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ABSTRACT 

In 2020, the American Medical Writers Association estab-

lished a working group to assess the value of the contribution 

of medical writers across the health sciences industry, includ-

ing a subgroup tasked to gather data on the regulatory agen-

cy’s perspective. We invited reviewers at regulatory agencies 

to participate in an anonymized survey to evaluate the effect 

of document quality on the regulatory review process, assess 

awareness among document reviewers of the contribution of 

medical writers to the quality of regulatory documents, and 

identify current strengths and opportunities to optimize docu-

ment quality. This article shares the survey results and dis-

cusses their implications for document quality, their impact 

on the regulatory review process, and the skills medical writers 

need to develop to bring value to this process.

INTRODUCTION
Medical writers bring value across the health sciences, taking 

the lead and driving efficient approaches for the delivery of 

high-quality medical communication documents targeted at 

diverse audiences including regulators, payors, physicians, and 

patients.1,2 However, the value of medical writing is not con-

sistently recognized, and medical writers often still need to 

justify why they should have a seat at the table and be part of 

the team earlier in the process. Medical writing departments 

can also be faced with insufficient budget and resource to do 

their best work due to a lack of understanding of the role’s 

value. Given the many settings in which medical writers work 

and the variety of documents produced, it can be challenging 

to identify specific indicators of value. To address this issue, 

the American Medical Writers Association (AMWA) Executives 

Advisory Council established a taskforce to define and quantify 

the value of medical writing. The taskforce has 3 main areas of 

focus: (1) perceptions of medical writer value among medical 

writers and their employers, (2) key topics related to medical 

writer value, and (3) how the regulatory agencies view docu-

ment quality and the value of medical writing.

 This article presents the work of the regulatory agency sub-

group to evaluate the effect of document quality on the regu-

latory review process and assess awareness among regulatory 

agency reviewers of the contribution of medical writers to the 

quality of regulatory documents. By understanding the regula-

tor’s perspective, we hoped to demonstrate how medical writ-

ers bring value to documents submitted to regulatory agencies, 

to identify and refine the training needs of medical writers, and 

to identify areas for action for the medical writing profession 

and for colleagues in the biopharmaceutical industry.

SURVEY DESIGN AND OBJECTIVES
We employed an online survey format (SurveyMonkey), 

targeted at participants who were actively responsible for 

document review at a regulatory agency, were managers of 

regulatory agency reviewers, or who had worked in a regu-

latory agency review role in the past 6 months. Participants 

were eligible regardless of the specific types of documents 

they reviewed. We identified potential participants via con-

tacts in our own networks, via our colleagues (eg, com-

pany regulatory department), and via contacts of the AMWA 

Executives Advisory Council. Participants were also encour-

aged to forward the survey to other eligible individuals within 

their organization. We reached out to the United States Food 

and Drug Administration, Health Canada, the European 

Medicines Agency, the Medicines and Healthcare products 

Regulatory Agency, the Bundesinstitut für Arzneimittel und 

Medizinprodukte, the Pharmaceuticals and Medical Devices 

Julia Cooper,1 Lisa Chamberlain James,2 Joan Affleck,3 Brian Bass,4 Julia Forjanic Klapproth,5  
Dylan Harris6, on behalf of the AMWA Value of Medical Writing Working Group / 1Parexel Interna-
tional, Dublin, Ireland; 2Trilogy Writing and Consulting, Cambridge, UK; 3Merck & Co, Inc, Rahway, NJ, 
USA; 4Bass Global Inc, Fort Myers, FL, USA; 5Trilogy Writing and Consulting, Frankfurt, Germany; 6Takeda 
Pharmaceutical Company Limited, Lexington, MA, USA

Value of Medical Writing: The Regulator’s  
Perspective



146    AMWA Journal / V36 N4 / 2021 / amwa.org        

Agency, the National Medical Products Administration, and 

the Australian Therapeutic Goods Administration, although 

the agencies of those who actually participated are not identi-

fied, as the survey was anonymous. AMWA provided an official 

invitation letter and cover email to explain that the survey was 

being conducted on behalf of AMWA, its objective, and how 

the results will be used and to provide confirmation that the 

responses remain anonymous.

