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ABSTRACT
An expanding need for clinical documentation and regulatory 

health authority interactions during drug development has 

drawn increased attention to the role of the regulatory medi-

cal writer. This role is frequently misunderstood and poorly rec-

ognized. The American Medical Writers Association (AMWA) 

formed a working group in 2020 dedicated to defining the value 

that regulatory medical writers contribute. The purpose of this 

article is to demonstrate the value that regulatory medical writ-

ers bring to the drug development and approval processes and 

to explore the ways in which efficiencies in regulatory writing 

can be increased. Current models for success provide guidance 

on training to help medical writers achieve their full potential, 

but obstacles and barriers to medical writing efficiency and 

document quality remain. Surveys developed by the AMWA 

working group revealed that (1) regulators who review clinical 

documents believed that regulatory writers improve document 

quality and (2) writers are frequently recognized for leadership 

and collaboration. Maximizing medical writing value requires 

thoughtful leadership and investment in training that includes 

both technical knowledge and soft-skill proficiency.

INTRODUCTION
Expansion of the biopharmaceutical industry has given rise to 

many jobs with very specialized skills sets supporting both the 

conducting and reporting of clinical trials. One of these spe-

cialized jobs is that of the medical writer. There are now several 

types of medical writers: those who focus on clinical data  

publication writing, those who support medical education  

and conference materials, and those who primarily prepare 

regulatory documentation supporting ongoing clinical trials 

(eg, clinical study protocols, investigator brochures, investi-

gational new drug [IND] applications) and the reporting and 

submission of trial results to regulatory agencies (eg, clinical 

study reports and Module 2 clinical summary documents for 

marketing applications). Writers in this latter category have 

been termed “clinical writers,” “regulatory writers,” or “clinical–

regulatory writers,” and exploration of the value of their role is 

the focus of this article. For purposes of the current discussion, 

these writers will be referred to as regulatory writers.

 Companies engaged in the development of new medicines 

have a high need for expert communicators and devote sub-

stantial budgets to ensuring that documentation supporting 

clinical trials and regulatory submissions is accurate and of 

high quality. However, because company structures and team 

structures vary significantly, expectations of the role of the reg-

ulatory writer may also vary. Full exploitation and harnessing 

of the writer’s skills and value requires members of the clinical 

project team to have a common understanding of the writer’s 

role. As this proposition regarding the value of the regulatory 

writer has become a prominent topic in the medical writing 

community, the American Medical Writers Association (AMWA) 

has formed a working group focused on understanding and 

communicating the value that regulatory writers bring to proj-

ect teams. The remit of this working group included develop-

ing a series of surveys designed to gather information about 

the value that regulatory writers represent, as well as a thor-

ough review of the literature to identify articles that address this 

topic. This article aims to demonstrate the value that regulatory 

writers bring to the drug development and approval process 

and to explore both common obstacles to efficiency and ways 

we can increase efficiencies in regulatory writing, including 

through improved training of medical writers industry wide.

CURRENT MODELS FOR SUCCESS
A Medical Writing Competency Model was developed by an 

industry-wide group of medical writers to provide guidance 

Dylan Harris,1 Lisa Chamberlain James,2 Julia Forjanic Klapproth,3 Brian Bass,4 and Angela Russell 
Winnier,5 on behalf of the AMWA Value of Medical Writing Working Group / 1Takeda Pharmaceutical 
Company Limited, Lexington, MA, USA; 2Trilogy Writing and Consulting, Cambridge, United Kingdom; 
3Trilogy Writing and Consulting, Frankfurt, Germany; 4Bass Global Inc, Fort Myers, FL, USA; 5Pfizer,  
The Woodlands, TX, USA

Optimizing the Value of Regulatory  
Medical Writers



      AMWA Journal / V36 N4 / 2021 / amwa.org    139

on how to assure quality and consistency in the medical writ-

ing function.1,2 It also serves as a tool to describe the value and 

contributions of medical writers to drug development and 

medical communications. The model defines the essential 

knowledge, skills, abilities, and behaviors (KSABs) necessary 

for medical writing competency. It is purposefully designed to 

include the scope and breadth of the medical writing profes-

sion, and it is applicable to both medical writers and managers 

of medical writers.1 The Competency Model establishes  

5 core competency domains through which the KSABs appli-

cable to medical writing can be assessed and a medical writer’s 

competency can thus be certified.1,3 These 5 core competency 

domains are gathering, evaluating, organizing, interpreting, 

and presenting.3 They are the backbone of medical writing cer-

tification and the foundation of the Medical Writer Certified 

(MWC) examination.1,4 In addition to defining and facilitating 

assessment of the core competencies that contribute to a med-

ical writer’s value, the Medical Writing Competency Model and 

MWC examination inherently provide guidance on training to 

help medical writers achieve their full potential.

