





































AMWA Journal / V36 N1 / 2021 / amwa.org    15

SESSION REPORTS

CONFERENCE COVERAGE2020
AMWA

Medical Writing &
Communication
Conference
Dates: TBD
Location: ONLINE

Trends and Opportunities for Medical Communicators

Table 2. Strategies for Meeting Each Time-Management Challenge

Challenge Strategy

Increase  
Efficiency

1. Keep track of project details (eg, OneNote).
2. Use organizational templates.
3. Maintain an accurate schedule of your projects.

Start Quickly  
and  
Effectively

For starting your day…
1. Before leaving work, plan a specific task for the 

beginning of the next day.
2. Work during your most productive working hours.
3. Jumpstart your day with an easy task or get a difficult 

task out of the way early.
4. Maintain big-, medium-, and small-picture plans 

of goals.

For starting a project…
1. Plan time for getting organized.
2. Gather all needed materials before beginning.
3. Begin with easy tasks to familiarize yourself with 

the project.
4. Use a spreadsheet to track parts of the project.

Fight  
Procrastination

1. Work in small time chunks (<3 hours).
2. Enforce breaks to foster and enhance creativity.
3. Use mindless tasks as a break between projects.
4. Commit to working on an undesirable task for 5 min-

utes; this pledge tricks you into working longer.
5. Monitor time realistically to find time sinks.
6. Avoid procrastination pitfalls (eg, Facebook, perfect-

ing PowerPoint slides).

Manage  
Distractions

1. Do one thing at a time.
2. Use a “to-do” checklist.
3. Only check emails at specific times of day.
4. Schedule known interruptions.
5. Postpone your response to nonurgent emails.
6. Use “do not disturb” digital functions when necessary.

Control Your 
Meetings

1. Schedule meetings with enough notice to allow for 
participants’ preparation.

2. Provide a clear agenda.
3. Keep and disseminate accurate and detailed notes.
4. Schedule 15 minutes before and after a meeting to 

allow for final preparation and follow-up.
5. Follow up immediately after the meeting.
6. Communicate clearly.

Protect Your  
Time

1. Keep your calendar up to date; block off work time.
2. Say “no,” if needed, yet offer a solution or an 

alternative.
3. Be clear about expectations (yours and client’s) 

around a project.
4. Frontload your day or week.

TRICKS AND TIPS FOR TIME MANAGEMENT

Speaker
Melissa Christianson, PhD, Whitsell Innovations, Inc, Chapel 

Hill, NC

By Jennifer L. Busch, PhD

“Imagine this: You are promised $86,400 per day for the rest 
of your life. You must use the money each day, or you will 
lose it; none of it carries over to the next day.” Dr Melissa 
Christianson of Whitsell Innovations began her presenta-
tion with this attention-grabbing scenario. Each day 
contains 86,400 seconds, she informed her audience. She 
then offered suggestions for stewarding this nonrenewable 
resource.
 The presentation was divided into 6 sections. Each sec-
tion included a threat to time management, a challenge with 
which to confront each threat, and several strategies for each 
challenge (Tables 1 and 2). Dr Christianson encouraged the 
attendees to modify and personalize her strategy suggestions 
as needed. She concluded her talk with an admonition con-
cerning time: “use it, don’t lose it.”

Table 1. Threats to Optimal Time Management and 
Challenges With Which to Combat Each Threat

Threat Challenge
Inefficient use of time Increase efficiency

Prolonged decision-making 
time 

Start quickly and effectively

A self-reported 4-fold 
increase in procrastination 
within the past 30 years

Fight procrastination

Interruptions (They steal  
90 minutes per day, and  
23 minutes are needed to 
return to productive work 
after each one.) 

Manage distractions

Unproductive time in meet-
ings (Up to half of one’s 
career is spent in meetings.)

Control your meetings

Scarcity mindset (The busier 
a person, the harder it is for 
him/her to decline a new 
request.)

Protect your time

Jennifer L. Busch is an Associate Professor of Biology at Wheaton College, 
Wheaton, IL.

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

Author contact: jennifer.busch@wheaton.edu

mailto:jennifer.busch@wheaton.edu


16    AMWA Journal / V36 N1 / 2021 / amwa.org        

LOW-COST AND LOW-EFFORT WAYS TO 
CREATE INFOGRAPHICS AND VISUALLY 
APPEALING SLIDES

Speaker
Kelly Schrank, MA, ELS, Head Bookworm, Bookworm Editing 

Services LLC, Canastota, NY

By Raeesa Gupte, PhD

Many medical communicators are encountering a rising 
demand for visual-communication services from their clients 
and employers. Visual communication uses charts, graphs, and 
images to simplify and convey complex information or pat-
terns in data. Infographics and slides use elements of visual 
communication to present concepts in a new way.
 At AMWA’s 2020 Medical Writing and Communication 
Conference, Kelly Schrank gave an introduction to and step-by-
step tutorials for non–graphic designers on how to create visu-
ally appealing infographics and slides 
without the use of expensive software. 
“You need to have some patience, will-
ingness to learn PowerPoint a little 
deeper or a new application, and 
some interest in breaking away from 
the words and thinking in a new way 
about how to present data,” Schrank 
emphasized.