 Being cognizant of limitations on the regulators’ availabil-

ity for such a survey, we made significant effort to develop a 

set of 25 survey questions that we believed would capture key 

points from the regulators’ experience with document qual-

ity and medical writing. Most of the questions were multiple 

choice. The survey also included a checkpoint question to 

eliminate participants not involved in document review, and 

participants were invited to take part in a follow-up inter-

view. For the follow-up interviews, we prepared 7 questions to 

elaborate on the survey results. For example, some questions 

included “none of the above” as a response option. If many 

participants selected this option, we requested additional 

information during the follow-up interviews.

 After beta testing, the survey opened in April 2021 and 

was open through early August 2021. Interim views of the data 

were done in May/June to confirm adequate participation. 

Follow-up interviews were conducted during August 2021.

PARTICIPANT PROFILE
We received 32 responses to the survey. Although this was 

considerably higher than the anticipated response rate, the 

response rate was not uniform across all questions, and it was 

agreed that the sample size was appropriate for descriptive 

analysis only. In the following sections, we have highlighted 

where we believe the data should be interpreted with caution 

due to a lower response rate.

 The data on agency tenure and time spent reviewing docu-

ments indicated that the survey was completed by participants 

meeting the target profile. Most had been employed at their 

current agency for over 5 years (Figure 1) and spent at least 

10% of their time reviewing documents (Figure 2). Participants 

were also asked to indicate their department or division (omit-

ting information that could identify them or their employer). 

Based on these responses, we were reasonably confident that 

we had engaged with the right people at the regulatory agen-

cies for the purpose of this survey.

IMPACT OF QUALITY ON REGULATOR 
ASSESSMENTS
Medical writers will be familiar with how the work of internal 

and client teams is hindered when the documents they are 

given are poorly constructed. The survey results confirmed 

that the work of the regulatory reviewer is similarly impacted if 

documents submitted to the agency are not well written, and 

the responses provide important messages about the value of 

the medical writer. The following section also includes impor-

tant information for colleagues in Regulatory Affairs or other 

functions involved in management of regulatory applications, 

as well as for corporate management.

 The majority (87%) of the participants confirmed that poor 

document quality impedes regulatory assessment (Figure 3). 

Of note, none of the participants disagreed that poor qual-

ity impedes document review, and the remaining 13% had no 

opinion. When asked whether they encounter issues related 

to document quality during the review process, the same per-

centage—87%—reported such issues either sometimes or often 

(Figure 4). These results show that regulatory assessors receive 

poor quality documents for their review relatively frequently, 

and regulatory assessment of the document is thereby impeded.

60%

50%

40%

30%

20%

10%

0% <1 1-5 6-10 11-20 >20
Years

Responses: 32

Figure 1. How long have you been employed at your 
current agency?

Figure 2. In your current position/role, what percentage 
of your time do you spend reviewing documents?

35%

30%

25%

20%

10%

5%

0%

0% 1%-10% 10%-25% 76%-100%26%-50% 51%-75%

Responses: 32



      AMWA Journal / V36 N4 / 2021 / amwa.org    147

 To gauge whether there has been any directional change 

in quality of documents, the regulators were asked how docu-

ment quality has changed in the past 5 years. Improvement 

in document quality was selected by 43% of participants. This 

indicates that the quality of submissions is moving in the right 

direction. However, there is still work to be done, because 

almost half (48%) responded that there has been no change in 

quality or they were neutral/had no opinion, and 9% believed 

that the quality of documents submitted to their agency has 

declined over the past 5 years. Note that at this point in the 

survey the participants had not yet been provided with exam-

ples of quality issues, and so these responses likely reflect the 

regulators’ own concept of document quality.

