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

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ABSTRACT
The American Medical Writers Association (AMWA) Third 

Annual Medical Writing Executives Forum brought together 

executives of medical writing departments at some of the 

world’s top biopharmaceutical companies to discuss topics 

of urgent relevance to the companies that employ regula-

tory medical writers, those who manage regulatory medical 

writing teams, and regulatory medical writers themselves. 

Participants identified and discussed many of the chal-

lenges and opportunities facing the industry today.

In 2018, the American Medical Writers Association (AMWA) 

launched the AMWA Medical Writing Executives Advisory 

Council for the purpose of maintaining a connection 

between pharmaceutical and biotechnology department 

heads and the AMWA Board of Directors. The council com-

prises senior-level professionals whose responsibility it 

is to recruit, train, and manage medical communicators. 

Members of the council represent some of the world’s top 

health-science, pharmaceutical, and biotechnology com-

panies as well as several companies that provide regulatory 

medical writing and consulting services. The council acts 

as a sounding board on issues such as workforce trends, 

training programs, and technologies that have an impact 

on the medical writing field. Council members also provide 

guidance on and participate in the annual AMWA Medical 

Writing Executives Forum.

 The third annual invitational Medical Writing Executives 

Forum was held virtually on October 25, 2021. Joan Affleck, 

MBA, ELS, Associate Vice President and Head of Medical 

Writing at Merck & Co., chaired the forum. A list of forum 

attendee companies is provided in the table. The theme of the 

forum was Igniting Leadership, Innovation, and Resilience in 

Medical Writing. Participants divided into 5 breakout groups, 

each addressing a specific topic pertaining to the value of 

medical writing, next-generation leadership, the changing 

medical writing environment, recruiting and retaining  

medical writers, or leading in times of change. This article 

reports the key opportunities, challenges, insights, observa-

tions, and recommendations of the forum participants.

Brian Bass, MWC / Bass Global, Inc, Fort Myers, FL

AMWA’s Third Annual Meeting of Medical Writing Executives Tackles 
Value, Leadership, Change, Recruitment, and Retention

AMWA NEWS

• Alnylam Pharmaceuticals
• American Medical Writers Association
• Astellas Pharma Global Development, Inc.
• Bass Global, Inc.
• Bioforum Group
• Boehringer Ingelheim Pharma GmbH & Co. KG
• Bristol Myers Squibb
• Certara Synchrogenix
• Eli Lilly and Company
• Encore Biomedical Communications LLC
• Endo Pharmaceuticals
• Genmab
• Gilead Sciences, Inc.
• Greenwich Biosciences, Inc.
• Harpoon Therapeutics
• ICON plc
• Janssen R&D, Johnson & Johnson
• Karen L. Fink Medical and Regulatory Writing
• Merck & Co., Inc.
• Moderna, Inc.
• Novartis Pharmaceuticals
• PAREXEL
• Pfizer Inc.
• Praxis Precision Medicines
• Regeneron Pharmaceuticals, Inc.
• Roche Diagnostics
• RRD International, LLC
• Sarepta Therapeutics, Inc.
• Seqirus
• Syneos Health
• Synterex, Inc.
• Takeda Pharmaceutical Company Limited
• Trilogy Writing & Consulting
• Ultragenyx Pharmaceutical Inc.
• Whitsell Innovations, Inc.

Table. 2021 Medical Writing Executives Forum Attendee 
Company List

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AMWAJournal.org     35AMWA’s Third Annual Meeting of Medical Writing Executives

REVIEWING DATA/INSIGHTS FROM THE VALUE OF 
MEDICAL WRITING SURVEYS
AMWA formed a working group in 2021 to work toward 

defining and quantifying the value of regulatory medi-

cal writers. The Value of Medical Writing Working Group 

includes 3 subgroups: Engagement with Regulatory Health 

Authorities, Survey Development, and Literature Search 

and Assessment of the AMWA Training Outline and the DIA 

Competency Model. The efforts of the working group are 

ongoing, and initial findings have been reported.1-3

 During the 2021 AMWA Medical Writing Executives 

Forum, the participants in this breakout group discussed 

several topics based on the working group’s efforts to date.

Using The Data
A key finding of the working group’s efforts that participants 

in this breakout group discussed is the need to educate 

others about the value of medical writers in the regulatory 

field. Their recommendations included

• Leveraging the working group’s findings to start con-

versations with company managers and encourage 

investment in the medical writing team.

• Emphasizing to all stakeholders involved in the medi-

cal writing process that regulators prefer brevity; larger 

documents are not necessarily better.

• Educating subject matter experts, who are stakeholders 

and contributors to the medical communication pro-

cess (eg, biostatisticians, clinicians, pharmacovigilance 

physicians), that medical writers are an important part 

of the regulatory communication process.

