





































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

ABSTRACT
The American Medical Writers Association formed a working 

group in 2020 focused on understanding and communicating 

the value that regulatory medical writers contribute to proj-

ect teams, companies, and the wider research community. The 

working group developed a survey designed to gather infor-

mation about the value that regulatory writers represent. The 

survey was targeted to regulatory medical writers, included 25 

questions, and was administered by using SurveyMonkey. A 

total of 548 responses were received, and 522 of the respondents 

were active regulatory medical writers. The survey revealed that 

writers felt most valued when they were consulted or had their 

opinion sought (n = 154, 30.8%), contributed to patients and 

the community (n = 89, 17.8%), and were well compensated 

(n = 80, 16.0%). Writers felt that their most valuable contribu-

tions to document preparation were clarity (n = 196, 44.1%) and 

organization (n = 80, 18%). Although most writers indicated 

that their employers provided sufficient opportunities for train-

ing and advancement (strongly agree, n = 131, 29%; agree, n 

= 197, 44.1%), writers also indicated they would benefit from 

additional training in leadership skills, project management, 

and collaborative skills/diplomacy. This insight is invaluable for 

shaping the future of the regulatory writing profession.

 

INTRODUCTION
At its core, medical writing involves gathering, organizing, 

interpreting, and presenting complex information in a clear, 

concise, and coherent manner to a variety of audiences. 

Specific responsibilities can vary greatly across the industry, 

with roles and opportunities for medical writers constantly 

evolving. In this ever-changing environment, the role of regu-

latory medical writers is not always clear, and there is evidence 

to suggest that medical writers’ contributions are not always 

fully understood or recognized.1 To better appreciate the con-

crete value regulatory medical writers contribute to projects, 

teams, companies, and the wider biopharmaceutical industry, 

the American Medical Writers Association (AMWA) Executives 

Forum established a taskforce to define and quantify the value 

of medical writing. The 3 focus areas of the taskforce include 

writers’ perceptions of their own value, regulatory agency per-

ceptions of a writer’s value, and other key topics related to 

the value of medical writers. This article describes the work of 

the subgroup tasked with determination of regulatory medi-

cal writers’ perceptions of their own value. The main goals of 

this subgroup were to discover the views of regulatory medical 

writers regarding the nature of the value they contribute, iden-

tify aspects of the role that make writers feel most valued, and 

inquire about team feedback and dynamics. We also sought to 

identify additional skills, training, and opportunities for devel-

opment that would benefit writers while also increasing the 

satisfaction of their teams.

METHODS
A 25-question survey was designed to evaluate multiple 

domains regarding the perceived value and contributions 

of regulatory medical writers. The intended time taken for 

respondents to complete the survey was 10 minutes, and the 

average duration of participation was determined to be less 

than 10 minutes. Many of the survey questions were multi-

ple-choice questions, with some requesting a single answer 

and others allowing multiple answers (check all that apply). 

Additional questions allowed participants to rank their prefer-

ences. Other questions were presented in a 5-point Likert-scale 

format. One question was an open field that allowed partici-

pants to provide general comments on the topic at hand.

Dylan Harris,1 Cathy Tyrrell,2 Amy Myers,3 Cynthia Carr,4 and Karen L. Fink,5 on behalf of the AMWA 
Value of Medical Writing Working Group / 1Takeda Pharmaceutical Company Limited, Lexington, MA, 
USA; 2Seqirus, a CSL Limited Company, Summit, NJ, USA; 3Jazz Pharmaceuticals PLC, Dublin, Ireland; 
4Roche Tissue Diagnostics, Tucson, AZ, USA; 5Harpoon Therapeutics, South San Francisco, CA, USA

Value of Medical Writing: The Regulatory  
Writer’s Perspective

F
E

A
T

U
R

E



      AMWA Journal / V36 N4 / 2021 / amwa.org    153

 The survey was targeted to regulatory medical writers; 

the first question in the survey was binary (yes/no) and con-

firmed this status. The survey was administered by using 

SurveyMonkey to members of the AMWA medical writing com-

munity, the European Medical Writers Association (EMWA) 

medical writing community, and the DIA Medical Writing 

Community. Working group members also distributed the 

survey to colleagues who were known to be regulatory medical 

writers and to partner companies who had regulatory medical 

writing groups who agreed to participate.