 If documents within an application are of poor qual-

ity, the regulatory reviewer may need to send the application 

back with questions for clarification. Over half the partici-

pants (53%) said that they send over 10% of applications back 

or reject the application, with questions arising from poor 

document quality (Figure 5). Although 47% of participants 

send back or reject less than 10% of the applications, this still 

means that a sizeable number of applications are delayed. For 

applications that are ultimately approved (Figure 6), 77% of 

the regulatory reviewers agreed or strongly agreed that poor 

document quality will delay the approval process. These are 

clear messages on how poor document quality, which is an 

avoidable issue if proper processes are established and led by 

trained professionals, impacts the applicant’s goals and, per-

haps of more serious consequence, leads to patients waiting 

longer than necessary for new medicines.

 To understand whether poor quality might impact other 

documents in the regulatory assessment process, we asked 

whether a poorly written document negatively influences the 

review of other documents from the same applicant. Almost a 

third (27%) of participants agreed that poor document quality 

Figure 3. Does poor document quality impede 
your ability to provide regulatory assessment?

Figure 4. How often do you encounter issues related 
to document quality during the review process?

100%

80%

60%

40%

20%

0%
Yes No Neutral/no opinion

Responses: 23

Figure 5. What percentage of applications do you 
reject/send back to the applicant with questions due 
to poor document quality?

50%

40%

30%

20%

10%

0%

Responses: 19

<10% 10%-25% 26%-50% >50%

Figure 6. For applications that are ultimately  
approved, a poorly written document delays the  
approval process.

60%

50%

40%

30%

20%

10%

0%
Strongly 

agree
Agree Neither agree 

nor disagree
Disagree

Responses: 22

Strongly
disagree

60%

50%

40%

30%

20%

10%

0%
Never Rarely Sometimes Often

Responses: 23

Always



148    AMWA Journal / V36 N4 / 2021 / amwa.org        

could negatively influence their review of the applicant’s other 

documents. It should be noted that we did not define what this 

means in practice, eg, whether the reviewer would be likely 

to review the applicant’s other documents in more detail or 

whether this approach would carry over to documents in later 

submissions. The same percentage (27%) disagreed with the 

question, and 45% neither agreed nor disagreed. This indicates 

that, in some cases, poor document quality can even influence 

the assessor’s review of the applicant’s other documents.

 The survey included questions around whether the regu-

latory agencies collect data themselves on document quality. 

Three participants (13%) confirmed that their agency collects 

such data, 35% responded that these data are not collected, 

and 53% did not know. When asked what the agency does with 

the data, one participant stated the data are reviewed, but 

the majority skipped the question. Most participants (90%) 

responded that their agency does not keep a record of appli-

cants that regularly submit poorly written documents.

QUALITY ISSUES OBSERVED BY THE 
REGULATORS
Having established that document quality has a significant 

effect on the regulatory assessment process, it was important 

to understand which kinds of document quality issues are 

observed by the regulators. For the questions designed to  

identify these quality issues, participants were provided  

with the following response options (Figure 7).

 When asked to identify all quality issues encountered 

(Figure 8), those most frequently reported by the regulatory 

reviewers were excessive length/repetition/verbosity, closely 

followed by lack of clarity. This will not surprise most medical 

writers, who expend great effort working with teams to  

produce documents that are clear and concise with well- 

organized messages. However, these results do demonstrate that 

the effort invested in these aspects is warranted and necessary 

to meet the needs of the regulatory assessors. Of note, issues 

such as data errors, incomplete content, broken links, and poor 

tables/graphs were ranked relatively low in this question, which 

suggests many applicants have implemented processes to catch 

these avoidable issues prior to document submission.

 In addition to the range of quality issues typically observed, 

we asked the regulatory reviewers to identify the one docu-

ment quality issue they encountered most frequently (Figure 9). 

Excessive length/repetition/verbosity was ranked top here, too, 

closely followed by poor explanation of rationale. Once again, 

avoidable issues (data errors, incomplete content, poor tables/

graphs, poor language) were ranked low or not at all.

