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a clear as could it be. Additionally, he suggested adding a 

plain language abstract to the study synopsis, especially 

when the sponsor does not plan to provide a separate plain 

language summary. Other handy tools include developing a 

plain language glossary and templates.

Prepare for Redaction and Anonymization
For participant information, AVOID the following:

• using pronouns in patient narratives; consider using 

“the patient” instead, 

• using “verbatims” with quotes by the investigator, as 

these may include unique circumstances that could 

describe a patient, or 

• including patient IDs in images of tables. If patient IDs 

are required, then either include tables with selectable 

text (instead of copied as an image) or keep table for-

matting consistent across all images to ease redaction.

For study or sponsor staff information and other identifiers, 

AVOID the following:

• adding names of the study staff with their organiza-

tional titles; instead, use only their study role,

• including contact information such as fax, phone, or 

email,

• incorporating CVs or certificates or adding them to an 

appendix,

• adding personal identifiers to bookmarks (such as 

patient IDs, names, study admin), or

• providing treatment allocation and group information 

throughout the document.

Other final considerations: 

• Limit duplication that requires duplicate redactions, 

for example, providing a table with patient narrative 

information followed by text with some of the same 

information.

• In the sample Case Study Report Case Report Form 

(CRF), use a clearly fake patient ID like XXXX or 0000 

(not even “1234”).

• Aim to keep page numbering consistent between the 

CSR and the PDF copy to help remove out-of-scope 

information.

• Because foreign language pages are out of scope, you 

may keep these in an appendix or remove them.

 These are some best practices for medical writing with 

a disclosure mindset. It is part of your job as a regulatory 

medical writer to have a basic knowledge of disclosure  

regulations and support trial transparency. 

Nisreen Shumayrikh is a medical writer and scientific communi-
cator at Guanine Medical in Vancouver, BC, Canada 

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

Author contact: nisreen@guaninemedical.com

* * *

BRIDGING THE GAP: TRANSITIONING INTO 
REGULATORY MEDICAL WRITING
Speakers 
Amber Carr, PhD, Medical Writer, Merck, Rahway, NJ

Savannah Mageau, PharmD, Medical Writer, Merck, 

Rahway, NJ

Shengjie Xu, PhD, Medical Writer, Merck, Rahway, NJ

By Stephany Panlilio, MS
The role of a medical writer is everchanging and requires a 

range of technical knowledge and soft skills to create cohe-

sive documents in preparation for submission to regulatory 

health authorities. Medical writers come from a variety of 

different backgrounds with varying levels of experience. 

For those looking to enter the field, there are a number 

of transferable skills from previous experiences, training 

opportunities, and techniques to bridge knowledge gaps in 

preparation for transitioning into a regulatory medical writ-

ing role. This article summarizes the experiences of Dr Carr, 

Dr Mageau, and Dr Xu as they each transitioned into regula-

tory medical writing.

Skills Leveraged from Previous Experiences
In their presentation, Dr Carr, Dr Mageau, and Dr Xu shared 

their previous roles in experimental research, pharmacy 

practice, computational research, and teaching and medical 

communication and the skills they gained from each that 

were transferable to their role as medical writers. The skills 

they found most applicable to medical writing are summa-

rized into the following 3 categories: soft skills, technical 

skills, and core knowledge.

Soft Skills
The soft skills of self-management and project management 

that Dr Xu gained from her time in experimental research 

have helped in her medical writing role. Managing time, set-

ting priorities, and working independently are critical as a 

medical writer, and developing these skills can increase  

productivity. Medical writers must be able to manage  

multiple project timelines and have the flexibility to adjust 

when something unexpected arises (eg, shifting research 

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AMWAJournal.org     18Session Reports

direction, delays at clinical sites, etc.). In addition to  

managing timelines, managing resources is important for a  

successful submission, as is continuously reassessing those 

resources as the project develops.