 The survey was completely anonymous. However, some 

analyses utilized the anonymized participant number to track 

responses to different questions from the same participants in 

attempting to identify trends in the data.

PARTICIPANT PROFILE
To better understand the characteristics of survey participants, 

several survey questions focused on demographics and work 

history. In response to the question, “Are you currently work-

ing (or have you worked within the past 5 years) as a regula-

tory medical writer?” we received a total of 548 responses, and 

522 respondents (95.3%) confirmed current employment as 

regulatory medical writers. The second question in the survey 

inquired about work status. A total of 548 responses were also 

received for this question, and 488 (89.1%) were “employed,” 

whereas 53 (9.7%) were “freelance or self-employed,” 4 (0.7%) 

were “retired or unemployed,” and 3 (0.5%) chose “other” 

as a category of employment. When asked about the type of 

company the respondents were employed by, a total of 518 

responses were received, and the top 3 responses were (1) 

pharmaceutical company, (2) clinical or contract research 

organization, and (3) biotechnology company (Table 1).

 When writers were asked about the larger group in which 

the regulatory writing group resided, the top response indi-

cated that medical writing stood alone as a group (Table 2). 

However, as this is contrary to the experience of the members 

of the AMWA working group, it may be suggestive of some 

ambiguity inherent in the question, although it may be a pre-

dictable response in smaller companies or in clinical research 

organizations (Table 1; 22.8% of respondents). Some of the 

responses in the “other” category included “Clinical Affairs,” 

“Data Science and Safety Reporting,” “Document Solutions 

Group,” and “Regulatory Documentation and Submissions.”

 The tenure of the regulatory writers who responded to 

the survey reflected long-term experience and the longev-

ity of their dedication to the profession. A total of 444 writers 

responded to our question about years of writing experi-

ence, 242 (54.5%) of whom had more than 10 years of experi-

ence in the regulatory writing profession. A total of 84 (18.9%) 

respondents had between 6 and 10 years of writing experience, 

whereas 91 (20.5%) had between 2 and 5 years of experience 

and 27 (6.1%) had less than 2 years of experience. More than 

half of respondents had either a PhD degree (n = 206, 46.4%) or 

another advanced degree (n = 27, 6.1%); 147 (33.1%) respon-

dents had a master’s degree, 56 (12.5%) had a bachelor’s degree 

and 8 (1.8%) respondents specified a degree of “other.” A total 

of 440 writers responded to a query regarding gender, with 330 

(75%) writers identifying as women, 83 (18.9%) identifying as 

men, and 27 (6.1%) choosing “prefer not to say.” Overall, pro-

fessionals responding to this survey were highly educated, a 

high proportion were women, and most had long-term expe-

rience as regulatory writers. This is indicative of a profession 

that generally requires a high level of education and offers 

Table 2. Organizational Structure Housing Regulatory Writing Group

Parent Group/Organization
Responses  

(n)
Responses  

(%)

Medical Writing Stand-Alone 
Group/Function

198 38.2

Regulatory Affairs 115 22.2

Clinical Development 68 13.1 

Clinical Operations 52 10.0

Other (Please Specify) 32 6.2

Biostatistics or Biometrics 18 3.5

Not Applicable 16 3.1 

Medical Affairs 11 2.1 

Strategic Operations 4 0.8 

Pharmacovigilance 2 0.4 

Quality 2 0.4

Table 1. Analysis of Employment for Regulatory Medical Writers

Type of Employer
Responses  

(n)
Responses  

(%)

Pharmaceutical Company 261 50.4

Clinical or Contract Research  
Organization

118 22.8

Biotechnology Company 56 10.8

Medical Device Company 29 5.6

Medical Communication Company 23 4.4

Full Service Provider/Staffing Company 15 2.9

Other (Please Specify) 13 2.5

Medical School or University 2 0.4

Medical Marketing, Advertising, or  
Public Relations Agency

1 0.2



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

long-term employment and development. The paucity of 

respondents with less than 2 years of experience (6.1%) may 

reflect slow recruitment of writers or a slow growth rate for 

the pool of regulatory writing professionals. Alternatively, it 

could represent our inability to reach more junior medical 

writers. However, if this rate is representative of the industry 

at large, it is concerning, given the high growth rate for medi-

cal writing needs in the biopharmaceutical industry.