Poor organization

Poor language usage

Lack of clarity

Poorly designed/presented tables and graphs

Data errors (eg, inconsistencies, transcription errors)

Incomplete content

Poor explanation of rationale

Excessive length, unnecessary repetition, verbose

Incorrect format/nonadherence to guidance

Broken/incorrect or insufficient crosslinks

Other

None

Figure 7. Examples of quality issues used in survey 
questions.

Excessive length, repetition,  
verbose

Lack of clarity

Poor explanation of rationale

Nonadherence to guidance

Poor organization

Poor language usage

Broken/incorrect crosslinks

Incomplete content

Data errors

Poorly designed tables /graphs

None of the above

Other

20%0% 40% 60% 80%

Responses: 22

Figure 8. Which of the following issues related to document 
quality do you typically encounter? Check all that apply.

Figure 9. Which one of these issues related to document 
quality do you encounter most frequently?

Excessive length, repetition,  
verbose

Lack of clarity

Poor explanation of rationale

Nonadherence to guidance

Poor organization

Poor language usage

Broken/incorrect crosslinks

Incomplete content

Data errors

Poorly designed tables /graphs

None of the above

Other

10%0% 20% 30% 40%

Responses: 22



      AMWA Journal / V36 N4 / 2021 / amwa.org    149

 Understanding the range and frequency of quality issues 

will help the medical writing profession and the industry to 

improve processes that support document quality and to 

target training and skills development for authoring teams. 

It is also important to understand whether specific quality 

issues have a greater effect on the assessor’s review and appli-

cation approval, regardless of how frequently they occur. Poor 

explanation of rationale caused the greatest negative effect on 

review or caused the most irritation to the regulatory reviewer, 

with excessive length ranked second (Figure 10). When asked 

to identify the one issue that has the greatest negative effect 

on application approval, the regulatory reviewers also ranked 

poor explanation of rationale at the top (Figure 11), followed by 

incomplete content. Poor explanation of rationale, therefore, 

is not only one of the most frequently observed quality issues, 

but also caused the most irritation to reviewers or negatively 

affected their review and has the greatest negative effect on 

approval. Clear strategic presentation of rationale supported 

by data should be a top area of focus for the teams responsible 

for documents submitted to regulatory agencies.

 It is also interesting that, although incomplete content is 

not among the most frequent quality issues, the responses sug-

gest it has a large negative effect on application approval when 

it does occur. It is therefore important for applicants to have 

rigorous processes to validate documents for completeness 

before submission. In converse, excessive length was ranked 

as the most frequent and was among the top document quality 

issues that cause irritation or have a negative effect on regula-

tory review, yet it is not among the top issues that negatively 

affect application approval.

REGULATORS’ PERCEPTION OF MEDICAL 
WRITING
Beyond their view of the documents themselves, we wanted to 

understand what the regulatory reviewers thought of medical 

writers, their role, and their effect on the documents sent to the 

regulators for review.

 Of those who responded, 67% were familiar with the con-

tribution of medical writers to the documents they review. 

Importantly, 70% either agreed or strongly agreed that medi-

cal writers improve the quality of these documents, and a clear 

majority (87%) agreed or strongly agreed that sponsor com-

panies with established medical writing functions and rigor-

ous document development processes and standards produce 

higher quality submissions. Although this last question was 

asked before we had given examples of quality (and so the reg-

ulatory reviewers have used their own idea of a high-quality 

document), the responses strongly indicate that medical writ-

ers improve quality and established medical writing functions 

and processes produce higher quality documents.

 We asked the regulators to indicate any areas where they 

believed that medical writers add value to regulatory docu-

ments. Over 78% identified “adherence to standards,” and 71% 

identified “accuracy.” This was closely followed by 64% for each 

of the following:

• Clarity

• Completeness

• Explanation of rationale

• Formatting

It is particularly reassuring that the regulatory reviewers 

believe that medical writers add value in the areas of accu-

racy, adherence to standards, and also explanation of rationale, 

which the previous questions had clearly identified as a key 

area of concern for them. However, it should be noted that this 

Figure 10. Which one of these issues related to document 
quality most negatively affects your review/causes the 
most irritation?

