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

AMWAJournal.org     11

ABSTRACT 
Medical writers play a key role in global regulatory submis-

sions across the pharmaceutical industry. Before the  

COVID pandemic, many companies were working toward 

development of global regulatory submissions, with their 

medical writers playing a key role in this process. During  

the pandemic, the need for greater collaboration in fully 

remote working conditions, inclusion and transparency, 

and the unprecedented demand for speed and quality of 

clinical development has brought global ways of working 

into even greater focus. A panel of medical writers, includ-

ing department and regional heads and subject matter 

experts, were invited to consider how other influences on 

our industry may drive the evolution of medical writing yet 

further as a global profession in the coming years. This  

article summarizes the panel’s responses to 5 questions  

on the future direction of the profession.

Medical writing is an increasingly global profession. During 

the past few years, the effects of the COVID pandemic have 

only served to increase the ways in which it is possible to 

be a medical writer on global teams regardless of one’s own 

location. We invited a panel of medical writers to gaze into 

their crystal balls and consider how medical writing may 

yet further evolve as a global profession over the next 10, 20, 

or more years. Participants were invited to consider 5 ques-

tions on the future direction of the profession and to pro-

vide short responses to as many of the questions as they felt 

able. Our panel included department and regional heads 

and subject matter experts (SMEs); their biosummaries can 

be found at the end of this article.

How has the impact of the pandemic and increasing 
demands on the speed, quality, and complexity of clin-
ical development driven globalization? What solutions 
initiated from medical writing have been successful to 
accommodate this change? Where might this lead  
us next?

Jonathan Mackinnon: The pandemic and increasing com-

plexity of clinical development is driving a need for more 

expansive multinational or multiregional clinical trials 

that cover a greater geography in order to access increas-

ingly specific participant populations. In response, medi-

cal writing associations are increasing education/training 

efforts in how to manage these changes as part of regula-

tory document preparation. Over time, this might lead us 

to increased specialization within the medical writer com-

munity where—once a writer has an established a base skill 

set via experience across regulatory documents—they start 

to specialize in certain areas so that they can stay up to date 

with the current challenges, eg, data analysis and reporting 

versus study design and setup.

Linda Yih: In terms of impact, more compounds seem to 

be moving ahead “at risk,” so teams need to take this into 

account when it comes to planning and contingencies. 

Successful writers have been able to drive effective  

Julia Cooper,1 Jeannene Butler,2 Kelley Hill,3 Garima Pallavi,4 Grishma Kanchan,4 Jonathan Mackinnon,5 Renee Primus,6 
Matthew Renda,3 Linda Yih,7 and Nan Wang8 / 1Parexel International (IRL) Limited, Dublin, Ireland; 2Otsuka Pharmaceutical 
Development & Commercialization, Princeton, NJ; 3Alexion, AstraZeneca Rare Disease, Boston, MA; 4Parexel International 
India Development & Commercialization Safety Services Private Limited, Bangalore, India; 5Parexel International S.L., Madrid, 
Spain; 6Bristol Myers Squibb, Princeton, NJ; 7Parexel International LLC; 8Bayer Healthcare Co. Ltd., Beijing, China

Globalization  
and the Future  
of Medical Writing 

THEME ARTICLE

http://www.amwajournal.org


AMWAJournal.org     12Globalization and the Future of Medical Writing 

collaboration and communications, mediate differences, 

and validate actions to meet overall goals. Cultural aware-

ness (whether country, company, or team-specific) has 

become key to encourage open discussion and ensure all 

parties are heard and understood. Future collaborations 

may require refined skills in managing conflict, negotia-

tion, influence, and persuasion.

Renee Primus: During and postpandemic, we have wit-

nessed the importance of rapid mobilization to meet new 

and unexpected global requirements ensuring patient 

safety and access to treatments. The consequences of 

global disruption have pointed to the need for greater col-

laboration, inclusion, and transparency and a call to action 

for a shared objective among all members of the health 

care system. Members of the medical writing profession 

have been and continue to be well-positioned as problem 

solvers during disruption by bringing innovative solutions 

and leading complex deliverables. For example, COVID-

related country-level commitments and the development 

of processes, tracking, reporting templates, and oversight 

to meet compliance and quality were key leadership con-

tributions from medical writers—and during a time of 

urgency and under some extreme conditions. In addition, 

structural, content, and harmonized updates to existing 

regulatory documentation (eg, Periodic Aggregate Safety 

Report and the Clinical Study Report) provide another 

example of leadership from medical writing to drive 

well-communicated, transparent, and consistent report-

ing for global digestion. The call to action includes greater 

data-sharing using secured technologies and harmonized 

ways of working including more integrated and collabora-

tive health authority (HA) shared accountabilities. 