OBSTACLES TO EFFICIENCY
Notwithstanding the training and competency models cur-

rently available, there are still substantial obstacles and 

barriers to efficient medical writing to be recognized, acknowl-

edged, and overcome. These obstacles have a significant and 

direct impact on submission timelines, success, and ultimately 

the speed of delivery of new medicines to patients.

Lack of Adequate Writing Skills and Strategy
Documents prepared without using lean writing techniques 

take longer to write, review, approve, and therefore submit. 

They also slow down the regulatory review and approval by 

agencies. Thus, not only the sponsors but also, ultimately, the 

end users of new drug treatments are affected by these docu-

ments that hinder readability and comprehension.5 Oshiro et 

al surveyed registrants of 12 noncompulsory workshops on sci-

entific publishing, in which respondents were asked what they 

found most difficult about preparing a manuscript.6 Two of 

the most common barriers to manuscript publishing included 

uncertainty about how to organize. Lean writing techniques 

and technical skill in writing help give a writer clarity in struc-

turing thought and organizing it into a meaningful order with 

a good thought flow. When a document is structured to present 

data in a manner that builds ideas, the reader can more easily 

follow what the intended messages are and can more readily 

understand the conclusions.

Insufficient Time
A key barrier to efficient medical writing is having sufficient 

time to craft the documents. Writing is an iterative process and 

writing the scientific documents that medical writers prepare 

is also a collaborative process involving multiple stakehold-

ers, all of whom bring different perspectives that are relevant 

to the totality of the storyline. This means that timelines for the 

writing activities need to allow for sufficient time to pull a large 

amount of information together from multiple sources and 

weave it into a cohesive document. Timelines need to permit 

teams the bandwidth to strategically review the ideas and data 

presented. Complex documents with many interrelated topics 

may require multiple reads, with adequate timelines support-

ing this activity.

 In addition, the time available for medical writers to focus 

on the data presentations and honing of the messaging is 

often reduced because they are not given the right tools and 

processes to optimize their writing time. For example, in the 

absence of good templates, medical writers need to spend time 

on predefining headings, styles, and formats, which means that 

less time is available to spend on the scientific content.7 They 

might be given PDF files as source documents, which means 

they must spend time reformatting content taken from these 

files; or the team might insist on not using a lean approach to 

presenting the data, and the medical writers are asked to pro-

duce long, unwieldy documents full of bulk. Because timelines 

are rarely extended to accommodate these extra activities, 

adequate checks for scientific rigor are foregone, errors may 

be overlooked, and the relevance of interrelated data points 

may not be captured.8 As writers face ever-accelerated loom-

ing deadlines, they are working longer hours, resulting in 

increased errors and an overall loss of quality. A study on qual-

ity metrics for clinical study reports found that for medical 

writers whose work rate exceeded the standard work rate by  

1.5 times, it was more likely that major sections of the draft 

clinical study report required reworking than for medical  

writers whose work rate did not exceed the standard.9

Insufficient Training
Good and continued training is crucial to ensuring that these 

regulatory documents are being written by medical writ-

ers who have the lean writing skills to present the data with a 

structure that improves readability and guarantees they are 

fit for purpose. Training is needed not only on communica-

tion of clinical messages but also in interpretation of the data 

in the first place. Sharma highlighted that the key barrier that 

medical writers from India face in producing quality regula-

tory documentation is training because of a lack of a stan-

dardized training curriculum.10 Lack of training can result in 

flaws in connecting the results to the conclusions, leading 

to claims that are not adequately supported or are errone-

ously reported.8 Diong et al conducted an analysis on research 



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

papers and found poor statistical reporting, including implied 

or gross spin, use of standard errors or the mean to calculate 

data variability, and lack of P value reporting for primary analy-

ses.11 This demonstrates a clear lack of understanding on how 

to be reporting this information, which could be avoided if 

medical writers had adequate training in this area.