What Is an Infographic?
An infographic contains visual 
elements (color coding, graphics, 
and icons), content (time frames, 
statistics, and references), and 
knowledge (facts and deductions). It uses different colors, 
shapes, sizes, fonts, and icons to

• highlight main ideas,

• connect ideas or data, and

• compare and contrast information.

 Color is used to accentuate important data or to separate 
sections of an infographic. Shapes of different sizes are used to 
make comparison easier. Icons may be used as bullets or for 
visual representation of ideas conveyed through text.

Types of Infographics
Infographics may appear in different formats:

• Images

• One- or 2-page handouts

• Rolling infographics that appear on websites and need  

to be scrolled through

Popular types of infographics include

• timelines,

• processes and how-to guides,

• comparisons,

• lists, and

• maps.

How to Create Infographics
An easy way to start building an infographic is to use a tem-
plate. Templates make it easy to choose coordinating colors 
and fonts, thus ensuring style and consistency. In addition, 
templates can be customized by changing design elements and 
including the information you want to present.
 Schrank shared information on applications that have tem-
plates available for infographics (Table 1). Both free and paid 
versions of these applications are available. However, the free 
versions may be watermarked or shared on the website’s public 
domain. To protect client data and privacy, paid versions of the 
applications are preferred.

 To avoid the constraints of commercial infographic soft-
ware, Schrank relies on PowerPoint. She suggests using native 
PowerPoint templates available with Microsoft Office 365. 
Alternatively, you can download templates for free from web-
sites like HubSpot.
 Schrank provided a tutorial on how to customize info-
graphic templates by changing shapes, colors, font sizes, and 
reordering or editing content. Detailed instructions can be 
found in the presentation handout (link in Resources).

How to Create Visually Appealing Slides
Visually appealing slides rely on the same basic elements as 
infographics; they

• make good use of color,

• put text into shapes or SmartArt,

• use different text size to show importance, and

• use icons to add visual interest and connect ideas.

 Instead of using slides with standard bulleted lists or walls 
of text, thematically associated slides can be used to tell an 

Table 1. Comparison of Websites Offering Infographic Templates

Site
Free 

Option?
Able to 
Export?

Public 
Publication?

Watermark/
Branding?

Paid Option 
(Individual)

https://www.canva.com/ Yes Yes No No ~$10/mo

https://piktochart.com/ Yes Yes Yes Yes ~$29/mo

https://www.visme.co/ Yes Yes Yes Yes ~$39/mo 

https://infogram.com/ Yes No Yes Yes ~$19/mo 

https://venngage.com/ Yes No Yes Yes ~$49/mo

https://www.canva.com/
https://piktochart.com/
https://www.visme.co/
https://infogram.com/
https://venngage.com/


AMWA Journal / V36 N1 / 2021 / amwa.org    17

A POWERFUL COMBINATION: THE VALUE OF 
THE WRITER–EDITOR PARTNERSHIP

Speaker
Crystal Herron, PhD, ELS, Managing Director, Redwood Ink, San 

Francisco Bay Area, CA

By Christine Holzmueller, MS

Crystal Herron’s goal in this presentation was not simply to 
deliver information to the audience. Her goal was to ask us 
questions to promote self-reflection on our capabilities and 
careers and to consider the “value a writer–editor partnership 
could bring to our professional endeavors.” She acknowledged 
basic similarities between writers and editors but pointed to 
different qualities and functions of each role. For one, writers 
are creative with words whereas editors analyze and fix text. 
Writers also tend to research a subject, transfer knowledge, and 
become deeply knowledgeable about a subject. Conversely, 
editors focus on examining the writing and revising the text to 
improve it, and they may require less knowledge of the subject 
matter.
 Medical communicators often both write and edit con-
tent. Herron questioned this dual role, noting most people are 
stronger in one area. She listed some pros and cons of being 
a generalist (both roles) compared with being a specialist, 
showing career value in the latter role (Figure). If you special-
ize and form a partnership, Herron believes “you can harness 

your strengths and focus on what you really enjoy” and let your 
partner complement your weak areas.

