examples
Increasing the use of cross-referencing both within and between documents
Using succinct bulleted lists or tables to convey key information, as appropriate, 
instead of long paragraphs
Contemporary abbreviation rules (not defining at first use: explain how this saves 
time in multiple areas)
Reducing excessive length
The value of using a single template for study reports and other documents  
(for uniform structure and data presentation)

Educating teams on how professional 
reviewers review documents

If time is of the essence, what should the team focus on first to ensure the  
document will help them easily find the answers to the questions they  
have—what are the key messages, and have we made sure a reviewer sees these 
in each section? 
Help teams understand the importance of effective cross-referencing to  
guide reviewers to supporting information. 
Giving the assessors the messages in succinct text that aids them to prepare their 
assessment reports. If they do not have to slog through writing those reports 
from scratch and can copy over well-written text that has clear messages, it can 
save days of time in completing the assessment.

Empowering medical writers to act  
as strategists and key drivers of their 
documents

MW is present at kickoff and strategy meetings so they properly understand 
the rationale behind the messaging: only in this way can they effectively 
communicate the message.
MW should lead the comment resolution meetings—they know best where the 
unanswered questions are in the document and where there are gaps that  
need filling.
MW should be proactive in referring to relevant guidances, agency websites, and 
primary source references to tailor and suggest text within the dossier.
Provide a strong argument for explaining the rationale for selection of the data.
The MW should have a clear vision of how the data work together to build the 
overall story—and should advise the team on optimal ways of presenting these 
data (in figures, tables, text) to best communicate the flow of logic that leads to 
the conclusions.
Clarification of roles on teams: no one person owns the content of a document; 
there is a team of authors who all contribute to a document. Yet, the medical 
writer owns the master version of the file and is responsible for making sure 
comments are all addressed and applied consistently throughout. There cannot 
be a free-for-all, or the MW will lose oversight of document integrity and what 
has been changed. 

 MW, medical writer.

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