





































 V38 N2 / 2023 

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

AMWAJournal.org     22

ABSTRACT 
A high-performing medical writing team begins and ends 
with talented writers, editors, and leaders who understand 
their mission and their business. A panel of writers com-
prising the authors convened virtually on October 28, 2021, 
at the American Medical Writers Association National 
Conference to discuss this topic. The topics of value prop-
osition and business models, communication and leader-
ship, and financial acumen and corporate responsibility will 
be reprised in this 3-part series, along with thoughts from 
the authors looking to the future of the business of medical 
writing, including what we can do in the medical writing 
community to introduce these topics earlier in the medical 
writing career path.

A high-performing medical writing team begins and ends 
with talented writers, editors, and leaders who understand 
their mission and their business: the value proposition, the 
finances that drive strategy and decision-making, the finan-
cial goals, and effective communication. To execute the 
organization’s goals, leaders must orchestrate resources and 
often have to balance dynamic variables including budgets 
and governance that provide bidirectional input into the 
business strategy.1

 A panel of writers comprising the authors convened vir-
tually on October 28, 2021, at the American Medical Writers 
Association (AMWA) National Conference to discuss this 
topic.2 The authors felt the topic was apropos given that they 
themselves have experienced—and often hear from other 
writers—that business-related topics in medical writing are 
learned on the job, mid- to late-career, when writers are 
expected to be able to analyze and synthesize knowledge 
across the business portfolio of assets,1 often in high-stress 
and rushed circumstances without the benefit of  
prior observation.
 The panel members shared their own journeys as busi-
ness leaders and the methods they used to strengthen the 
business acumen of their teams. Discussion topics included 

identifying and defining a compelling value proposition; 
models to teach financial understanding and oversight; 
business leadership skills, anchored by simple, clear com-
munication, to keep teams motivated and engaged with 
their mission; collecting data to measure the effectiveness 
of teams and prioritize and allocate resources in support of 
business goals; and communication styles to support criti-
cal business drivers such as team focus and engagement.
 The topics of value proposition and business models, 
communication and leadership, and financial acumen and 
corporate responsibility will be reprised in this 3-part series, 
along with thoughts from the authors looking to the future 
of the business of medical writing, including what we can do 
in the medical writing community to introduce these topics 
earlier in the medical writing career path.
 The authors’ collective experience comprises the follow-
ing medical writing work environments:

• Freelance business
• Small business/vendor
• Department leadership of small- to mid-size biotech 

company and large-sized pharmaceutical company

 The moderator’s (Joan Affleck - JA) prompt is provided 
for each topic, followed by each perspective on the topic. In 
some cases, text from the session has been paraphrased for 
optimal clarity in this medium.

DEFINING VALUE
Value Proposition
JA: Let’s start today with a fundamental question for each 
of us. We often hear the buzz phrase “value proposition.” 
That’s the idea that there’s a service or product that is attrac-
tive and valuable to a customer or end user.1 In my regu-
latory medical writing department, our value proposition, 
in brief, is that we develop documentation to support the 
research and development objectives of a much larger  
organization. So, what does your value proposition mean 
in your organizations, and why is your value proposition 
important in the big picture?

TOPICAL FEATURE

PART 1 IN A 3-PART SERIES

The Business of Medical Writing: Understanding the Value 
Proposition and Successful Business Models
Joan Affleck, MBA1; Dominic De Bellis, PhD1; Brian Bass, MWC2; and Jeanette M. Towles, MA, RAC-Drugs3/ 
1Merck & Co, Inc, Rahway, NJ; 2Bass Global, Inc, Fort Myers, FL; 3Synterex, Inc, Dedham, MA

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AMWAJournal.org     23Understanding the Value Proposition and Successful Business Models

Jeanette, could you start?