ROLES AND CAREER PROGRESSION
We inquired about specific roles of medical writers to better 

understand how they are contributing, to learn what employ-

ers expect from medical writers, and to explore the relation-

ship between required level of skill and the various roles of 

the writer. These survey questions categorized medical writ-

ing roles to reflect increasing levels of both technical skill 

and responsibility in order to understand the distribution of 

skills within the respondent pool (Table 3). The majority of 

respondents report involvement in activities beyond basic 

document preparation following a template. Most provide 

strategic guidance to teams and participate in some form of 

project management activity. Consistent with the long dura-

tion of tenure in the respondent pool, a relatively large pro-

portion of respondents identified themselves with role C, 

representing a very high level of technical skill, knowledge, 

and responsibility.

 To better illustrate the relationship between experience 

and role, we analyzed the responses for each role by years of 

experience (Figure 1). Although there was not an exact linear 

correspondence in the relationship between increasing years 

of experience and increasingly challenging roles, there was 

certainly a trend for professionals with longer tenure to fill the 

more challenging roles. Most individuals in the management/

project management category had at least 10 years of experi-

ence in regulatory writing. These data indicate that regulatory 

writing is a highly technical discipline, and development of the 

necessary expertise to assume more strategic and management 

responsibilities appears to require several years to develop. 

This also suggests that regulatory writing is a career that offers 

long-term progression and development.

VALUE ASSESSED BY WRITERS AND TEAMS
Understanding and harnessing the skill set of experienced 

regulatory writers can keep writers engaged and make them 

feel satisfied and fulfilled. When writers were asked what made 

them feel most valued as a medical writer (and were forced 

to choose one answer), there was a clear leader among the 

options provided (Table 4). Medical writers felt most valued 

when their opinions were sought and when they were included 

in decision-making. This aspect of feeling valued was chosen 

by more respondents than any other aspect, including com-

pensation and other forms of recognition. Some responses 

in the “other” category were (1) “medical writers have unique 

skills that fill a need, unmet by any other discipline involved in 

healthcare”; (2) “coaching and training of new or junior writ-

ers”; and (3) “authorship and being consulted; having my ideas 

taken seriously and acted upon.”

 The same question was posed with a requirement to rank 

these items and there was an identical response pattern, 

except that “autonomy/flexibility” and “recognition” switched 

Table 3. Analysis of Roles Among Regulatory Writers

Role
Responses  

(n)
Responses  

(%)

A.   I Provide Medical Writing 
Support/Service to Teams That 
Is Mainly Focused on Document 
Preparation, Using Knowledge 
of Templates, and ICH and Other 
Guidance(s).

138 27.6

B.   I Provide Support Described 
in Item A, but Also Provide 
Strategic Guidance to the Teams.

126 25.2

C.   I Provide Support In Items A 
and B and Manage Submissions 
Documents and Lead Teams 
Through CTD Preparation 
Routinely.

171 34.2

D.  Management and/or Project 
Management.

43 8.6

Other (Please Specify). 22 4.4

CTD, Common Technical Document; ICH, International Council for  
Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

Figure 1. Relationship between experience and roles. CTD, Common 
Technical Document.