What Are Some Benefits of This Partnership?
One benefit Herron stressed related to the “curse of knowl-
edge.” The concept is that we omit information, unaware that 
we assume the reader knows what we know. A partner can 
identify these knowledge gaps in a document, find mistakes we 
overlook, and strengthen our writing. They can be a mentor. 
This person can give objective feedback and help divest our 
emotional attachment to our text. A partner can also save us 
time by taking on the refinement of documents. Importantly, a 

effective story. To accomplish this, Microsoft Office 365 pro-
vides powerful tools such as

• templates,

• Design Ideas,

• SmartArt,

• icons, and

• stock images.

 Older versions of PowerPoint do not have infographic tem-
plates or the Design Ideas function and have fewer options 
for SmartArt, icons, and stock images. Although websites like 
Canva, Piktochart, and Visme also provide templates and stock 
images, they are harder to export and may be watermarked.
 Schrank shared the following tips and tricks for creating 
visually appealing slides:
• Convert bulleted lists to SmartArt.
• Convert SmartArt to shapes.
• Use shapes to make your own SmartArt.
• Get inspiration from the Design Ideas function.
• Adjust icons.
• Add stock photos.

 Schrank provided a step-by-step tutorial for each of the 
actions mentioned above. Detailed instructions can be found 
in the presentation handout (link in Resources).

Closing
Kelly Schrank closed the presentation with ideas for infograph-
ics and visually appealing slides by sharing some of her own 
work. She also suggests performing a search on Google Images 
to learn more about the elements of good design, discover new 
design ideas, and see what is currently in vogue.

Resources
Websites for stock images:
https://pixabay.com/
https://unsplash.com/
https://thenounproject.com/
https://www.pexels.com/

Presentation handout:
https://headbookworm.com/wp-content/uploads/2020/10/
AMWA-2020-Low-Cost-and-Low-Effort-Infographics-and-
Visually-Appealing-Slides-Handout.pdf

Raeesa Gupte is a freelance medical and regulatory writer specializing in 
clinical evaluation reports for medical devices.

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

Author contact: raeesagupte@gmail.com

Figure. Pros and cons of generalist compared with specialist.Figure. Pros and cons of generalist compared with specialist.

Specialist Pros 

In-depth knowledge brings 
▼  

Greater value to team & company & 
thus 

▼ 
+ More power 
+ Higher earnings 
+ Greater job security  

Specialist Cons 

Some career inflexibility 

Generalist Cons

• Sacrifice depth for breadth 
of knowledge

• Lower earnings
• Greater job insecurity

Generalist Pros

• Broader knowledge
• More transferrable skills
• Career flexibility

Figure. Pros and cons of generalist compared with specialist.

Specialist Pros

In-depth knowledge brings
▼

Greater value to team & company &
thus

▼
+ More power
+ Higher earnings
+ Greater job security

Specialist Cons

Some career inflexibility

Generalist Cons 

• Sacrifice depth for breadth 
of knowledge 

• Lower earnings 
• Greater job insecurity 

Generalist Pros 

• Broader knowledge 
• More transferrable skills 
• Career flexibility 

SESSION REPORTS

https://pixabay.com/
https://unsplash.com/
https://thenounproject.com/
https://www.pexels.com/
https://headbookworm.com/wp-content/uploads/2020/10/AMWA-2020-Low-Cost-and-Low-Effort-Infographics-and-Visually-Appealing-Slides-Handout.pdf
mailto:raeesagupte@gmail.com


18    AMWA Journal / V36 N1 / 2021 / amwa.org        

EDITING: HARD KNOWLEDGE, SOFT SKILLS

Speaker
Loretta Bohn, ELS, Senior Editor/Writer, RTI International,  

Chapel Hill, NC

Crystal Herron, PhD, ELS, Managing Director, Redwood Ink,  

San Francisco Bay Area, CA 

Erica Goodoff, ELS(D), Senior Scientific Editor, MD Anderson 

Cancer Center, Houston, TX

By Kelly Schrank, MA, ELS

This panel of diverse editors provided their personal experi-
ence and advice in 5 areas: credentials, developing judgement, 
editing on a team and individually, managing expectations, 
and professional development.

Credentials
Although Herron has a doctorate, she doesn’t think you need 
one to be an editor in our field; instead, she thinks you need 
to “be a master of the language and have an interest in the sci-
ence.” Neither Bohn nor Goodoff have degrees in the sciences, 
but Bohn says that you need to be curious, and she enjoys 
“learning about subject matter and learning about language, as 
it changes all the time.”

 Goodoff mentioned Editor in the Life Sciences (ELS) and 
ELS Diplomate [ELS(D)] as credentials that she thinks are well 

known in our field. The ELS credential helped her, she said, 
because “Those letters after my name did help me get inter-
viewed for my current job.” Bohn also mentioned that the 
AMWA Essential Skills certificates and other Medical Writing 
& Communication Conference (MWCC) workshops and  
sessions gave her ways to talk about what she is doing  
and why.