Nan Wang: COVID has had a negative impact on a global 

basis in certain industries, but other professions that can 

be relatively easily adapted into remote forms will expe-

rience heightened demand, such as medical writing. The 

unprecedented demand for the speed and quality of clini-

cal development has driven us to pursue even higher levels 

of globalization. Ever-increasing global standardization 

and automation should be the key drivers for a successful 

medical writing organization.

Jeannene Butler: One “silver lining” for the pandemic was 

that it necessitated organizations to think differently about 

the conduct of their clinical trials, and we saw innovative 

solutions designed to keep clinical development programs 

moving forward, despite the limitations to person-to- 

person contact. In medical writing, there was also no pause 

in our work, and globalization of our regulatory submission 

documents continued to be a focus for our team. We often 

preplan for global submissions by starting our documents 

much earlier, even before the completion of the final clini-

cal trial, with region-specific background text and assumed 

successful outcomes. Adding in more automation and 

technology to this early-writing process can help to reduce 

the time and effort for the medical writers and may also 

reduce the impact for rework by the medical writers in the 

later stages of document development.

Kelley Hill & Matthew Renda: Medical writers have always 

been able to work remotely. During the pandemic, they 

exemplified efficient and effective communication, high 

productivity, and high quality, helping the world adjust 

to remote work. Increased demands leading to increased 

collaboration across time zones have necessitated the use 

of shared document platforms and highlighted the impor-

tance of careful document handoffs to “follow the sun.” 

However, the expectation that one is always available 

increased propensity for “burnout,” which many expe-

rienced as time went on. Multitasking was taken to an 

extreme in some cases, which may have led to a decreased 

ability to focus and affected critical thinking. It will be 

increasingly important to leverage technology and pro-

spective planning wherever possible and have priority 

established by management to keep focus and quality from 

all contributors at its peak.

Julia Cooper: Medical writing lends itself to remote work-

ing, and this has been a common model in North America 

and parts of Europe for many years. During the pandemic, 

virtual teams were a necessity (and still are) but also 

brought benefits such as being able to hire diverse talent 

in geographical locations where office-based working was 

previously the norm. Employee satisfaction has increased 

through flexible working hours, autonomy, and the ability 

to work from different locations. Zoom, Microsoft Teams, 

and similar platforms help maintain employee engage-

ment; however, building team cohesion can still be a  

challenge. In the future, we need the technology to evolve 

yet further (think Star Trek holodeck!) to provide an  

environment as close as possible to a face-to-face meeting 

when opportunities for in-person meetings are limited or  

nonexistent.

Grishma Kanchan: With increased demands on the  

speed, quality, and complexity of clinical development, 

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AMWAJournal.org     13Globalization and the Future of Medical Writing 

globalization via social integration has been one of the big-

gest outcomes of the pandemic. Medical writing has pre-

dominantly been a geographically diverse team; however, 

the pandemic pushed us to focus on sustainable and inclu-

sive growth, which required changing our work culture to 

maximize contributions of people globally. Medical writing 

was quick to implement platforms for global collaborative 

work. With technologies continuing to improve, we must be 

open to new ways of working, such as collaboration in the 

Metaverse. The Metaverse could aid meaningful interac-

tions between colleagues by replicating an office environ-

ment. Communication in the Metaverse may also be more 

authentic and build trust when compared with face-to-face 

conversations which may, at times, be affected by social 

anxiety or lack of confidence. Coming together in  

the Metaverse can be empowering by creating a space 

where people at work can feel present, connected, and  

productive. The Metaverse could also give medical writers 

the chance to observe, learn from, and work alongside the 

best in the industry, without physical or geographical barri-

ers. In clinical development, medical writers could immerse 

themselves in real-life scenarios and gain insights into a 

patient’s or physician’s journey to devise solutions for exist-

ing challenges. The Metaverse may also allow medical writ-

ers to understand the “larger picture” by helping to visualize 

the clinical development process from drug discovery and 

development to approval and postmarketing surveillance. 