Barriers to Document Quality
Given that regulatory documentation is critical for drug 

approval, these documents need to be of a high quality and 

accurately reflect the data supporting the proposed indica-

tion. Review of regulatory documents by subject matter experts 

during the authoring process ensures that the data have been 

correctly interpreted and that key messages are supported; 

however, getting reviewers to provide the necessary input can 

be challenging. As a result of competing priorities, they often do 

not have sufficient time for their review, which results in inad-

equate checks of methods, results, or conclusions and can con-

tribute to the introduction or oversight of errors.8

 Inconsistencies, both between documents in a submission 

dossier and between documents and their source data, hinder 

review by regulatory agencies, resulting in unnecessary ques-

tions and responses. Li et al provided an example of the review 

of an IND submission in which a discrepancy in a definition of 

a key term, which on the face of it may seem relatively minor, 

confused a regulatory reviewer who questioned the sponsor in 

the regulatory response.12 This error, which would have been 

simple to correct during document review or quality control, 

led to wasted time and effort on the sponsor’s part and was a 

fully avoidable delay to approval.

OPTIMIZING EFFICIENCY: IMPACTS OF 
LEADERSHIP AND TRAINING STRATEGY ON 
MEDICAL WRITING VALUE
Maximizing medical writing value requires investment in train-

ing and thoughtful leadership. How a medical writing depart-

ment utilizes its writers may impact the value potential of the 

team. Managers who encourage specialization in a specific 

document type or phase of development (ie, the creation of 

functional silos) are working toward short-term efficiencies 

only. Functional silos can result in inefficiency and employee 

dissatisfaction.13 Avoiding those silos is critical for establish-

ing an environment of flexible and creative problem-solving, 

and writer overspecialization can lead to reduced knowledge, 

collaboration, creativity, and confidence.14 This does not mean 

that medical writers should never work on the same docu-

ment twice in a row. Indeed, a writer needs to write any one 

document type several times to become truly confident in the 

unique features of that document and understand its needs. 

But by allowing writers to work on multiple document types, 

in different therapeutic areas, they gain a broader understand-

ing of how the documents relate to each other and how they 

need modifications for different settings. This broader oversight 

makes them better able to advise teams and construct docu-

ments that are more fit for purpose. Building an agile, broadly 

experienced team also positively impacts employee satisfaction 

and career development as it gives the writers more options to 

work in areas that better fit to their personal character (some 

writers enjoy writing about pharmacokinetics and others prefer 

safety topics), which keeps them engaged and gives them 

growth potential.

 Effective leadership thus requires investment in cross-

training and broader development of writing staff; in other 

words, it requires seeking to create medical writing “generalists” 

rather than “specialists.” The value of generalists over special-

ists is known from other industries, and David Epstein, author 

of Range: Why Generalists Triumph in a Specialized World,15 

describes the benefit of more generalized training like this:  

“The more varied your training is, the better able you’ll be to 

apply your skills flexibly to situations you haven’t seen.”16  

This book describes many examples of the impact of broader 

education on the ability to solve problems creatively. The gen-

eralist trainee is not constrained to understanding the same 

repetitive pattern of working.15 Likewise, a writer who has 

written for all phases of development and across a variety of 

regulatory and clinical document types will have a breadth of 

experience that lends itself to valuable and creative contribu-

tions to document strategy.

 Beyond training at the document level, building a strong 

writing team requires leadership that combines informed hiring 

decisions with day-to-day demonstration of desired behaviors. 