Developing Judgement
The panel posed the questions, “How do you know what to 
do when—how do you develop judgement about when to just 
change something, when to change and query, and when to 
just query, and how do you just let something go?”
 Goodoff defaults to “If you aren’t sure, ask.” It’s nice if you 
have someone to ask, such as a colleague or a message board, 
or you can query the author for clarification. As she and Bohn 
note, “People writing science manuscripts are happy to talk 
about their research.” Bohn also brought up that if and when 
you query might depend on how long you have worked with an 
author or team. Herron added, “It helps to know who you are 
working with. If it’s someone who is new, you want to be a little 
more careful.”
 Queries may also need to be changed over the course of 
a reading; Bohn, Goodoff, and Herron noted that they often 
find their queries answered by the end of the manuscript. They 
agree you should reread your queries before returning the doc-
ument to the author.

partner can make us look good and help us achieve our career 
goals and advancement.

What Are Key Features of an Ideal Partnership?
Herron showed a Venn diagram of 1 skill-based and 3 relation-
ship-based features of an ideal partnership:
• Complementary skills that form a larger skill set that you 

could not accomplish alone.
• Confidence that you can trust and rely on each other.
• Chemistry in how you relate to one another. Both must 

respect and value their partner and work well around deci-
sion-making, disagreements, and conflict resolution.

• Similar values. Herron described this as a core feature to 
figure out ahead of time rather than waiting until “some-
thing pops up and values diverge.” Some questions you need 
to answer are: Do you have similar work ethics (deadline-
driven vs value-driven) and styles (prefer to work early in the 
morning vs later in the day)? Do you have matching com-
munication styles and similar risk-taking behaviors? Do you 
share the same goals and have a similar vision for your part-
nership? Is there equal commitment to the work or a clear 

agreement on whether one person will do more work?

How Can You Find and Establish a Successful Partnership?
To find the right partner, consider colleagues you personally 

worked with that meet the key features of a successful part-
nership. Other approaches are networking at conferences and 
through professional online platforms (eg, LinkedIn), soliciting 
interest through professional organizations (eg, AMWA web-
site), and simply being open and ready for a chance meeting in 
any public space.
 You can establish a partnership at work by searching within 
your company for a viable candidate. Another option is to con-
tract with a consultant for a trial period to see if it works well 
and then hire them or someone else as an employee. If you are 
self-employed, you might draw up a contract agreement and 
establish a formal partnership.
 Herron ended with several questions to deepen our consid-
eration of the value added from a writer–editor partnership:

1. What is your vision?

2. What are your strengths and weaknesses?

3. What are your interests and professional goals?

4. What are your company’s goals?

Christine Holzmueller is a Senior Technical Writer for the Johns Hopkins 
University School of Medicine.

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

Author contact: cholzmu1@jhmi.edu

mailto:cholzmu1@jhmi.edu


      AMWA Journal / V36 N1 / 2021 / amwa.org    19

COLLABORATIVE WRITING: ENSURE SUCCESS 
WITH AN EFFECTIVE STRATEGY 

Speaker
Crystal Herron, PhD, ELS, Managing Director, Redwood Ink, San 

Francisco Bay Area, CA

By Sadie van Dyne, PhD

Collaborative writing projects often stir up a mix of emotions 
in the writing professionals tasked with their completion. 
While these collaborative projects can provide an opportu-
nity to learn new skills, generate new ideas, and gain new per-
spectives, negative feelings can overwhelm those involved 
and hinder the writing process. However, before memories of 
collaborative project-induced dread could set in attendees of 
AMWA’s 2020 Medical Writing & Communication Conference, 

Crystal Herron, PhD, ELS, highlighted strategies to use in three 
key phases of the writing process to help rein in those over-
whelming negative emotions.

The Planning Phase
Deriving all the benefits collaborative writing can offer begins 
in the planning stage. Herron recommended attendees use a 
project-management approach. This approach includes creat-
ing a feasible schedule that takes the project scope, work style 
of team members, and prior obligations into consideration. 
Team members should agree on a file naming convention that 
works well for everyone. Creating an organized storage struc-
ture (Figure) can also help streamline the writing process. 
Herron also offered this helpful organizational tip: archive 
older versions of files and store the most up-to-date version of 
a document in each version folder.

Editing on a Team and Individually
Bohn, Goodoff, and Herron were all mentored by more expe-
rienced editors earlier in their careers; these senior editors 
provided feedback and helped them get up to speed with their 
companies’ ways of doing things. More broadly, Herron also 
found it helpful to see how these more senior editors “edited 
documents and to learn from that.”
 Bohn discussed the advantages of editing and working with 
a team of editors as having others who “get” what you do, who 
can assist when you are overbooked, and who can help when 
you are struggling with questions or internal clients. As some-
one with her own business, Herron has a network of editors 
she works with, whom she can ask for assistance when she has 
too much work.