 Dr Mageau was able to apply the leadership skills she 

developed from her previous experience in pharmacy prac-

tice. In medical writing, leadership is important because 

writers coordinate with several functional areas to produce 

documents, which includes coordinating meetings and 

leading presentations.

Technical Skills
Dr Carr found that her experiences in computational 

research and teaching and medical communication devel-

oped her technical skills for process proficiency and scien-

tific communication, which in turn proved to be applicable 

to her role in medical writing. As a medical writer, the ability 

to manage and organize multiple projects concurrently and 

keep a process-driven approach saves time and can lead 

to streamlining processes in the future. As medical writing 

becomes more dependent on technology, it is important  

to have medical writers who are proficient in different  

software and who are willing to troubleshoot or test soft-

ware as needed.

 Scientific communication is another soft skill Dr Carr 

was able to bring from her previous experience to medical 

writing. Having a background in scientific communication 

taught her how to write for her audience by ensuring that 

the appropriate level of detail is included for the intended 

audience as well as modelling scientific thinking while 

keeping the audience engaged. Lastly, being able to com-

municate scientific information includes using evidence to 

craft a coherent story and to support the conclusions, as is 

done when writing clinical study reports and other regula-

tory documents.

Core Knowledge
In her pharmacy practice experience, Dr Mageau was able 

to gain real-world experience in several therapeutic areas, 

which helped to develop her core knowledge of different dis-

ease states, which is especially helpful when writing clinical 

regulatory documents. She was also able to utilize her expe-

rience collaborating with multidisciplinary teams as well 

as leading discussion and presentations, as medical writers 

build documents with several cross-functional teams.

Training Opportunities
Numerous opportunities to further develop knowledge and 

understanding of the drug development process, clinical 

research, and medical writing are available to those look-

ing to enter the field. Training courses recommended by 

Dr Carr, Dr Mageau, and Dr Xu included the Introduction 

to the Principles and Practice of Clinical Research offered 

by the National Institutes of Health (NIH), the Regulatory 

Affairs Certification Preparation Program offered by the 

North Carolina Regulatory Affairs Forum, and Making 

Medicines: The Process of Drug Development certificate 

program offered by Eli Lilly.

 In addition to training courses, Dr Xu had the opportu-

nity to serve on an Institutional Review Board (IRB) where 

she gained hands-on experience. When serving on the IRB, 

Dr Xu learned local and international regulations, including 

good clinical practice, as well as ethical principles for clinical 

research. This experience also gave her the opportunity to 

review clinical study protocols and Investigator’s Brochures 

(IBs), which is applicable to her role as a medical writer.

 Dr Mageau participated in an internship at 

GlaxoSmithKline, where she gained experience in the 

Global Medical Sciences and Clinical Pharmacology groups. 

From this experience, she compiled data and used source 

documents, such as clinical study reports and IBs, to write 

manuscripts, abstracts, and presentations. 

 Another opportunity to expand knowledge and gain 

experience in the industry is by networking, as suggested by 

Dr Carr. Joining local and national chapters of organizations 

like AMWA provides opportunities for communicating  

and creating relationships with others in the field and  

learning from their experiences, finding training recom-

mendations, and attending conferences to learn what is  

new in the industry.

Bridging Knowledge Gaps
All 3 presenters shared their experiences bridging the gaps 

in their knowledge in their training course at Merck, which 

follows the AMWA Recommended Training Outline and 

focuses on 3 key areas: core knowledge and skills, docu-

ments, and soft skills.

Core Knowledge and Skills
Dr Mageau recommended the AMWA Essential Skills Certi-

ficate Program, which provides a background for the core 

knowledge in medical communication. In addition, taking 

this course also shows a commitment to developing profes-

sionally, further enhancing credibility as a medical writer.