When regulatory writers were surveyed, the skills they were 

most recognized for on their teams were leadership and collab-

oration skills (see The Regulatory Writer's Perspective on page 

152), indicating that these soft skills are a critical dimension 

of the regulatory writer’s role. The survey also revealed leader-

ship skills, collaboration skills, and project management as the 

top areas in which writers desire more training. Managers need 

to hire staff with the curiosity and team spirit needed to form 

a solid working group. The managers themselves then need to 

lead by example of the desired traits that solidifies a team. This 

includes showing a willingness to ask the right questions and to 

collect varying viewpoints on a problem (Table 1 on next page). It 

also includes encouraging horizontal relationship-building with 

other functional areas so that the medical writing team has a 

shared vision and understanding of goals with those other func-

tions.17 Teammates who learn to collaborate across functional 

boundaries gain skills faster and increase business efficiencies.18

 Multiple studies describe a link between employee sat-

isfaction and effective training.19 A study of human resource 



AMWA Journal / V36 N4 / 2021 / amwa.org    141

employees showed a statistically significant impact of train-

ing and development on employee satisfaction and con-

cluded with a recommendation to provide training oriented 

not only to work tasks but also to the developmental goals 

of the employee (eg, more generalized training opportuni-

ties).20 Not only do generalist skills aid writers’ development, 

but these skills can also help them to progress in their career. 

The progression from individual contributors to managers 

to enterprise-level leaders requires multiple “seismic shifts” 

in thinking, including a willingness to train as a generalist as 

opposed to a specialist.21 Supporting this idea, a survey con-

ducted in 2013 revealed that 60% of respondents felt their 

manager was a “good generalist” with broad transferable 

skills in people management and leadership, which are  

necessary for more senior positions in an organization.22 

Broad training strategies, then, need a company’s atten-

tion for both improving problem-solving as well as positively 

impacting employee satisfaction and development into more 

senior roles, all of which elevate the value of the medical  

writing organization.

Table 1. How to Ask Good Questions

Common Pitfalls Effective Inquiry

Start With Yes-or-No 
Questions.

Start with open-ended questions 
that minimize preconceptions. 
(“How are things going on your 
end?”; “What does your group 
see as the key opportunity in this 
space?”)

Continue Asking Overly 
General Questions 
(“What’s on Your Mind?”) 
That May Invite Long 
Off-Point Responses.

As collaborations develop, ask 
questions that focus on specific 
issues but allow people plenty of 
room to elaborate. (“What do you 
know about x?”; “Can you explain 
how that works?”)

Assume That You’ve 
Grasped What Speakers 
Intended.

Check your understanding by 
summarizing what you’re hearing 
and asking explicitly for correc-
tions or missing elements. (“Does 
that sound right—am I missing 
anything?”; “Can you help me fill 
in the gaps?”)

Assume the 
Collaboration Process 
Will Take Care of Itself.

Periodically take time to inquire 
into others’ experiences of the 
process or relationship. (“How do 
you think the project is going?”; 
“What could we do to work 
together more effectively?”)

Adapted from Edmonson et al.18

SOFT SKILLS THAT INCREASE EFFICIENCY  
AND ADD VALUE
Soft skills, in addition to technical knowledge, are essential for 

medical writing success.1,2 These skills are increasingly rec-

ognized as an important contributor to competent job per-

formance in a wide range of fields.1,2,23-36 A recent survey was 

conducted with human resources and learning development 

specialists, including C-level executives, senior managers, 

and managers/supervisors, at companies ranging in size from 

<1,000 to >50,000 employees in a variety of industries, includ-

ing technology, manufacturing financial services, health care, 

retail, hospitality, telecommunications, and education.36 The 

survey found that across industries, the need for soft skills is 

nearly as difficult to fill as the need for hard skills.36 The most 

in-demand soft skills identified by survey participants were 

critical thinking, communication, and creativity.36

 However, as the need for soft skills grows, they are only 

briefly mentioned within the context of medical writing.1 The 

Medical Writing Competency Model includes a list of soft skills 

in a supplementary table of general abilities that are appli-

cable to all medical writers, regardless of their area of spe-

cialty.37 These soft skills include assertiveness, compromise, 

decisiveness, kindness, conflict resolution, flexibility, leader-

ship, resilience, negotiation, and openness.37 Many of the soft 

skills listed in the Competency Model are mentioned in other 

articles on medical writers and medical writing.1,2,23-35 Many of 

these authors identify additional soft skills they believe are also 

crucial for medical writer and manager competency (Table 2).