Jeanette Towles (JT): I’ll start by saying what our value 
proposition is: “We apply our years of experience and cur-
rent regulatory and technical knowledge to help deliver 
important new therapies to patients in an expedient 
manner. We are a best-in-class firm and take pride in our 
operational excellence.” For me, a value proposition means: 
1) what we bring uniquely to the table if a customer wants 
to work with our company; 2) what we stand for; 3) what 
challenges we solve; and 4) what gains we offer (Figure 1). 
Hopefully, by convincing the customer [that] we can use our 
years of experience, we make the sale—and the company 
not only chooses us but also keeps coming back to us. We 
strive to leave the impression with our customers that we 
should really be their go-to to get things done. This proposi-
tion also translates well to the in-house setting.

JA: Dom, is that something that resonates with you, being 
in Big Pharma?

Dominic De Bellis (DD): Being the go-to to get things done 
always resonates with me! It’s important to understand that, 
regardless of whether [you’re] independent or in-house, your 
goal is really the same: to provide [an] excellent product to 
the client. For the freelancer, that will be another organiza-
tion, and for the in-house medical writer, that’s your clinical 
team or your document development team. You’re a smaller 
piece of a bigger organization if you are in-house, but the 
requirements from the writers’ or teams’ perspective are very 
similar; it is a question of how you manage the team to affect 
the success of the document as a whole.

JA: And Brian, in the freelance context, what’s that like?

Brian Bass (BB): In the freelance world, value is para-
mount. If we are not bringing value to the table, we are not 
going to be able to make a living wage and ultimately keep 
our clients. The value proposition from the freelance  
standpoint is to remember that first and foremost we are 
problem-solvers. Clients come to freelancers when they do 
not have someone on staff (or another freelancer they have 
worked with) who can get the job done. Especially when 
clients reach out to you as a new freelancer, they are coming 
to you with a problem, and our job is to solve that problem. 
We happen to do it by medical writing, but what we need 
to understand is what is driving the client’s need to reach 
out to us. They need us to be confident, and they need to 
be confident in us. They need to know that we are going to 
make their job easier. And that’s how freelancers ultimately 
put forth their value in making their clients’ lives easier.

JA: Have any of you run into challenges with defining or 
clarifying that value proposition with your customers?  
Any situations [in which] they didn’t quite understand 
what it was you were bringing to the table or perhaps  
misinterpreted it?

JT: This comes up fairly often, to be honest—and earlier 
in my career this was surprising, but it no longer is. I enter 
each client relationship and document saying I need to 
prove myself to this client continually for them to keep 
coming back to me—for example not only that we can exe-
cute a clinical study report but also that we can execute a 
supplemental new drug application in its entirety. Needs, 
requests, and the regulatory environment change over 
time, so I have personally faced continual challenges. I also 
worked with an organization that was in such a funding sit-
uation that we kept getting questions about every dollar and Figure 1. Defining a value proposition.

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AMWAJournal.org     24Understanding the Value Proposition and Successful Business Models

cent. So, I said to myself that I need to have a conversation 
with this customer to walk them through what goes into this 
work. That exercise ended up building trust; they came to 
understand how many hours went toward producing a par-
ticular type of document and all the steps that went into it. 
In the long run, we received fewer questions, and the tone 
shifted to a more trusting partnership. If you are having 
challenges, it is worth having a conversation about them.

JA: Interesting that trust is something we don’t usually think 
of as being part of a business plan—but you and Brian have 
both pointed out it most definitely is: trust and confidence. 

BB: I find that clients often don’t realize what I strive to 
deliver to them makes their job easier because I anticipate 
where other freelancers go wrong: not staying in touch and 
on top of projects, calling at the last minute to say they are 
behind schedule, things like that. All of those mistakes really 
are so easy to avoid if you focus on them. But many clients 
don’t expect that, and they are naturally very pleased. As 
a matter of fact, I just received an email this morning from 
a client who said, “you are everything that so-and-so said 
you were.” And to me, that is the proof of why I work hard to 
deliver that value proposition.

JA: Dom, when you are embedded in a company, do you 
still have the same challenge—do you have to keep proving 
yourself to customers?