This could provide writers with key knowledge to under-

stand the target audience and write better and effective  

clinical documents.

How might the medical writing profession be defined 
in the future, eg, common certification or development 
programs, shared job descriptions, intergalactic medical 
writers association, sharing ideas across companies, dif-
ferent relationships between clinical research organiza-
tions (CROs)/contractors and sponsors, other?

Linda Yih: We can make great strides together by sharing 

ideas and solutions to common challenges across compa-

nies. AMWA is already spearheading this effort with indus-

try leads on several important topics. On a more granular 

level, this can be achieved by building mutually trusting 

relationships between CROs/contractors and sponsors. All 

involved need to be transparent with their needs and con-

cerns and open to others’ perspectives. 

Jeannene Butler: Regulatory medical writing is quite  

different from other types of medical writing and would 

benefit from having its own global standards and develop-

ment programs. A global regulatory medical writing organi-

zation would allow for a more focused view of our specific 

writing profession but expanded to include perspectives 

and ideas from across the world. An increased focus on edu-

cation for newer medical writers at the undergraduate level 

is needed. This could be in the form of 1 or 2 courses for 

regulatory medical writing to be added to the curricula for 

related health science degrees or expanded to develop an 

overall medical writing major program at colleges and uni-

versities, where common elements of scientific writing are 

taught, and the regulatory medical writing courses could be 

a concentration for that major.

Renee Primus: The regulatory writing profession requires 

recognition as a defined role in driving speed to patient. A 

common pain point by writers is that they are not always 

used for their skills in strategic writing and leadership but 

instead misunderstood as formatters and scribes. The writer 

brings value as an expert on regulatory requirements  

supporting regulatory review and approval and accordingly 

shapes documents to strategically address these require-

ments. Sponsorship across pharmaceutical companies and 

CROs to form well-defined, harmonized, and consistent 

position profiles capturing core capabilities and responsi-

bilities would promote the profession and effectively pave 

the way to a degree-facing curriculum integrated with  

regulatory affairs. A curriculum design recognizing the 

multiple and overlapping responsibilities between regula-

tory writers and regulatory strategists would meet the needs 

of future changes to the regulatory landscape promoting 

speed to patient.

Nan Wang: Medical writing has a long history in Europe and 

North America and is well defined and recognized in the 

pharmaceutical industry. 

• In the future, the medical writer’s role and responsi-

bility will be better recognized and accepted in other 

developing regions, eg, Asia-Pacific. The trend has 

already been observed in China. 

• An industry community facilitating knowledge and 

experience sharing across companies and the under-

standing between CROs, sponsors and investigators 

will play a more important role.

Kelley Hill & Matthew Renda: Assuming that “medical 

writing” in this instance refers to regulatory writing, build-

ing a framework for developing writers within secondary 

education/universities would provide a pipeline of future 

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AMWAJournal.org     14Globalization and the Future of Medical Writing 

writers. This would include a broad framework that begins 

with superb writing skills as well as expanded skill sets 

required for data interpretation and detailed knowledge 

of regulatory governance. To further career development, 

management training would include strategic planning, 

project management, resource planning, technology skills, 

contract negotiation, and the ability to coach for career 

development. The business of medical writing also requires 

the need to assess what skill sets are needed for specific 

projects. In addition, the expanding requirements for trans-

parency and plain language writing offer separate but 

related paths for development. Core competencies could 

be identified and job levels that are aligned across compa-

nies would also help define specific job titles, making them 

more uniform across the industry. This would help control 

“title inflation,” which is often the reason writers will leave 

one company to move to another, which erodes institu-

tional knowledge and experience, the bedrock that medical 

writers contribute to drug/device development.

Garima Pallavi: Clinical trials are becoming increasingly  

complex; adoption of advanced technology is slowly 

becoming the norm. The pharma industry is moving toward 

personalized medicine/precision medicine. This shift-

ing landscape requires medical writers to be adequately 

equipped to develop expertise in these areas, understand 

and expertly design studies, and communicate results to 

regulators. Complex study designs call for medical writ-

ers to develop the right amount of subject matter exper-

tise. The rapidly changing regulatory terrain also requires 

medical writers to continually learn and develop their core 

competencies. The COVID pandemic has underscored that 

the magnitude of globalization in the health care indus-

try is going to see a steep rise. Companies that already 

had medical writing operations spread out globally expe-

rienced minimal disruption in their business. To keep up 

with the rapidly evolving demand in the industry, compa-

nies must focus on building a globally diverse talent pool. 