Data That Were Unexpected/Surprising
The survey of regulatory medical writers conducted by the 

working group found that many regulatory medical writ-

ers feel undervalued. The working group provided insight 

into how companies that employ regulatory medical writ-

ers can promote professional growth and job satisfaction. 

Participants in this breakout group recommended increasing 

opportunities for medical writers to gain soft skills training, 

providing more opportunities for medical writers to grow 

into leadership roles, and exploring mentorship programs to 

promote collaboration and leadership.

 The breakout group participants noted that today’s med-

ical writers seem to be more willing to take the lead, which is 

an asset to help improve collaboration with other stakeholders 

in the communication process. Participants noted the ability 

to collaborate is as important as the ability to lead.

 Although not surprising, participants in this breakout 

group acknowledged that in the United States and some (but 

not all) other countries, women form the majority in the field 

of medical writing. The group proposed an effort to explore 

what may be holding men back from pursuing a career in 

medical writing and how they might be encouraged to do so.

Communicating The Data
Initial findings of the working group have been published 

in the AMWA Journal 1-3 and presented at the AMWA 2021 

Medical Writing & Communication Conference. Efforts are 

underway to also present findings of the working group 

at upcoming meetings of the European Medical Writers 

Association and the DIA, as well as at the AMWA 2022 

Medical Writing & Communication Conference 

 Acknowledging the growing need for qualified, profes-

sional medical writers, participants in this breakout group 

proposed reaching out to high schools, colleges, and uni-

versities to increase awareness about the medical writing 

profession and encourage students to consider a career in 

medical writing.

Currently Missing From The Value Story
Participants in the breakout group expressed that a granular 

definition of quality is needed to provide a uniform and con-

sistent target for all stakeholders to expect, measure against, 

and achieve. The breakout group thought it would be espe-

cially helpful for managers to know how quality affects the 

return on investment in medical writing in terms of the time, 

money, and resources invested. Understanding the dynam-

ics of employing staff compared with contract  

or freelance medical writers would also be helpful for deci-

sion makers.

DEVELOPING THE NEXT GENERATION OF LEADERS 
FOR MEDICAL WRITING TEAMS
The dynamics of leadership and the characteristics of an effec-

tive leader are continually evolving. This breakout group con-

sidered the skills, tools, and opportunities that will likely be 

needed by tomorrow’s leaders of medical writing teams.

Key Skills for Tomorrow’s Aspiring Leaders
The breakout participants acknowledged that not all medi-

cal writers want to become leaders in the traditional sense 

of managing others, yet they agreed that all medical writers, 

regardless of their aspirations, will benefit from mastering 

the soft skills required to lead as an individual expert con-

tributor. These soft skills include

• Flexibility

• Problem solving

• Collaboration

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AMWAJournal.org     36AMWA’s Third Annual Meeting of Medical Writing Executives

• Diplomacy

• Curiosity

• Agility

• Resilience

• Project management

 An ideal way for someone to learn effective leadership 

skills is by observing an effective leader. Seeing firsthand 

what an effective leader does to inspire and guide their team 

and how they respond to challenges, provides aspiring lead-

ers with the opportunity to see the key skills they need in 

action. The next step is to give aspiring leaders the opportu-

nity to practice and internalize these newly learned skills in 

a safe environment in which they can challenge themselves, 

make mistakes, and build confidence.

Tools for Tomorrow’s Aspiring Leaders
For medical writers who aspire to someday lead others, 

participants in this breakout identified several tools they 

will need to lead their regulatory medical writing teams. At 

the top of the list, leaders must have the trust of their team 

members, the ability to communicate with them clearly and 

directly, and leadership consistency. Leaders of medical 

writing teams must be able to provide positive feedback  

and reinforcement, ideally in the moment when such feed-

back is appropriate, and constructive feedback discretely 

when warranted.

 Making sure everyone on the team has a voice and uses 

their voice to express their ideas, needs, and opinions is 

another important tool for team leaders. Being flexible with 

how people work can empower medical writers on the team 

to optimize their productivity while reducing work- and/or 

life-related stressors.

 Autonomy is another important tool identified by the 

breakout participants. Team members should be given con-

trol of their own work when possible. Ownership—even of 

just a small piece of a larger project—fosters engagement.

Opportunities for Tomorrow’s Aspiring Leaders
Today’s leaders must make clear where opportunities for 

leadership training can be found within the organization, 

and reward those who are curious and aspire to become 

leaders by facilitating such training. Those who are train-

ing aspiring leaders should get to know the individuals they 

are training and their desired career paths so they can be 

guided appropriately. Mentorship is a powerful teaching 

tool, enabling aspiring leaders to learn by example.

 Leadership desires may vary, and it is important for 

today’s leaders to keep this in mind. Whereas, some medi-

cal writers aspire to a management track, others may aspire 

to leadership in a technical track. Likewise, a career path is 

different from a development path, and it is important for 

today’s leaders to know the difference when providing guid-

ance to tomorrow’s aspiring leaders.