Table 2. Important Soft Skill-Based Competencies Not Listed 
in the Medical Writing Competency Model1

Soft Skill Cited in:

Project Management Pal 2019,24 Limaye 2020,25  
Saleh 2020,27 Guillemard 201428

Time Management Heisel-Stoehr and Schindler 2012,23 
Flaherty 2014,26 Nice 201630

Multitasking Heisel-Stoehr and Schindler 2012,23 
Pal 2019,24 Nice 201630

Critical Thinking Flaherty 2014,26 Guillemard 201428

Cultural Competency Heisel-Stoehr and Schindler 2012,23 
Flaherty 201426

Ability to Work 
Independently

Heisel-Stoehr and Schindler 2012,23 
Pal 201924

Work Ethic Heisel-Stoehr and Schindler 2012,23 
Flaherty 201426

Attention to Detail Heisel-Stoehr and Schindler 2012,23 
Nice 201630

Networking Heisel-Stoehr and Schindler 201223

Self-Motivation Pal 201924



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

 Many of these soft skills are relevant to the competency, 

and ultimately to the value, of all medical writers. An analysis 

of regulatory medical writing job opportunities posted on the 

European Medical Writers Association website between 2009 

and 2011 ranked the behavioral and social soft skills required 

of medical writers by the frequency of their appearance in job 

posting advertisements (Table 3).

 Medical writers are recognized by drug development stake-

holders, including study sponsors and government agencies, 

as valuable contributors to drug research and regulatory pro-

cesses.32 Part of that value lies in their technical understanding 

of how to craft thought and their regulatory understanding of 

the needs of the various documents. Yet their soft-skill com-

petency is an equally important aspect of their value for their 

ability to pull teams together and keep stakeholders focused 

on messaging, timelines, and collaborative work ethics. Their 

ability to manage projects brings an essential value to their 

role. As noted by Ohms, a good project manager shepherds 

their projects and understands the interplay of the different 

functional areas involved.38 Ohms points out that the 4 features 

of an exceptional project manager are (1) respecting others 

earnestly, (2) knowing when to speak and let others speak, (3) 

understanding the details driving the project, and (4) taking 

the time to self-assess and maintain focus. All of these fea-

tures typify the skills that a good medical writer needs to have 

to successfully complete their projects on time and with a well 

written document.

FEEDBACK FROM REGULATORY AGENCIES ON 
THE VALUE OF MEDICAL WRITERS
The AMWA working group’s survey designed for regulators 

who review documentation prepared by medical writers gave 

some valuable insights into how the agencies perceive the 

role of medical writers and the value they bring to regula-

tory documents (see The Regulator’s Perspective on page 145). 

Regulators recognized and acknowledged the value that medi-

cal writers add to the regulatory documents they work on. They 

believe that medical writers improve document quality, which, 

unsurprisingly, is extremely important for regulatory reviewers. 

They confirmed that poor document quality can hamper the 

ability of the reviewer to provide an assessment, which in turn 

delays the drug approval process and in some cases can even 

sensitize reviewers to subsequent submission documents from 

the same sponsor.

 These survey results provide meaningful data to support 

how we present ourselves within our organizations and how 

we should develop our medical writers—quality is clearly 

highly valued by regulators, and the regulators’ feedback illus-

trates the need for a sufficient supply of highly trained writers. 

Ultimately, the regulatory reviewers made it clear that they are 

looking for lean but fully developed documents that make the 

scientific rationale clear and show how it is supported by the 

data. When training medical writers, we must equip them to 

lead teams to create documents that are concise and clearly 

present the message. There is also a clear need to focus on 

team management and soft skills that enable writers to lead 

and guide the authoring teams.

 We can conclude that many regulatory reviewers under-

stand the role of medical writers and believe that they make 

the job of the reviewer easier. Medical writers are clearly valued 

and respected by regulatory agencies, and these take-home 

messages should empower the medical writing profession and 

help to shape the ongoing training of medical writers.

OPTIMIZING THE ROLE OF THE MEDICAL 
WRITER
To optimize the role a medical writer plays on cross-functional 

teams, we need to understand the skill set that these writers 

require to play this role well. Ultimately, a good medical writer 

must master 3 main areas: writing skills, understanding the 

regulatory needs of the documents they are writing, and inter-

personal skills to effectively manage projects.