Global capability centers (GCC) are swiftly becoming the 

new normal, and companies are giving up their traditional 

beliefs about having a concentrated talent pool to adapt to 

a GCC model. The advantages of a global talent pool are 

multifold: from ensuring round-the-clock business conti-

nuity to leveraging on a world-class talent pool and build-

ing resilient and agile capabilities. Building and nurturing a 

global talent pool will require using shared job descriptions, 

employing standard hiring methodologies, a common 

approach to training, upskilling of staff, and applying uni-

form performance and conduct standards. Professional 

medical writing associations offering certification programs 

such as AMWA and EMWA provide vast opportunities for 

writers to learn and expand their network; however, these 

associations have mostly had a strong regional presence. 

To meet the fast-paced demands of the industry, it will be 

imperative to shift the mindset to have a global community 

of medical writers, which allows the whole fellowship to 

develop common skills. COVID has taught us that we can 

successfully organize virtual conferences and training pro-

grams and make SMEs more accessible to colleagues glob-

ally. The future of medical writing will be about breaking 

down silos and unlocking a diverse talent pool that tran-

scends geographical boundaries. 

Jonathan Mackinnon: As complexity increases, it’s likely 

that certification or training programs will become more 

commonplace to demonstrate a base skill set. Within reg-

ulatory medical writing, my view is that study design and 

transparency will be significant drivers of lasting change. 

• Study design: complexity and simplicity are at oppos-

ing ends of the pendulum but are increasingly being 

woven together as more specific interventions (more 

targeted action and more complex endpoints) are 

being included in studies looking to simplify participa-

tion and minimize burden. Medical writers will need 

to be able to navigate the increased design and analysis 

complexity as well as participate in risk assessments, 

derisking (eg, applying passive data collection from 

digital health technologies to replace on-site clinical 

assessments), and subsequently simplification. 

• Transparency: regulatory documents used to be 

considered highly prized proprietary information 

with restricted access, whereas now, publicly avail-

able redacted regulatory documents substantially 

increase medical writer access to precedent content. 

Consequently, how medical writers engage with prec-

edent and standardized content and how that con-

tent facilitates downstream process will form part of a 

medical writer’s training.

What kind of regulatory changes might impact the way 
medical writers work in future? Do you anticipate recent 
or future regulations (what kind?), or changes at the reg-
ulators themselves, driving change for medical writers? 
What could that look like?

Jonathan Mackinnon: Maturation of the understand-

ing of risk and risk mitigation (International Council 

for Harmonisation of Technical Requirements for 

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AMWAJournal.org     15Globalization and the Future of Medical Writing 

Pharmaceuticals for Human Use (ICH) E6[R2]) as well as 

a fundamental shift toward Quality by Design (ICH E8[R1] 

and the likely reflection of this in ICH E6[R3]) will have a 

material impact on medical writer work in the future. More 

sophisticated risk management strategies, targeted enroll-

ment and forecasting, and quality-focused study design 

will change the way studies are designed and analyzed. 

Designing study protocols will combine a greater under-

standing of risk management and mitigation verbiage with 

new methodology for constructing studies that focus on 

critical to quality factors; for clinical study reports, reporting 

on these strategies will become more commonplace.

Kelley Hill & Matthew Renda: Increased transparency 

requirements (ie, European Union Clinical Trials Regulation 

(EU CTR)) are already changing the way writers work, as 

personal protected data need to be identified early as part 

of an overall disclosure strategy and company confidential 

information adapted as more information becomes public 

during development. Specific examples: instead of “47 year 

old female from France,” data output is changed so the text 

reads “a 40 to 50 year old person from Western Europe.”

 One huge change would be if regulators move from the 

current document-centric Common Technical Document 

(CTD) structure to a real-time study data flow. Advanced 

computation in the coming decades might permit regulators 

to automatically interpret trial data with marketing applica-

tions built on a rolling basis. In such a future, medical writ-

ers would leverage technical and data science skills because 

documentation would be reduced to introductory/contextual 

statements, leaving interpretation up to the agencies. 