100%

80%

60%

40%

20%

0%
A

Management
Project

Management

Submission/CTD 
Preparation/
Management 

plus B (C)

Strategic
Guidance
plus A (B)

Document 
Preparation

(A) ➔ ➔ ➔

B C D
< 2 years 2 to 5 years 6 to 10 years > 10 years

(n=138) (n=126) (n=171) (n=43)



      AMWA Journal / V36 N4 / 2021 / amwa.org    155

positions in the rate of response/rank. Interestingly, “career 

progression/job title/opportunity for movement” remained at 

the bottom of the list, with only 4.7% of respondents choosing 

this as their top ranked item.

 Many writers felt that their tactical and technical skills 

were fully utilized, as well as their scientific and strategic skills 

(Figure 2; n = 495).

 Additionally, most writers felt that the teams they sup-

ported fully recognized their value and skills. A total of 265 

(53.5%) respondents agreed with this statement, whereas 107 

(21.6%) strongly agreed. Interestingly, only 48 (9.7%) respon-

dents disagreed, and 6 (1.2%) strongly disagreed. Consistent 

with these positive responses, most writers also felt that they 

were empowered by management to provide clear guidance 

to their team regarding the document development processes 

and felt they were included in most necessary meetings that 

enabled them to remain aware of strategic decisions that could 

impact document development (Figure 3; n = 495).

Table 4. What Makes Regulatory Writers Feel Valued

What Makes Me Feel Valued?
Responses 

(n)
Responses 

(%)

Consulted/Opinion Sought/
Decision-Making

154 30.8

Making a Contribution to 
Patients/Community

89 17.8

Compensation 80 16.0

Involvement in Scientific 
Research/Developing Your Own 
Scientific Knowledge

77 15.4

Autonomy/Flexibility 32 6.4

Recognition 31 6.2

Career Progression/Job Title/
Opportunity for Movement

28 5.6

Other (Please Specify) 9 1.8

Figure 2. Utilization of skill sets.

0% 20% 60%40%

Strongly Agree

Agree

Strongly 
Disagree

Disagree

Neither Agree 
or Disagree

Technical and Tactical Skills

0% 20% 60%40%

Strongly Agree

Agree

Strongly 
Disagree

Disagree

Neither Agree 
or Disagree

Scientific and Strategic Skills

Figure 3. Key determinants of success.

0% 20% 60%40%

Strongly Agree

Agree

Strongly 
Disagree

Disagree

Neither Agree 
or Disagree

Empowered by Management

0% 20% 60%40%

Strongly Agree

Agree

Strongly 
Disagree

Disagree

Neither Agree 
or Disagree

Included in Key Meetings



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

 Although regulatory writers provide value to teams in many 

ways, we sought to understand the perception of writers  

themselves in terms of the value they contribute. When writers 

were asked to select one area in which they provide the most 

value in document preparation, there was a clear top choice 

(Table 5). Writers indicated that they contributed the most 

value by providing clarity in documents (44.1%), followed by 

“organization” (18.0%), “completeness” (10.1%), “accuracy” 

(9.9%), and “adherence to standards” (9.9%).

 When writers were asked this same question but allowed 

to check all areas in which they contributed value, clarity was 

still at the top of the list (95.3% of writers included this in their 

selections), and organization was still in second place (90.8% 

of writers included this in their selections).

 A general comment regarding the value of medical writ-

ers was provided by 102 (18.6%) writers. Key themes in the 

responses were the value provided to teams to ensure that the 

documents will lead to a successful submission. An example is 

this response: “The quality and delivery time of regulatory doc-

uments improved dramatically when my employer established 

a medical writing department within Clinical Operations.” The 

responses indicate that clear, well-written, and accurate mes-

sages are an important part of the medical writer’s role and 

that this is best achieved by integration into project teams. A 

response that expressed this was, “Clinical–regulatory writ-

ers are critical members of the team who guide development 

of documents with an overall perspective for program strategy 

and a document that is complete, accurate, and well-written.” 

The responses indicate that this enables the medical writer to 

lead team collaboration, ensure that documents support proj-

ect goals, and drive the process to speed delivery and ensure 

high quality/regulatory compliance. A representative response 

was, “We take ownership and drive/lead the document through 

the process, and only by guiding the team do we get through 

it.” Several writers stated that the role of the medical writer is 

underappreciated. Insight is provided by this response: “Much 

of the value can go unnoticed by management as it is difficult 

to measure what good clinical–regulatory writers provide to 

documents and the document completion process.”