DD: It’s very much the same, you are only as good as your 
last document. That maxim holds true in-house in the same 
way. The problems we solve may differ: we may be more 
focused on navigating complex internal processes on behalf 
of the team, we may be more aware of certain regulations 
that may be more relevant, and we have to keep our finger 
on the pulse of those changes. But from a document devel-
opment and writing standpoint, it’s the same thing: quality 
is expected, and we need to provide that level of service. I 
think of our teams as our clients, so there’s “client educa-
tion” to get the team to understand what’s involved in the 
work you are doing. Everyone learns to write, which is won-
derful, but not everyone writes the way we need them to 

write for a particular document or in a way that’s applicable 
to the audience you’re writing for. There are many nuances 
to the craft, and it’s necessary for us to explain that to the 
client or team as we build trust and get them to see the 
value proposition.

BUSINESS MODELS
JA: OK, so you’ve got your value proposition—this is the 
value we bring. But then you have to have a way to oper-
ationalize that—you’ve got to have a business model that 
hooks up with your value proposition. Let’s talk a little bit 
about the kind of business model you have today. Is it a 
group, one person, [a] freelancer, in-house employees? 
What are some factors you consider as a business leader 
when you’re building a business model? Brian?

BB: I was an independent freelancer for the first 15 years or 
so of my business. Since the early 2000s, I have been bring-
ing in other freelancers who subcontract with me, includ-
ing both medical writers and medical editors. My business 
model had to evolve because I was no longer just respon-
sible for paying attention to how I delivered for my clients 
in terms of the value I bring to the table. I had to make sure 
that the other people on my team understand that as well 
and take that to heart as much as I do. Therein lies the chal-
lenge for any manager; even though I’m not operating a big 
department within a large corporation, I am still operating 
my own department. I am ultimately responsible for any 
project and any person on my team who is working on it. So, 
I had to adapt my model to consider the amount of time it 
takes me to manage the projects, to work behind the scenes 
with the writers and editors to make sure they are deliver-
ing the way I need them to deliver. One way that I am per-
haps a little unique compared with other freelancers who 
bring in subcontractors is that the people on my team are as 
qualified if not even more qualified than I am, so they are all 
at the top of their craft. I find that by starting with the very 
best people, it takes away some of the challenges you might 
run into with people who have less experience and are still 
learning their way through the processes. That is what has 
been working for me.

JA: I like how you talked about thinking of your group as your 
own department because I do just the opposite. I say, okay, I 
have a department within a large corporation, but I think of 
it as my own business. So, I like that cross-pollination.

BB: Clearly it must work if we are both approaching it that 
way; we are doing the same thing, just from a different 
direction!

Trust is something we don’t 
usually think of as being  
part of a business plan,  
but it most definitely is:  

trust and confidence.

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AMWAJournal.org     25Understanding the Value Proposition and Successful Business Models

JA: Exactly, and we are borrowing across each other’s 
worlds! Jeanette, I bet that with your value proposition and 
that quality element, you, too, must spend a fair amount of 
time in your business model making sure that other people 
who are delivering on behalf of your company’s name are 
doing it at the very highest level and in the way you want 
them to deliver. Is that true?

JT: That is absolutely right. “Operational excellence” is part 
of our pitch, and we make sure we deliver on it. Similar to 
what Brian was saying, if you are going to pitch yourself as 
a best-in-class firm, you really need people who have the 
experience behind that. And not just on paper—we admin-
ister a test to make sure, pragmatically speaking, that they 
live up to the basic standards, that they are focusing on the 
right things if they have a short period of time to do some-
thing. Something we introduced recently was a pathway 
for people who don’t have as much experience in indus-
try; and the reason we did that is two-fold: 1) our resource 
pool is finite by nature, which COVID emphasized because 
there was a lot of competition for really great talent; and 2) 
a sense of corporate responsibility to help people coming 
in at a lower level to work up to where they could eventu-
ally do tasks on their own. So, we created a Medical Writing 
Operations group, and we have folks come in through that 
pathway, learn what it’s like to be in this function, learn what 
it’s like to manage a project day-to-day, and approach it that 
way. By learning the basics in a lower-pressure environment, 
they have the opportunity to really learn and get exposure 
to items so they could eventually live up to those same stan-
dards that we have to offer on the medical writing side.