Renee Primus: The regulatory writer carries both technical 

and strategic expertise; current and future changes to the 

regulatory landscape, speeding access of new health care 

products to patients, will require this expertise more than 

ever and are already happening. Over the past 5 years, Food 

and Drug Administration (FDA) initiatives have been intro-

duced with impact to the regulatory writer. For example, 

Real-Time Oncology Review and the Assessment Aid aim 

to increase the speed of information for regulatory review 

and require both exquisite planning and focused reporting 

of complex and approval-supporting data—with quality. 

In addition, parallel review initiatives such as FDA Project 

Orbis require new approaches to work concurrently with 

multiple participating countries—with speed. Accumulus 

Synergy, creating innovative solutions to reduce regulatory 

review times and transform global data exchange, is another 

good indication of reshaping the industry by removing  

barriers to speed of information. In all these examples, the 

agile regulatory writer possesses the range of technical and 

behavior skills to both inform needed changes as well as 

execute in a changing global regulatory environment.

Nan Wang: Harmonization of regulations across the globe 

can be expected to enhance the global simultaneous devel-

opment and make drugs available to patients quickly.

• Medical writers in different countries/regions will 

work more closely and share knowledge and under-

standing, which will contribute to the establishment 

of the “global” document strategy and the process to 

support global simultaneous submission. 

• Medical writers working in specific countries/regions 

with unique regulatory requirements should take the 

initiative to understand a global approach and pro-

mote local requirements with solutions. They should 

take the bridging role to implement global-level  

standardizations.

Jeannene Butler: Based on recent learnings from EU 

CTR, we may need to consider revising the process and/or 

structure of how protocols and amendments are developed. 

Protocols require structure to clearly define parameters for 

the conduct of a clinical trial; however, because many trials 

are now being conducted globally, we need to consider how 

best to accommodate region-specific changes and requests 

from HAs in an expedited manner. For example, EU CTR 

Requests For Information (RFI) can come in from various 

member states, and these require responses, and often 

protocol amendments, within a couple of weeks. Instead 

of creating and maintaining country-specific protocol 

amendments for each change, perhaps the protocol could 

exist in an electronic format with version control and the 

ability to tag country-specific elements and switch the 

view depending on the region where the investigator is 

conducting the trial.

How might the skills profile and daily work for medical 
writers of the future be shaped by enhanced standardiza-
tion, harmonization, automation (artificial intelligence 
[AI]), or other factors?

Jeannene Butler: Although no AI would ever be able to 

completely replicate the skill and art of a human medical 

writer’s work, technology can, and should, be enhanced and 

socialized to make our jobs easier. If there was an increase 

in standardization and enhanced technology to assist with 

the daily work of medical writers, we would need to adapt 

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AMWAJournal.org     16Globalization and the Future of Medical Writing 

by becoming more tech-savvy ourselves, for example, learn-

ing the AI systems and coding to modify those as needed 

for our specific documents. What would NOT change would 

be the ability of medical writers to analyze scientific data 

and craft language around those results, and the critical soft 

skills of leadership, communication, and collaboration with 

our project teams and SMEs.

Renee Primus: Strategy and data design to support critical 

messages and drive labeling claims are key writer compe-

tencies but not leveraged enough due to some siloed ways 

of working across teams where preplanned data templates 

and lack of technology restrict manipulations. Technologies 

that allow direct interface and strategic data design for 

automated data entry while maintaining integrity would 

enhance more direct review and interpretation by regula-

tors. Writers working collaboratively to bring their insights 

will enhance team effectiveness in the production of fit-for-

purpose, message-driven documentation that aids the reg-

ulatory reviewer in their decision-making roles. In general, 

the more we remove the unnecessary and replace with  

strategic information design, the greater the value that writ-

ers bring to documentation will be realized.

Jonathan Mackinnon: It is likely that future medical 

writers’ skill sets will include elements of data science 

and content management as clinical research transitions 

from a document- to content-driven industry. Rather than 

developing a document in isolation, writers will be expected 

to work with interlinked content that is developed in 

parallel—as opposed to sequential document preparation.

Kelley Hill & Matthew Renda: Consideration of diversity 

and inclusion are missing from many types of document 

templates and should become part of the training for med-

ical writers. In addition, as industry moves to adopt auto-

mation and content-reuse to aid in document development, 

commensurate technical proficiency will be increasingly 

important for future medical writers. 