 Writers need to have excellent writing skills to effectively 

communicate the thoughts and vision of the document from 

their teams. This involves not only knowing how to structure 

thought in well-formed sentences but also how to structure the 

document in such a way that a reader comprehends how the 

various data points build on each other to form the intended 

messages. Developing a good medical writer, therefore, must 

begin by having someone who already has a talent and passion 

for writing and then must progress to guiding them to hone 

Table 3. Top-Ranked Soft Skills in EMWA Job Ads for  
Regulatory Medical Writers: 2009-201123

Behavioral Skills
Percentage  

of Ads Social Skills
Percentage  

of Ads

Leadership, 
Team Working

62 Communication 47

Networking 56 Interpersonal 22

Organized 33 Work 
Independently

18

Time 
Management

30

Detail-Oriented 27

Multitasking 15

Conflict 
Management

10

Ads, advertisements; EMWA, European Medical Writers Association.



AMWA Journal / V36 N4 / 2021 / amwa.org    143

their craft. Like any talent, writing skills get better with train-

ing. Teaching a writer to write better requires having someone 

who already has the skills to take the time to review and revise 

the text of the learning writer to show them how to improve. 

This is an investment of more than just giving them a well-

written document and asking them to emulate it. It needs a 

trainer who will pull apart what the writer wrote, reconstruct it, 

and then take the time to explain why and how. People learn by 

making mistakes, and it is only when we are shown those mis-

takes and understand how to avoid them that the learning pro-

cess takes place.

 Writers also need to understand the unique purpose of 

each type of regulatory document. Many of these documents 

contain similar information, but the intention of each docu-

ment differs. Some are meant to communicate to investiga-

tors, others are meant to communicate to regulatory reviewers, 

and all of them need to tell a slightly different part of the 

story for different purposes. Medical writers not only need 

to learn the theory of the regulatory requirements specified 

by the International Council for Harmonisation of Technical 

Requirements for Pharmaceuticals for Human Use and other 

agency guidelines that define what each document is meant to 

do but also need to be given sufficient guided practical training 

to see how teams build, discuss, and craft these documents. 

This includes having the opportunity to see feedback from 

agency reviewers on different types of documents and be part of 

teams who revise the documents in response to this feedback. 

Think of the difference between learning to fly a plane by read-

ing the instruction manual and spending 10,000 hours in the air 

with a coach. Only the latter produces a seasoned pilot. This is 

an instance in which the concept of a generalist compared with 

a specialist becomes salient. Ensuring that a writer has practical 

experience on a broad spectrum of documents across a clini-

cal development program gives them more depth of knowledge 

and makes them more versatile overall. It means they can truly 

advise teams on what fit for purpose looks like for different doc-

ument types and that they help teams achieve that.

 Finally, to optimize the value of a medical writer, we need 

to ensure that writers can train on the soft skills identified pre-

viously. This requires creating a safe environment that empow-

ers them to challenge their boundaries as they learn how to 

assert themselves and corral teams. This training should come 

initially through demonstration, as novice writers witness 

experienced writers steering their teams and collaboratively 

working alongside other functional areas to develop docu-

ments. As writers develop, they must be granted increasing 

responsibility for running simpler meetings with an experi-

enced writer there to support them, if needed. The acquisi-

tion of soft skills can be the most challenging dimension of 

writer development. Many writers are not extroverts by nature, 

and gaining the confidence to speak up and challenge sub-

ject matter experts often means overcoming their natural ten-

dency to sit back and let others lead. By creating a situation in 

which writers first learn by example, writers are then allowed 

to execute within a safe environment and finally function inde-

pendently once they have the necessary skills. We must give 

them the encouragement and security to grow without fear 

of embarrassment or risk of failure. In this way, we nurture 

strong, confident writers who have the wherewithal to  

collaborate with even the most demanding teams. Through  

training and development with a focus on both technical and 

soft skills and identification of growth opportunities for new 

and developing writers, we can continue to address the chal-

lenges discussed here and foster the next generation of regula-

tory writers.

Author declaration and disclosures: The authors note no commercial 
associations that may pose a conflict of interest in relation to this article.

Author contact: dylan.harris@takeda.com

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General Principles of 
Word Usage

www.amwa.org/online_learning
Choose the right word for accuracy and clarity.

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https://www.forbes.com/sites/brentgleeson/2013/10/02/the-silo-mentality-how-to-break-down-the-barriers/
https://www.forbes.com/sites/brentgleeson/2013/10/02/the-silo-mentality-how-to-break-down-the-barriers/
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