JA: It's really interesting that Brian and Jeanette both 
touched on resourcing; the care, feeding, and development 
of medical writers and medical communicators; and the 
search for top talent all as part of the business model. Dom, 
is it the same in your space?

DD: I may be repeating myself, but yes, it is in the sense that 
we also need top people here on our team to do the same 
kind of work. The finite resource pool is a known challenge 
for all of us; however, we have to provide the right environ-
ment—whether it be training, resources, infrastructure, 
or established process: these are the things we offer as an 
in-house environment versus someone who may start out 
freelancing independently or work with someone more 
established. It’s the same need for personnel, and the one 
difference we have in-house is we have the resources avail-
able to us to develop and put plans in place or put opportu-
nities in front of people for them to have a broad experience 
and to become marketable across the industry in medical 

writing, rather than to become pigeonholed in one particu-
lar skill set or document type. We need the same high-qual-
ity people. We may have an advantage in what we can offer 
in terms of training people and developing them, but again, 
we cannot do that at the expense of quality or the work that 
has to be done, so it’s a delicate balance.

LOOKING TOWARD THE FUTURE
As the moderator of this AMWA Business of Medical Writing 
discussion noted, this panel was an initial dialogue meant 
to “kick off a broader discussion of the many aspects of 
business leadership as it applies to our work as medical 
communicators.”2

 Learning about business is part of regular training in 
adjacent fields in industry, for example, for regulatory affairs 
professionals (Figure 2).1,3 The business acumen domain of 
the Regulatory Affairs Professionals Society (RAPS) com-
petency framework, for example, as a cross-functional 
domain, is characterized as representing “knowledge con-
tent that is broadly relevant to those employed as regulatory 
affairs professionals.”3 The domain descriptor is the “ability 
to leverage systems and processes to successfully operate a 
regulatory function to manage product and organizational 
risk,” and the topics covered include industry-specific, oper-
ational, project management, quality management, and 
continuous improvement knowledge.

 The similarity of the regulatory framework’s business 
domain description to what medical writers encounter 
in their daily job function—for example, leveraging sys-
tems and processes to manage risk—is striking. What is 

Figure 2. Regulatory professional competency framework, including 
business acumen domain. Source: Regulatory Affairs Professional Society 
(RAPS). Regulatory Competency Framework Model Concept. 2021.3

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AMWAJournal.org     26Understanding the Value Proposition and Successful Business Models

equally remarkable is that the business domain is consid-
ered “broadly relevant” to all in the job function—not just 
for those considering being in a management position. In 
this framework, leadership and ethics are “the foundational 
domains, providing the underpinning for professional suc-
cess” and are considered as additional skills separate from 
the business acumen domain, whereas the panelists for the 
Business of Medical Writing discussion considered them 
within the same overall umbrella of business skills but 
placed them with the same level of importance in terms of 
contribution to overall professionalism.
 Although the DIA medical writing competency model 
references the need to deliver to business objectives and 
interact with business partners to meet customer needs as 
part of the writer’s regular functions, tasks, and activities,4-6 