Excessive length, repetition,  
verbose

Lack of clarity

Poor explanation of rationale

Nonadherence to guidance

Poor organization

Poor language usage

Broken/incorrect crosslinks

Incomplete content

Data errors

Poorly designed tables /graphs

None of the above

Other

10%0% 20% 30%

Responses: 22

Figure 11. Which one of these issues related to document  
quality has the greatest negative effect on application approval?

Excessive length, repetition,  
verbose

Lack of clarity

Poor explanation of rationale

Nonadherence to guidance

Poor organization

Poor language usage

Broken/incorrect crosslinks

Incomplete content

Data errors

Poorly designed tables /graphs

None of the above

Other

10%0% 20% 30%

Responses: 22



150    AMWA Journal / V36 N4 / 2021 / amwa.org        

question was only answered by 14 respondents, and so the 

results should be interpreted with caution.

FOLLOW-UP INTERVIEWS
Some of the participants indicated that they would be happy 

to give more detail about their survey answers. We arranged 

individual interviews to gather this information, which was 

anonymized and amalgamated and is presented below.

Quality Issues and Document Type
Because the survey had identified quality issues in some of 

the documents that the regulatory reviewers receive, it was 

important to understand if these were most prevalent in 

one document type (suggesting an issue with the template 

or understanding of the requirements) or were seen in all 

of the document types received. The regulatory reviewers 

confirmed that quality issues were seen generally across all 

document types. They explained that templates or guidance 

cannot address all the nuances of writing these documents 

and so experienced writers are needed.

“Explanation of Rationale” as the Key Quality 
Issue
Explanation of rationale was identified as a key area of impor-

tance for the regulatory reviewers, and they explained that 

this was because it can take them a lot of time to interpret 

what the author intended to communicate. The review-

ers often go back to the sponsor for clarification, but this 

depends on several factors:

• The type of document being reviewed (eg, lack of clarity 

or other issues affecting safety are usually much more 

concerning than issues of lesser consequence)

• Timeline (eg, whether the reviewer has the time to work 

through the misunderstanding/quality issue them-

selves)

• Complexity (eg, whether the reviewer is able to work 

through the quality issue in the document compared 

with sending it back to the sponsor)

• Resources (eg, whether a specialist is available on the 

regulatory agency side to review the document to help 

with the quality issue)

The impact of a document with a poorly written rationale 

can be significant. Some regulatory agencies could inter-

pret a poorly written rationale as lack of transparency, which 

could then call the entire application into question (a “domino 

effect”), and documents with poor rationales would likely be 

flagged at each review step for extra investigation, which would 

affect the whole application. It was widely accepted that a 

poorly written rationale makes the entire review process more 

difficult and would have a negative effect on approval.

Other Document Quality Issues
Although we asked about the most common issues negatively 

affecting document quality, we wanted to know if the  

regulatory reviewers encountered other issues that we had  

not specified.

 Lack of transparency was identified as a key issue, par-

ticularly if the regulatory agency had experienced challenges 

with the sponsor or their applications previously. A lack of 

transparency and lack of clarity around the sponsor’s objec-

tives can raise regulatory reviewers’ suspicions and give 

the impression that the sponsor is trying to overwhelm the 

reviewer with a mountain of data.

 Transparency in terms of minutes from meetings with 

other regulatory agencies was also required, and a reluctance 

to provide these documents delays approval because it takes 

extra time to request them. The reviewers explained that it is 

important for them to see the concerns and requirements in 

other regions.

Medical Writers’ Influence on Document Quality 
and Their Role
We asked what influence the regulatory reviewers felt that 

medical writers had on document quality and the medical 

writer’s role. The responses were extremely heartening and 

reflected the aims of the medical writing profession.

 The regulatory reviewers felt that medical writers have 

a “great and positive influence on document quality; they 

help keep documents clear, as brief as they can be, and con-

sistent.” They felt that there is “definitely a difference when 

medical writers have been involved” in document produc-

tion and that they can tell if inexperienced writers have been 

used, as they see a lack of attention to detail and adherence  

to standards.