CHANGES IN THE MEDICAL WRITING ENVIRONMENT
In this breakout group, participants identified changes that 

are currently taking place in the medical writing environment 

and discussed what medical writers can do address them. 

They grouped the changes taking place into 3 categories:

• Financial demands

• Technological innovations

• Team challenges

Financial Demands
Breakout group participants noted the current demand for 

cost savings in their medical writing departments, which 

affects internal and external resource utilization. There is  

an added burden of internal resource management and 

oversight.

 Increasing demands on the costs associated with man-

aging outsourced medical writers includes demanding that 

outsourced medical writers self-manage their associated 

costs. On the staff side, there is currently a salary competi-

tion taking place in which managers are challenged to  

keep costs down while paying appropriately for qualified 

staff resources.

Technological Innovations
Technology enables medical writing teams to eliminate 

some of the more mundane tasks and increase efficiency, 

especially in regulatory writing with the use of standardized 

templates. Technology has changed the way teams interact 

with medical writers and not all of it is positive or useful. 

Overly customized software can be well intentioned but 

overly burdensome for medical writers to use. It is incum-

bent upon managers to determine the level of technology 

that best meets the needs of the team and the work environ-

ment without overcomplicating processes.

 Although it may seem that standardized technologies 

cannot be applied to the unique requirements of rare dis-

ease indications, a similarly unique or specialized use of 

technology may not be required.

 The breakout group participants also discussed the 

differences between logic-based and artificial intelli-

gence-based technologies and agreed that more informa-

tion is needed to choose the appropriately technology for a 

particular application or team.

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AMWAJournal.org     37AMWA’s Third Annual Meeting of Medical Writing Executives

Team Challenges
Challenges experienced by medical writing teams add 

expense and time to a project. Templates can help stream-

line these processes, provided they are not too individu-

alized. Regulatory medical writers must keep in mind that 

they are writing for a health authority audience, not for sub-

ject matter experts.

 Two major challenges faced by regulatory medical writ-

ers concern document brevity and timelines. Regulatory 

reviewers have said they want documents to be clearer and 

more concise, but medical writers typically lack the author-

ity to impress this upon other stakeholders in the docu-

ment development process. Verbose documents also take 

more time to produce, which contributes somewhat, but not 

solely, to the second challenge of timelines. Medical writ-

ers rarely have influence over the timelines that drive their 

work, and when pushed to meet timelines that may be unre-

alistic to the task, can experience burnout and possibly even 

stress-related injuries.

What Medical Writers Can Do
The breakout group participants identified ways in which 

medical writers can address these changes taking place in 

the regulatory environment. These include

• Clarifying the role of medical writers to stakeholders, 

some of whom who simply want scribes.

• Elevating the visibility of the medical writer as a vital 

member of the team.

• Engaging medical writers in setting timelines and 

giving them confidence and authority to push back 

against unrealistic deadlines.

• Conducting after-action reviews with the team to 

identify what went right and discuss opportunities for 

improvement.

• Highlighting transparency initiatives to help with stan-

dardization, use of templates, and leaner authoring.

RECRUITING AND RETAINING MEDICAL WRITERS
Participants in this breakout group discussed turnover rates, 

the key attributes to look for when recruiting medical writ-

ers beyond writing skill, interacting with recruiters, training 

programs, and methods for recognizing, remunerating, and 

retaining top talent.

Turnover
Some companies have experienced attrition exceeding 

the rate of onboarding new employees, with turnover rates 

among medical writers reportedly as high as 30%. Burnout 

is a large contributor to turnover, with some medical  

writers moving to freelance work to achieve a better work-

life balance while others fear moving out of the company 

environment due to stability. Another contributor to turn-

over is the disparity in position leveling across companies, 

which may make it enticing for staff medical writers to move 

from a larger pharmaceutical company to a smaller biotech-

nology company that may be recruiting at higher positions 

and offering higher salaries.

Key Attributes to Look for When Hiring Medical Writers
Beyond writing skill, the breakout group participants identi-

fied a range of key attributes for hiring managers to look for 

when recruiting medical writers:

• Ability to work remotely

• Well-rounded document experience

• Contribution to a diverse team

• Innovative thinking, particularly concerning  

adoption of automation

• Emotional intelligence

 During the hiring process, some companies engage 

panels to interview candidates, which can be intimidat-

ing and time consuming. Other companies have consider-

ably more expedited interviewing processes. The interview 

is especially important because it provides candidates an 

opportunity to talk the talk and show what they truly know.

 Many companies are focused on ensuring diverse slates 

of candidates for open positions as well as diverse interview 

panels. Building diversity strengthens the quality of a good 

medical writing team and can take the team to new levels of 

innovation including being able to manage challenges from 

different perspectives.