 Pivoting to inquiry regarding the value that teams perceive 

as writers’ greatest contributions, the skills that writers felt they 

were most frequently recognized for were leadership and col-

laboration skills (Table 6), both considered to be behavioral 

skills or “soft skills” rather than technical skills directly related 

to writing.2

 When asked to rank the frequency of recognition of skills, 

the 3 top responses remained consistent, with all the other 

skills/behaviors ranking at least 5% beneath the third most 

highly ranked skill (Table 6; 17.5%, providing strategic guid-

ance on document development and/or submissions). 

Interestingly, when this line of inquiry was reversed and we 

asked writers to provide information about constructive feed-

back they received from teams about areas for improvement, 

responses in the “other” category represented the highest pro-

portion of responses (Table 7; n = 110, 24.4%). However, the 

most common entries in the “other” category open field were 

“none” and “not applicable,” and there was no consistent 

trend, suggesting that inclusion of that option/field may have 

detracted from the precision of the data. The next 2 most  

Table 5. Areas in Which Writers Provide Value in Document Preparation

Area of Document Preparation
Responses 

(n)
Responses  

(%)

Clarity 196 44.1

Organization 80 18.0

Completeness 45 10.1

Accuracy 44 9.9

Adherence to Standards 44 9.9

Explanation of Rationale 22 5.0

Brevity 9 2.0

Formatting 4 0.9

Linking 0 0.0

Table 6. Skills and Contributions Recognized Most Frequently by Teams

Skill Recognized by Teama
Responses 

(n)
Responses  

(%)

Leadership, Including 
Management of the Process and 
Maintenance of Timelines

148 32.8

Collaboration and Flexibility 116 25.7

Providing Strategic Guidance on 
Document Development and/or 
Submissions

79 17.5

Writing Skills With Respect to  
Vocabulary and Sentence 
Structure, Grammar, Improved 
Readability, etc.

34 7.5

Comment Resolution and 
Achievement of Consensus

26 5.8

Problem-Solving 19 4.2

Quality Control and Accuracy 19 4.2

Compliance 5 1.1

Input to Study Design and Project 
Decisions

5 1.1

aSurvey respondents had to choose only one skill.



      AMWA Journal / V36 N4 / 2021 / amwa.org    157

frequent responses were (1) leadership, including management 

of the process and maintenance of timelines, and (2) improve 

flexibility. Therefore, the 2 items writers felt they were most fre-

quently recognized for doing well were also the 2 specific items 

for which they felt that teams requested improvement or better 

support. These data suggest that leadership and collaboration 

should be key areas of focus for writer development.

 When writers were asked to rank (from 1 to 7) the 7 skills 

for which teams had requested better support (“other” was not 

included), leadership and lack of flexibility were still cited as 

the top areas for improvement (Table 7).

TRAINING OPPORTUNITIES AND NEEDS
One of the main reasons for conducting this research was to 

identify potential gaps between medical writer skills and team 

and/or employer expectations. Although this investigation 

relies on information gathered from regulatory writers and not 

teams or employers, we can compare our results with research 

conducted by another group2 as it relates to the pharmaceutical 

medical writing competency model.3 According to information 

Heisel-Stoehr and Schindler obtained from 73 job advertise-

ments for regulatory medical writers, “science” and the “com-

prehension of scientific concepts” were important technical 

skills cited in 78% and 92% of those job advertisements, respec-

tively.2 Our survey suggests that writers are not primarily recog-

nized for such contributions during document development. 

Additionally, writers themselves felt that their most important 

contributions to document development were clarity and orga-

nization, technical writing skills that may or may not require a 

deep scientific understanding. On the other hand, the 73 job 

advertisements described by Heisel-Stoehr and Schindler cited 

“leadership and team working skills” as the most frequently 

(62%) mentioned behavioral skill/skills for regulatory writ-

ers.2 In fact, our survey results find that these are the 2 areas 

for which writers are most frequently recognized by teams for 

commendable performance (Table 6).