Nan Wang: Medical writers will need to be able to translate 

the dynamic regulatory environment and diverse regional 

regulatory requirements into standardized and harmo-

nized document strategy in order to foster communication 

efficiency. They will be able to work across boundaries and 

codevelop automation (AI) tools, which will add value to the 

medical writer’s daily work. With the powerful automation/

AI tools in place, medical writers will concentrate more on 

the generation of the content flow and process management 

to ensure adequate communication among cross-functional 

expert groups.

Julia Cooper: Technology applications for medical writing 

are evolving at a pace that would not have been anticipated 

a few years ago. It may be many decades before AI can fully 

replace a human medical writer; however, repetitive tasks 

may soon be accomplished by automation and/or AI, allow-

ing the writer to focus on the science. For example, patient 

narratives can already be programmed to a large extent. 

New AI-based tools may enable writers to generate tables 

and listings via an interface directly linked to the study or 

submission database, without requiring involvement of a 

programming team, or to identify trends and patterns in 

data for consideration when writing results sections. It will 

be important that we collaborate globally to understand the 

benefits and limitations of these new tools and what this 

means for the medical writer skill set going forward.

If budget and/or technology was no limit, how would you 
see global medical writing teams working/collaborating 
in the future?

Jeannene Butler: In an amazing future for medical writers, 

there would be standard document templates and language 

across companies and regions, endorsed by HAs worldwide, 

which would only need minor customization for each orga-

nization. With standardized templates, AI would then be 

developed to electronically create the data-driven sections 

of the documents once the trial(s) have completed database 

lock and data cleaning. AI would also create and manage all 

the technical elements of the documents, including tables 

of contents, abbreviation lists, reference lists, and all format-

ting elements. Background product/regulatory text would 

be created once by medical writers, reviewed by teams, and 

stored in a common “master” location that would then be 

automatically pulled into appropriate sections of the doc-

uments. If that text was changed in the master location, 

it would be automatically changed in every related docu-

ment, and there would be regional variations tagged as well. 

Medical writers would continue to work with the project 

SMEs to draft and refine summary and conclusion text for 

each document as their main focus.

Renee Primus: Modernization of ICH M4 guidance on 

the CTD – in particular on structure/content and leverag-

ing cloud-based templates and tools—would be one great 

opportunity for the field of medical writing to work together 

and drive innovation.

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AMWAJournal.org     17Globalization and the Future of Medical Writing 

Kelley Hill & Matthew Renda: Structured content use is 

already being adopted across the industry. Perhaps it would 

be possible to develop a shared platform of common text 

across all pharma/science for certain topics; for example, 

disease descriptions that are automatically updated with 

info from new publications.

Nan Wang: Medical writers will work with automation tools 

much more often. The human medical writer will focus on 

message and content, and the tool will focus on repetitive 

and routine tasks in the background. Medical writers from 

different countries/regions will work on global master 

documents, with knowledge and technical support, and 

contribute to the packages submitted in different regions. 

Medical writers will be involved much earlier in the process 

and will obtain better overview of the data flow in drug 

development.

Julia Cooper: In the future, medical writers will be able to 

focus on the science, for example, through intelligent access 

to content libraries for authoring protocols and semiauto-

mated generation of Clinical Study Reports and submission 

documents. The writer will truly be recognized as an expert 

in their own right, responsible for guiding the team through 

the limitations and advantages of an automated document 

generation process.

Jonathan Mackinnon: Ideally, deeper organizational col-

laboration on document standards, content standards, and 

content management processes.

Linda Yih: Medical writing teams would have a budget and 

time to train junior staff on live project work and allow them 

to shadow senior writers to learn the nuances of managing a 

team with confidence. Collaborative authoring tools would 

support training as well as urgent projects. As new technol-

ogies are introduced, writers will need to be agile in their 

learning while managers provide a safe environment for 

learning. The next generation of writers may also have ideas 

on how to use or create technology to work in more effi-

cient and meaningful ways. Knowledge-sharing and lessons 

learned sessions may be held to encourage transparency 

and continuous improvement. 

Grishma Kanchan: Metaverse! The Metaverse has the 

potential to break down physical and geographical barriers 

between people. Medical writing is a global team, and with 

the majority of writers working remotely and virtually, using 

the Metaverse to explore a collaborative world and to be 

able to connect and interact with one another is an exciting 

possibility.