it is not clear what business literacy skills medical writers 
should acquire to prepare them for such interactions. In 
fact, this model not only prescribes key activities like map-
ping of a “product’s key messages to customer needs, crit-
ical success factors, medical/scientific objectives, clinical 
plans, and data results across phases of development and 
global regions,” but assumes that the writer is familiar with 
how to create important business documents like a business 
continuity plan. So, the question remains—what content 
from these disparate sources is most relevant in the medical 
writing context?
 Furthermore, managers of medical writers are expected 
to understand many tenets of business interconnectivity, 
management principles, innovative concepts and organiza-
tional theories, finance and budget management, resource 
and performance management, vendor management, stra-
tegic planning, change management, metrics, and more.6 
The AMWA Recommended Training Outline for Regulatory 
Writers, although acknowledging that the skills in the out-
line are but some of the skills and proficiencies needed for 
professional success and are subject to regular review and 
update, similarly does not distinguish business knowledge 
as a separate training topic and broadly covers the topics of 
analytical skills, self-management, people skills, and per-
sonal development across 2 primary categories that make 
up the competency along with a third category for docu-
ment-specific training.7 Having a comprehensive business 
curriculum would benefit the writer in these circumstances 
toward the goal of developing a strategic mindset while 
learning fundamental business topics.

 Realizing a value proposition that solidly complements 
the now-accepted medical writing competencies requires a 
pathway whereby medical writers can readily learn the skills 
needed to demonstrate leadership while also participating 
in decision-making activities earlier in their careers. Along 
with such a pathway is the need to develop the infrastruc-
ture of their departments that supports the development of 
business-savvy medical communicators.
 The panelists of the Business of Medical Writing discus-
sion (the authors) hope to use the momentum of the inter-
est and enthusiasm of the medical writing community on 
this topic from the national conference to propel our com-
munity forward into further discussions about how business 
literacy can be incorporated into our training curricula and 
our practices and processes—and ultimately, perhaps our 
competency frameworks—so that it becomes an intentional 
element of training for all writers, enabling them to best 
support the needs of their organizations and businesses.

Author declaration and disclosures: J. Affleck and D. De Bellis 
are employed by Merck & Co, Inc, and are shareholders. B. Bass 
and J. Towles note no commercial associations that may pose a 
conflict of interest in relation to this article.

Author contact: jtowles@synterex.com

References
1.  Towles J. The business of medical writing: the small business 

perspective. Presented at: American Medical Writers Association 
Indiana Chapter conference [virtual]; April 29, 2022.

2.  American Medical Writers Association (AMWA). National 
Conference Brochure. AMWA; 2021. Accessed July 03, 2022. 
https://cdn.ymaws.com/www.amwa.org/resource/resmgr/
conference/2021/2021amwa_conf_program_june15.pdf

3.  Regulatory Affairs Professional Society (RAPS). Regulatory 
Competency Framework Model Concept. RAPS; 2021.

4.  Clemow DB, the Drug Information Association Medical Writing 
Special Interest Area Community Competency Model Working 
Group. Pharmaceutical medical writing competency model. 
AMWA J. 2011;26(2):71.

5.  Clemow DB, Wagner B, Marshallsay C, et al. Medical 
Writing Competency Model—section 1: functions, tasks, 
and activities. Ther Innov Regul Sci. 2018;52(1):70-77. doi: 
10.1177/2168479017721585

6.  Clemow DB, Wagner B, Marshallsay C, et al. Medical Writing 
Competency Model—section 2: knowledge, skills, abilities, 
and behaviors. Ther Innov Regul Sci. 2018;52(1):78-88. doi: 
10.1177/2168479017723680

7.  Yih L, Alexander LL. Recommended training outline for 
regulatory writers. American Medical Writers Association 
(AMWA); 2020. Accessed March 3, 2023. https://info.amwa.org/
hubfs/Offers/regulatory-writer-training%20ebook/regulatory-
writer-training.pdf

http://www.amwajournal.org
https://cdn.ymaws.com/www.amwa.org/resource/resmgr/conference/2021/2021amwa_conf_program_june15.pdf
https://cdn.ymaws.com/www.amwa.org/resource/resmgr/conference/2021/2021amwa_conf_program_june15.pdf
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https://info.amwa.org/hubfs/Offers/regulatory-writer-training%20ebook/regulatory-writer-training.pdf
https://info.amwa.org/hubfs/Offers/regulatory-writer-training%20ebook/regulatory-writer-training.pdf