 Development of technical aptitude as a medical writer 

is important to enhance productivity and efficiency in writ-

ing documents. As regulatory documents are now primar-

ily digital, Microsoft Word is a helpful authoring tool. In 

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AMWAJournal.org     19Session Reports

addition, utilizing a collaborative authoring platform, such 

as SharePoint, enables multiple writers to work on a doc-

ument concurrently. As documents are further developed, 

tools such as table, listing, and figure tools are available to 

help format and present data clearly to reviewers. Lastly, as 

a large amount of data are presented in regulatory docu-

ments, it is essential to have a quality control tool in place to 

ensure a document is ready for submission.

Documents
In the rotational training program at Merck, Drs Carr, 

Mageau, and Xu were able to gain hands-on experience 

and participate in shadowing opportunities to develop an 

understanding of the types of documents that medical writ-

ers author. During that time, they learned how documents 

were built during the authoring process, shadowed the 

Quality Control group, attended consensus meetings, and 

eventually transitioned to being lead authors.

Soft Skills
Lastly, further developing self-management and people 

skills helps to strengthen a medical writer’s ability to work 

collaboratively even while remote, build connections, and 

maintain high productivity. Medical writers are responsi-

ble for leading meetings and managing a team to build a 

cohesive document. Having strong people skills is critical to 

achieving this goal.

 When transitioning into a regulatory medical writing 

role, there are several transferrable skills that can be utilized 

from previous experiences, including soft skills, technical 

skills, and core knowledge. To further prepare new writers, 

numerous training opportunities are offered through orga-

nizations such as NIH, local regulatory affairs forums, and 

more. Lastly, AMWA provides a recommended training out-

line focusing on core knowledge and skills, documents, and 

soft skills that further helps to bridge any knowledge gaps 

for new writers entering the everchanging field.

Stephany Panlilio is a Senior Associate in Medical Writing at 
Gilead Sciences, Inc. (Foster City, CA)

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

Author contact:  stephany.panlilio@gilead.com

* * *

GROWING YOUR CAREER AS AN EDITOR 
Speakers 
Crystal Herron, PhD, ELS, Redwood Ink, San Francisco Bay 

Area, CA

Loretta Bohn, ELS, RTI International, Research Triangle 

Park, NC

Erica Goodoff, ELS(D), The University of Texas MD 

Anderson Cancer Center, Houston, TX

By Angela Trenkle, BS
Being a strong editor is a skill set that can open many doors 

in the medical writing field. In this panel session, three edi-

tors discussed some of their tips and tricks for navigating 

the world of editors.

How Editing and Writing Differ 
Ms Goodoff began by explaining that writing is almost like 

a brain dump; you are just writing everything that is in your 

mind with regard to the topic. Editing requires more of a crit-

ical thinking piece: I have content, but how do I shape it? Dr 

Herron added that emotional intelligence is also an import-

ant skill to have for editing so that you can eloquently explain 

your proposed changes to authors. Ms Bohn also emphasized 

that editing is not personal and that editors are looking at the 

writing from a different perspective—advocating for readers. 

All three of these editors mentioned that it was important to 

explain why you’re recommending the changes and to back 

up your suggestions with data and resources.

Key Skills for Editing Grant Proposals 
Ms Goodoff began by stating that a key skill for editing grant 

proposals is to find ways to make it as effortless as possible 

to read the text and to make sure that the logic flows and 

ties back to the main objective. Dr Herron emphasized that 

the storytelling element of the research project is important, 

which includes how the research project is expected to end. 

Ms Bohn pointed out the navigation pane in Word, which 

is a good way to look at pieces of a grant for consistency. All 

three mentioned the importance of cutting down the length 

and wording and ensuring that the entire document is con-

sistent in flow.

Teaching/Mentoring Editors 
Ms Goodoff began by discussing how coaching new col-

leagues in editing differs from editing when the client is the 

only one who will see your edits. It can be helpful to teach 

new editors because it helps you to become a better editor, 

but you must find that balance between fixing the prob-

lems and teaching the new editor to do it themselves. With 

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