Managing Expectations
Bohn can ask editors on her team to assist if there is not 
enough time to meet an internal client’s deadline. Goodoff 
said that in her work, she has to balance time with thorough-
ness and prioritize certain types of documents over others 
(for example, grants over manuscripts). She provides authors 
with a time estimate for editing that bakes in the other work 
ahead of the new project. Bohn said that one way to manage 
expectations is to stay in contact with internal clients through 
a monthly email to ask them about upcoming work. Herron’s 
approach is to underpromise and overdeliver, so she has a 
cushion if things don’t go as planned but leaves clients happy if 
the work goes well. All mentioned the helpfulness of discussing 
the levels of edit with authors/clients and which level can be 
accommodated within their timelines. Bohn’s team also pro-
vides a calculator to authors so they can estimate their projects 
before submitting.

Professional Development
Goodoff started off this discussion with 3 things she tries to 
work on. She explains, “It’s always a good idea to brush up on 

skills, especially things that you don’t see every single day but 
that you see often enough,” like statistics. Despite having a 
writing and editing background, she thinks brushing up on 
grammar gives her the vocabulary to explain to authors why 
she is making certain changes to their writing. She also likes 
to learn Word tips and tricks, saying she “finds some new little 
trick every single time.”
 Herron believes it “improves your work” to put in the time 
for professional development. She believes that if you get cer-
tificates, you can make up for the cost by giving yourself a pay 
bump. To make sure she spends time on professional devel-
opment, she adds it to her calendar on her historically slower 
days. Sometimes she just spends an extended lunch time read-
ing up on something or squeezes in just 15 minutes of reading 
here and there.
 Bohn liked Herron’s idea of “making it bite-sized” and 
focusing on 1 idea and what you can read/learn in 15 minutes.

Tips:
Erica Goodoff: If you’re early in your career, the ELS credential 
is worth it.
Loretta Bohn: Always go back and reread your queries when 
done editing the full document.
Crystal Herron: Keep a file of boilerplate comments: just copy 
and paste into comments. (Bonus from chat: use AutoCorrect 
to insert boilerplate comments or create macros to insert them 
into docs.)
Crystal Herron: Focus on one thing a month to learn/brush up 
on skills. (Bonus: teach it to others on a blog to learn it better.)

Kelly Schrank is a freelance medical editor and technical writer in 

Canastota, NY, and the Head Bookworm at Bookworm Editing  

Services LLC.

Author declaration and disclosures: The author notes no commercial 

associations that may pose a conflict of interest in relation to this article.

Author contact: kelly@headbookworm.com

SESSION REPORTS

mailto:kelly@headbookworm.com


20 AMWA Journal / V36 N1 / 2021 / amwa.org 

STRATEGIES FOR EFFECTIVE RISK 
COMMUNICATION 

Speaker
Melissa Christianson, PhD, Medical Writer and Consultant, 

Whitsell Innovations, Inc., Chapel Hill, NC

By Núria Waddington Negrão, PhD

Good risk communication is key for empowering patients 

and the public in general to make informed decisions about 
their health. However, since risk communication involves an 
interplay of complex mathematical concepts, personal beliefs, 
and emotions, effective risk communication can be hard to 
achieve. For example, if we compare some of the things that 
people are most afraid of, such as terrorist attacks, gun crime, 
and bird flu, with the things that cause the most deaths, car-
diovascular disease and cancer, we see that there is a discon-
nect in society between perceived risk and actual risk. 

 Identifying a strong leader who can take on responsibility 
is also a necessity during the planning phase. General duties of 
the team leader include the following:
1. Managing deadlines
2. Updating team members
3. Scheduling and directing meetings
4. Combining drafted sections
5. Coordinating with editors
6. Proofreading
7. Submitting final product
8. Following up with client

The Writing Phase
Herron discussed three different collaborative writing meth-
ods: layering, combining, and stitching. The layering method 
involves the team meeting to discuss the content and over-
all direction of the project while one person (usually the team 
leader) writes the first draft. The draft is then sent to the team 
members, who then weave, or layer, their ideas into the  
existing text. This method allows for a more continuous  
writing style.
 The combining method of writing allows for each team 
member to contribute written content. The team meets to dis-
cuss content and outlines major themes or sections. Each sec-
tion is delegated to a team member and returned to the team 
leader. The leader then combines each section into a compre-
hensive document. This method is time-efficient and allows for 
each writer to use their strengths.
 Finally, the stitching method takes a highly structured and 
focused approach. The team meets to discuss content and 
outlines each paragraph, including topic sentences. Team 

members are assigned a specific paragraph and the team 
leader stitches each paragraph together. The stitched docu-
ment is then returned to the team to refine. While this method 
does require more meetings to plan specific content, the time 
invested up-front can ultimately help save time later.