 The regulatory reviewers felt that “a professional medical 

writer is always welcome and is always needed” and believe 

that the importance and value of medical writers “continues 

to grow,” to the extent that some regulatory agencies have 

established their own medical writing teams.

The regulatory reviewers felt 

that medical writers have a 

“great and positive influence 

on document quality; they help 

keep documents clear, as brief as 

they can be, and consistent.”



AMWA Journal / V36 N4 / 2021 / amwa.org    151

 One of the reviewers summed up the situation beautifully: 

“I know that it is a very specific profession needing training. 

[Sometimes] we cannot tell who has written what in the appli-

cations or how much medical writers have been involved—it 

is invisible from the regulatory agency point of view. We don’t 

need to know, we just want something of good quality!”

Anything Else?
Finally, we asked a very open question—were there any other 

comments that the regulatory reviewers would like to make 

concerning document quality or the role of professional medi-

cal writers?

 They explained that, beyond scientific expertise, medical 

writers should be involved in document production to make 

the information understandable and usable for the reviewer. 

They emphasized that they cannot “transform a bad docu-

ment”—if the information they are given is not understand-

able, they cannot reply to it, which they found very frustrating 

because their role is to encourage and facilitate drug develop-

ment. Often, regulatory reviewers can see that there is excel-

lent science and work behind the document, but because it has 

been written badly, they are forced to guess what the messages 

are. They believed that although the role and work of medi-

cal writers may not be immediately visible to them, it was a 

“major” contribution.

 Their final comment was that there was “no negative in 

having medical writers involved in document development—

their influence and contributions are always positive.”

LOOKING FORWARD
The objectives of the survey were to gain an understanding of 

how regulatory agencies perceive the value of medical writing 

and to learn where to focus the training and development of 

medical writers to maximize the value in, and skill set for, the 

preparation of regulatory documents.

 The survey responses showed that many regulatory review-

ers understand the role of medical writers, believe that they 

increase the quality of the documents sent to the agencies for 

review, and make the job of the regulatory reviewer easier. It is 

unsurprising that document quality is extremely important for 

regulatory reviewers. Participants reiterated that poor docu-

ment quality can not only hamper the ability of the reviewer to 

provide an assessment (delaying the drug approval process), 

but also has the potential to bias reviewers against subse-

quent submission documents from the same sponsor. There is 

a clear opportunity for medical writers to improve document 

quality, and the survey responses can also be used to inform 

how medical writers present themselves within their organiza-

tions—quality is clearly top of the regulatory reviewers’ list of 

priorities and has been recognized by them as an area where 

medical writers add value.

 Most satisfyingly, regulatory reviewers appreciated and 

recognized the work and importance of trained medical writ-

ers; thus, addressing regulatory reviewers’ needs should con-

tinue to be a priority for the profession. Training must equip 

medical writers to lead teams that create documents that are 

concise and clearly present the message supported by the data. 

Perhaps even more focus should be given to team manage-

ment and soft skills to allow medical writers to lead and guide 

these teams so that the documents supporting submissions are 

as concise and strategic as possible to streamline and increase 

efficiency of the whole clinical development process.

 The fact that the regulator reviewers, who are often time-

poor, chose to take the time to help us to understand the role 

and value of medical writers is a testament to the importance 

of our profession and the expertise that trained medical writers 

bring to the development of regulatory documents and their 

associated teams.

Acknowledgment

Thanks to Susan Krug, AMWA Executive Director, who pro-

vided significant support setting up the survey and with com-

munication to survey participants.

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: julia.cooper@parexel.com

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

writing support. Curr Med Res Opin. 2014;30(10):2103-2108.

2. Woolley KL, Lew RA, Stretton S, et al. Lack of involvement of medical 

writers and the pharmaceutical industry in publications retracted for 

misconduct: a systematic, controlled, retrospective study. Curr Med Res 

Opin. 2011;27(6):1175-1182.

mailto:julia.cooper@parexel.com