 Although most writers in our survey felt that their employ-

ers provided them with sufficient opportunities for training and 

development to enable success and advancement (agree,  

n = 197, 44.1%; strongly agree, n = 131, 29.3%), there were 

others in the survey who felt neutral (neither agree or dis-

agree, n = 78, 17.4%) and some who disagreed (n = 30, 6.7%) or 

strongly disagreed (n = 11, 2.5%). These results speak well of 

management efforts to keep writers engaged and developing. 

When writers were asked to identify areas in which they needed 

more opportunities to learn, there was a significant focus on (1) 

leadership skills, (2) project management, and (3) collaborative 

skills/diplomacy (Figure 4). Once again, the notion that behav-

ioral skills or “soft skills” play a prominent and crucial role in 

the successful execution of the duties of the regulatory writer is 

reinforced throughout the results of our survey.

SUMMARY
Results from the survey encompassing 548 respondents with 

regulatory medical writing experience revealed key information 

that is useful for understanding the value that medical writ-

ers bring to an organization and useful for further defining job 

responsibilities and skills needed for regulatory medical writ-

ers. Regulatory medical writers are highly educated profession-

als whose development to attain the skills necessary for leading 

regulatory submission preparation and managing projects and 

teams requires several years. The role requires both techni-

cal/tactical skills and scientific/strategic skills. Most regulatory 

medical writers report that their duties extend beyond basic 

Table 7. Constructive Feedback From Teams

Skill That Needs Improvement
Responses 

(n)
Responses  

(%)

Other (Please Specify) 110 24.4

Leadership, Including 
Management of the Process and 
Maintenance of Timelines

79 17.5

Lack of Flexibility 62 13.7

Compliance With Procedures 61 13.5

Comment Resolution and 
Achievement of Consensus

45 10.0

Writing Skills With Respect to  
Vocabulary and Sentence 
Structure, Grammar, Improved 
Readability, etc.

36 8.0

Quality Control, Too Many Errors 36 8.0

Collaboration 22 4.9

Figure 4. Areas desired for more training/learning.

0% 20% 60%40%

Project 
Management

80%

Leadership
Skills

Collaboration
Skills/Diplomacy

Effective
Communication

Technical / 
Writing Skills

Quality Control

Other  
(please specify)



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

document preparation following a template to include provid-

ing strategic guidance to teams and participating in some form 

of project management activity. Project teams rely on medical 

writers for leadership and collaborative skills. Medical writers 

recognize these soft skills as both their key contributions and 

their key training needs. Data suggest that regulatory medical 

writers feel most valued when their opinions are sought and 

when they are included in decision-making.

 

Acknowledgement

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

vided significant support setting up the survey and with com-

munication to survey participants. We also wish to thank the 

membership of AMWA, EMWA, and the DIA medical writing 

communities for their participation in the survey. 

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 not neces-
sarily shared by their employers or AMWA.

Author contact: dylan.harris@takeda.com

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

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

2. Heisel-Stoehr S, Schindler TM. Pharmaceutical medical writing 

competencies: comparing self-perception with employers’ expectations. 

Med Writing. 2012;21(3):225-231.

3. Clemow D; DIA Medical Writing Special Interest Area Community 

Competency Model Working Group. Pharmaceutical medical writing 

competency model. AMWA J. 2011;26(2):62-70.

Get FIT
with AMWA
 F  AST
 I  NTERACTIVE
 T RAINING

AMWA’s FIT Series helps medical 
communicators stay healthy. In only 15 
minutes—jog your memory, tone your 
writing muscles, build your core skills, 
and stretch your knowledge.

www.amwa.org/fit

Only $15 each   /  Approved for .5 CE

Topics in the series include:
}  Misplaced Modifiers }  Mean, Median, and Mode
}  Dangling Participles }  Measures of Variability 