The Editing Phase
Establishing an efficient editing process is critical in collabora-
tive writing. Herron discussed the pros and cons of two differ-
ent review styles. First, she described in-parallel editing as a 
process in which the team leader sends the document to each 
team member to review simultaneously. The leader is then 
responsible for incorporating revisions into one document. 
Incorporating and keeping track of each author’s edits can be 
challenging for the team leader. Similarly, team members may 
make duplicate edits or edit an old draft. This can introduce 
inefficiencies, as each team member is unable to see other 
authors’ perspectives and may not be updated about the status 
of the project. Overall, Herron discouraged attendees from 
using this method of editing.
 In-series editing is a time- and effort-saving alternative. 
The team leader sends a draft to Author 1 to make edits. In 
turn, Author 1 sends the edited draft to Author 2 for review. The 
series continues until each author has edited the document, 
which is then returned to the leader. This method eliminates 
the possibility of duplicate edits. Furthermore, each author can 
see the revisions other authors suggest, making for a more effi-
cient process.

Conclusion
Overall, Herron reminded attendees the best process to follow 
in collaborative writing projects is the one that works for your 
team. Considering the members of the team, knowing their 
strengths and weaknesses, and knowing each team member’s 
professional goals can help identify the most appropriate meth-
ods to use throughout all major phases of the collaborative 
writing process.

Sadie van Dyne is a freelance medical writer based in Buffalo, NY.

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

Author contact: skdierschke@gmail.com

Figure. Example file structure.

mailto:skdierschke@gmail.com


      AMWA Journal / V36 N1 / 2021 / amwa.org    21

 In her talk, Dr. Melissa Christianson, a Medical Writer and 
Consultant at Whitsell Innovations, Inc., defined risk as “the 
probability of the occurrence of an event or outcome” and 
emphasized that risk communication is “the open, two-way 
exchange of information and opinion about risk, leading to a 
better understanding of the risk in question and promoting 
better (clinical) decisions about management” with no clear 
right answer.1 “Successful risk communication points out haz-
ards and helps navigate crises and avoid danger.”
 In medical communication, we typically talk about inci-
dence, the number of new cases, prevalence, the total number of 
cases, absolute risk, the probability of an outcome in a popula-
tion, and relative risk, a comparison of the absolute risk between 
2 populations. The role of medical writers is to bring clarity in 
how these concepts are presented to the target audience.
 Dr. Christianson identified 4 major obstacles for clear risk 
communication. The first is that the math involved is hard  
and many people, even college-educated individuals, do 
not have the numeracy skills to “do the basic computations 
that are necessary to understand risk.”2–4 This leads to gen-
eral overestimation of risks and inconsistent interpretation of 
equivalent data. 
 The second obstacle to effective risk communication is 
that we are inconsistent in the way we assess risk.2,5,6 Many 
variables influence our assessment of risk, such as the statisti-
cal measure used to present the risk, the framing of the data, 
mental shortcuts, emotions, and our numeracy and literacy 
skills.7 The speaker gave various examples of how the way the 
risk is described affects the audiences’ perception of the risk 
and consequent decision-making. People understand abso-
lute risk better than relative risk, but presenting the relative 
risk leads to an overestimation of the effect and, therefore, to 
treatment acceptance.3,5,8,9 Studies have shown that how we 
frame the data is extremely important. For example, when told 
that “32% of patients were dead 1 year after treatment,” more 
patients chose to take the treatment than those told that “68% 
of patients were alive 1 year after treatment,” even though 
these 2 statements represent the same risk of death.10

The last 2 obstacles to risk communication are that doctors 
and scientists speak a different language than the public and 
that personal beliefs enter the mix as well. Dr. Christianson 
emphasized the need to be careful with the word “significant,” 
which is normally interpreted as meaning “clinically signifi-
cant” by the general population. 
 Finally, Dr. Christianson presented 6 strategies for better 
risk communication. Strategy number 1 is to start basic, to 
not assume that your audience already understands the back-
ground information, and to clearly define the risk, the time 
interval, and the population. Strategy number 2 is to make 
the math as easy as possible to increase the chance of the 
appropriate interpretation of the numbers. Best practices are 
to use natural frequencies (2 out of 100 people), to use a mix 

of numeric and verbal descriptors (low risk—10%), to present 
the absolute risk or combine it with the relative risk (risk of A 
was 10% and risk of B was 20%), to use visual aids, and to build 
up to multiple levels of precision. Strategy number 3 is to be 
consistent when comparing between different treatments and 
to use the same statistical measure, population, time interval, 
denominator, and framing. Strategy number 4 is to give con-
text, be careful when presenting risk comparisons, and con-
sider using an incremental risk format. For example, present 
the background risk of an outcome regardless of intervention. 
Strategy number 5 is to reduce the emotion by eliminating 
emotive language, using balanced framing, and being open 
about what is known and what is not known. Strategy number 
6 is to write to the audience. Take into consideration the socio-
economic makeup, concerns, habits, and knowledge of your 
audience when writing and “proactively intervene if your audi-
ence will have trouble assessing or acting on the risk.” In sum-
mary, Dr. Christianson advises us to “use our tools wisely” 
when communicating risk.