LOOKING FORWARD
The future of medical writing will bring many opportuni-

ties to evolve as a global profession, learning to adopt new 

content-driven ways of working, expanding our skill set into 

data science, and capitalizing on new technologies that 

replace repetitive tasks. With a track record for agility, med-

ical writing is well-placed to adapt to this rapidly changing 

environment. Considering some recent developments that 

could not have been anticipated a few years ago, we need 

to remain vigilant to anticipate emerging global industry 

trends and what these may mean for expansion of our skill 

set. As a global profession, we also need to take ownership 

and drive these opportunities in a direction that increases 

the future value of medical writing yet further.

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

Author contact: julia.cooper@parexel.com 

BIOSUMMARIES
Jeannene Butler is Senior Director, Global Head of 

Medical Writing at Otsuka Pharmaceutical Development & 

Commercialization, and she leads a team of over 30 medical 

writers to develop clinical and regulatory documents for the 

worldwide Otsuka organization. Jeannene began her medi-

cal writing career in 2006 and has been a member of AMWA 

since 2007. She has contributed as a medical writing leader 

for several major pharmaceutical, CRO, and biotech  

companies.

Julia Cooper, PhD, is Corporate Vice President, Head of 

Global Medical Writing Services at Parexel International. 

She leads a team of around 270 clinical and regulatory 

writing staff across the Americas, Asia, Europe, and South 

Africa. Julia has been a member of AMWA and EMWA 

since 1995. From 2013 to 2016, Julia was based in Parexel’s 

Shanghai office, where she helped set up the China Medical 

Writers Community. She is an EMWA Nick Thompson 

Fellow and serves as chair of the AMWA Executives  

Advisory Council. 

Kelley Hill is Executive Director, Medical Writing and 

Clinical Trial Transparency at Alexion, AstraZeneca Rare 

Disease. She is a scientist and professional communicator, 

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AMWAJournal.org     18Globalization and the Future of Medical Writing 

with experience spanning over 30 years across the phar-

maceutical industry and academia. She has extensive clini-

cal regulatory and scientific writing experience in complex 

therapeutic areas, with a focus on rare diseases. She has 

served as a contributor to and in a leadership role for global 

clinical regulatory submissions supporting review and 

approval of drugs for diseases with unmet medical needs. 

She is an innovator with expertise in process improvement 

and operational excellence, and her global teams’ perfor-

mance has redefined benchmarks within Alexion for collab-

orative achievement and efficiency.

Grishma Kanchan is a Senior Medical Writer at Parexel 

International and has been with the organization for close 

to 7 years. She has a master’s in Biotechnology from the 

University of Salford, United Kingdom, and predominantly 

works in the rare diseases and disorders sector. 

Jonathan Mackinnon, PhD, is an Associate Director 

Medical Writing Services at Parexel International and a 

subject matter expert on clinical study protocols. He also 

teaches protocol development and trial design at the 

London School of Hygiene and Tropical Medicine.

Garima Pallavi is a Senior Director at Parexel International. 

She leads the medical writing department in India and pos-

sesses around 18 years of regulatory writing and leadership 

experience. 

Renee Primus, PhD, is Head of Global Scientific and 

Regulatory Documentation at Bristol Myers Squibb with 25 

years of experience in nonclinical research and clinical reg-

ulatory sciences. Renee and her team drive documentation 

strategy and authoring of message-driven, fit-for-purpose 

regulatory documents in support of drug development, sub-

missions, and approvals. 

Matthew Renda, PhD, is Director of Medical Writing 

Operations at Alexion, AstraZeneca Rare Disease. He has 

12 years of academic research experience focused on gene 

therapy and 15 years of pharmaceutical development expe-

rience providing regulatory submission management and 

medical writing leadership to optimize cross-functional 

processes, implement innovative technologies, and effi-

ciently develop clinical documents. 

Nan Wang, PhD, is Head of Medical Writing at Bayer 

Healthcare. She has more than 12 years’ experience in med-

ical writing from both pharmaceutical companies and a 

CRO. Nan is a founding member and chairperson of the 

China Medical Writers’ Community.

Linda Yih, BSc, is a Senior Director in Medical Writing 

Services at Parexel International. As the global lead for the 

People Development initiative, she focuses on onboarding, 

professional development, recruitment, and retention of 

writers as well as managers.

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