 Companies that require writing tests vary between 

in-person and automated platforms. It was noted that  

writing tests can be perceived as demeaning by more-expe-

rienced medical writers who may subsequently decline and 

be lost as potential candidates. Developing an experience 

grid may make it easier for hiring managers to determine 

and compare candidates’ true experience rather  

than reviewing CVs.

Interacting With Recruiters
Participants agreed that personal recommendations and 

referrals are best for identifying qualified candidates. 

Companies have had varying degrees of success using inter-

nal and external recruiters and have found that recruiters 

themselves need training on the skillsets required to be a 

successful medical writer.

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AMWAJournal.org     38AMWA’s Third Annual Meeting of Medical Writing Executives

Training
Several breakout group participants reported that their 
company provides training programs in the form of appren-
ticeships, writing academies, and summer internships. 
University training programs are needed, as well as efforts to 
educate students about careers in medical writing.

Retaining Top Talent
Bonuses, career ladders, and work-life balance are among 
the tools companies can use to retain top medical writ-
ing talent. This may include monetary and gift award pro-
grams, retention bonuses, and offering clear development 
and leadership opportunities. It can be challenging when an 
employee’s drive for advancement exceeds the company’s 
established processes and timelines for promotion.
 Work-life balance is an important consideration for staff 
medical writers and may include opportunities for part-
time work and personal time off. In the European Union, 
it was suggested that most regulatory medical writers are 
part-time. As a result, companies and staff must adapt to 
maintain workflow and timelines, such as document sharing 
among team members. Having a reliable group of backup 
writers can also help.

LEADING TEAMS DURING A TIME OF CONSTANT 
STATE OF FLUX AND AMBIGUITY
Participants in this breakout group discussed the role of 
team leaders in managing change within their medical writ-
ing departments, and how managers can help affect change 
within their teams and with outside vendors.

Managing Change
Change is constant. Critical factors in managing change are 
transparency, community, and trust. Managers of medical 
writing teams can best manage change by being upfront and 
honest, present and calm, transparent, and realistic (ie, not 
superficially or unrealistically positive). Teams tend to absorb 
and then radiate the mood of their environment, whether that 
mood is calm or negative. Managers should lead by example 
at all times and especially when times are tough.
 Team managers should be honest about what they know 
and do not know to avoid team members thinking that infor-
mation is being kept from them. It is easier to get a team to 
embrace, or at least accept, change when they understand 
why it is needed or happening. It can be helpful to discuss 
the opportunities that change may bring. However, change 
should not necessarily be normalized, such as when a key 
support structure is no longer in place. The COVID-19 pan-
demic provides an example of this, when schools were no 
longer meeting in person and employees began working from 
home with their children learning from home.

Affecting Change
Affecting change within a medical writing team is challeng-
ing and time consuming for the team manager. Managers 
must address the concerns, expectations, and needs of the 
team members and implement the necessary changes while 
also maintaining the team’s focus on the project tasks, goals, 
and timelines at hand. Providing the information medi-
cal writing teams need to understand and be a part of the 
change will help suppress the speculation and rumor that 
might otherwise persist. Engaging the assistance and sup-
port of Human Resources when relevant can also be helpful.
 Managers must be cognizant of the impact changes can 
have on team members. For example, working from home 
during the COVID-19 pandemic fostered greater productiv-
ity, but it also led to higher rates of burnout as staff found 
themselves working longer hours. Some breakout group 
participants said they provide opportunities for their team 
members to recharge, including offering mental health days 
that can be branded as “Days of Reflection” or “Curiosity 
Days.” Change is not forever, and the medical writing team 
may be reassured to know that a company’s or a depart-
ment’s response to change can evolve if something does not 
work as well as planned.
 Change can also be difficult for vendors, whom some 
perceive as threats rather than members of the team. It is 
important to match the expectations of the team and the 
vendor at the start of the relationship and ensure goals are 
aligned.
 Some participants in the breakout group noted that they 
invite their contract medical writers to team meetings to 
foster a collegial atmosphere built on familiarity, trust, and 
cooperation. Connecting vendor members of the team with 
sponsor members can help build and strengthen these rela-
tionships. In dealing with vendors during times of change, 

once again, communication is the key to success.

Author declaration and disclosures: The author notes no com-
mercial associations that may pose a conflict of interest in rela-
tion to this article.

Author contact: brianbass@bassglobalinc.com

References
1.  Harris D, James LC, Klapproth JF, Bass B, Winnier AR. Optimizing 

the value of regulatory medical writers. AMWA J. 2021;36(4): 
138-144.

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

3.  Harris D, Tyrrell C, Myers A, Carr C, Fink KL. Value of medical 
writing: the regulatory writer’s perspective. AMWA J. 2021;36(4): 
152-158.

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