Núria Waddington Negrão is a freelance medical editor at Cactus 
Communications in Maputo, Mozambique.

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

Author contact: nurianegrao@gmail.com

References
1.  Ahl AS, Acree JA, Gipson PS, McDowell RM, Miller L, McElvaine MD. 

Standardization of nomenclature for animal health risk analysis. Rev Sci 

Tech. 1993;12(4):1045-1053.

2.  Carey M, Herrmann A, Hall A, Mansfield E, Fakes K. Exploring health 

literacy and preferences for risk communication among medical 

oncology patients. PLoS ONE. 2018;13(9):e0203988.

3.  Gigerenzer G, Gaissmaier W, Kurz-Milcke E, Schwartz LM, Woloshin S. 

Helping doctors and patients make sense of health statistics. Psychol Sci 

Public Interest. 2007;8(2):53-96.

4.  Lipkus IM, Samsa G, Rimmer BK. General performance on a numeracy 

scale among highly educated samples. Med Decis Making. 2001;21(1): 

37-44. 

5.  Fagerlin A, Zikmund-Fisher BJ, Ubel PA. Helping patients decide: 

ten steps to better risk communication. J Natl Cancer Inst. 

2011;103(19):1436-1443.

6.  James LC. Legislation and the lay audience: challenges of 

communicating benefit and risk in the light of new regulations. Medical 

Writing. 2015;24(4):195-199.

7.  Rakow T, Heard CL, Newell BR. Meeting three challenges in risk 

communication: phenomena, numbers, and emotions. Pol Ins Behav 

Brain Sci. 2015;2(1):147-156.

8.  Sheridan SL, Pignone MP, Lewis CL. A randomized comparison of 

patients’ understanding of number needed to treat and other common 

risk reduction formats. J Gen Intern Med. 2003;18(11):884-892.

9.  Covey J. A meta-analysis of the effects of presenting treatment benefits 

in different formats. Med Decis Making. 2007;27(5):638-654.

10.  McNeil BJ, Pauker SG, Sox HC Jr, Tversky A. On the elicitation of 

preferences for alternative therapies. N Engl J Med. 1982;306(21): 

1259-1262. 

SESSION REPORTS

mailto:nurianegrao@gmail.com


22 AMWA Journal / V36 N1 / 2021 / amwa.org 

MENTORING PROGRAMS: ONE SIZE MAY NOT 
FIT ALL 

Speaker
Mary Burder, PhD, Senior Medical Writer, Parexel International, 

Durham, NC

By Niada Niederhauser, BS

As the demand for skilled medical writers increases, medical 

communication and regulatory medical writing companies are 

seeing the value of mentorships; however, different mentor-

ships fit different situations. At AMWA’s first virtual conference, 

Parexel International’s Senior Medical Writer, Mary Burder, 

described 3 different mentoring programs and highlighted how 

they can benefit both employees and their companies. The 3 

mentoring programs included new hire mentoring, project 

mentoring, and role shadowing. The benefits of mentoring and 

best practices for implementing mentoring relationships were 

also discussed.

Mentoring programs benefit both companies and employees:

• Mentees can learn new knowledge-based skills, build confi-

dence, and advance their medical writing career. 

• Companies can see improved productivity levels and 

increased employee retention and satisfaction and facilitate 

a culture of growth. 

• Mentoring relationships can foster cross-cultural exchange 

and understanding while improving communication skills.

 When implementing mentoring programs, best practices 

should be developed first to ensure the programs are benefi-

cial and to clearly define the mentor/mentee responsibilities. 

Some practices are specific to certain mentorships, but others 

are applicable to all programs. The most important general 

best practice, according to Burder, is to define the goals of the 

mentorship based on the needs of the mentees before the first 

meeting. During the mentorship, mentees should proactively 

disclose their needs to their mentors to assure the appropriate 

knowledge and skills are conveyed. Scheduling regularly occur-

ring meetings is a must; both mentees and mentors should 

commit to attending. Mentors should encourage mentees to 

propose job-relevant topics for their meetings. Mentors should 

willingly share experiences, both positive and negative, as well 

as be approachable and accessible outside of meetings for 

support and feedback. As the program continues, mentoring 

style should adapt to the mentees’ advancing skill level and job 

responsibilities.

 The first mentoring program discussed in Burder’s presen-

tation was the new hire program, which enables new employ-

ees to acquire specific skills and knowledge needed to excel in 

their job. New hire mentoring differs from onboard training, as 

the latter is the core information conveyed to all new employ-

ees. By contrast, new hire mentoring is focused on helping the 

mentee acquire the knowledge, skills, and understanding of the 

processes and workflows specifically relevant to the new job. 

Mentors should provide examples of well-written documents, 

which should be closely reviewed to highlight key features that 

make the document effective. Mentors should also incorporate 

hands-on training, perhaps allowing mentees to work on small 

parts of the mentors’ projects while the mentors provide guid-

ance and feedback. Effective new hire mentoring programs 

should enable mentees to become self-sufficient more quickly, 

boost confidence, and ensure a smooth adjustment to the new 

job’s responsibilities. 

 Project mentoring, the second program presented by 

Burder, focuses on ensuring current employees achieve spe-

cific new levels of knowledge and skills to take on more chal-

lenging roles so that they are equipped to skillfully complete 

projects and meet clients’ needs. Burder pointed out that line 

managers or team leads usually assign their employees to the 

project mentoring program. Mentors are responsible for guid-

ing mentees on specific document preparation and providing 

feedback on performance. Effective project mentoring pro-

grams enable mentees to acquire new project/role-related 

skills, promote professional development, and may increase 

employee retention and satisfaction.

 Role shadowing, the last program discussed by Burder, 

differs from the other mentoring programs in that men-

tees request the opportunity to acquire knowledge and skills 

needed to transition to new responsibilities or positions 

within the company. Role shadowing exposes mentees to new 

roles, projects, and complex processes while conveying how 

to apply certain job-related skills. It can be either observa-

tional, in which mentees observe meetings and interactions, or 

hands-on, which allows mentees to perform small tasks to be 

reviewed by mentors.

 Burder closed the presentation with a summary of mentor-

ing programs while emphasizing how their success depends on 

determining mentoring objectives before implementation.

Niada Niederhauser is a medical writing and editing student at the 
University of Chicago and freelance writer in Severn, MD.

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

Author contact: niadan@gmail.com

mailto:niadan@gmail.com


AMWA Journal / V36 N1 / 2021 / amwa.org    23

mentee. There are few things that we don’t talk about. … Our 

mentoring relationship helps me grow and learn as much as 

my mentee.”

 So, how do you create a maximal mentoring relationship? 

What is the “secret sauce?” According to Morris, there are 4 

important ingredients to establishing and maintaining this 

valuable connection:

1. Relationship: In maximal mentoring, friendship comes first, 

and the professional relationship comes second.

2. Connection: It is important for the mentor and mentee to 

have a strong connection. They must care about each other’s 

success, be responsive to communication, and create a safe 

space for each other. A firm commitment is required, with 

many maximal mentoring agreements and logistics outlined 

in a document or contract.

3. Acceptance: The mentor and mentee must accept each 

other for who they are with no judgment. There is no hidden 

agenda or pretending to be someone else; the “masks are 

off.” The mentor and mentee can discover their best selves, 

and both are able to take risks within the privacy and safety 

of the relationship.

4. Preferred traits on the part of the mentor and mentee:

a. Trust and mutual respect

b. Interdependence

c. Authenticity

d. Vulnerability

e. Patience

 If maximal mentoring does not sound feasible, Morris 

suggests starting with reverse mentoring. Reverse mentoring 

is when a younger, inexperienced employee is paired with a 

senior executive who is willing to learn. The younger employee 

exposes the executive to issues important to the younger gen-

eration and addresses gaps in the executive’s technology skills. 

This style of mentoring helps the organization retain young 

talented professionals while increasing representation of the 

younger demographic throughout the organization.

 Morris summarizes the most important aspects of building 

a meaningful mentoring relationship as follows:

1. Build a relationship based on candor and trust.

2. Look for opportunities to explore professional goals and 

personal dreams.

3. Be open to give and receive critical feedback, sharing 

successes and mistakes.

Christina Barnes is a freelance medical writer,  
https://www.christinabarnes.com/, Columbus, Ohio

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

Author contact: christina.barnes712@gmail.com

SESSION REPORTS

ANALYSIS OF MENTORING: FROM MARGINAL 
TO MAXIMAL

Speaker
Susan Morris, MEd, CPCC, ACC, Susan Morris Coaching

By Christina Barnes, MSN, RN, CPNP

One of the most important business relationships is the men-

toring relationship. Traditionally, the mentoring relationship 

has been innately hierarchical, with the mentor as the expert 

and the mentee as the junior or apprentice. Morris classi-

fies this type of mentoring as traditional or minimal men-

toring. “Learning goes in one direction, from the mentor to 

the mentee,” Morris says. “The mentee is dependent on the 

mentor.” Morris advocates for moving away from this mini-

mal model and instead adopting a mentoring relationship that 

opens possibilities for both the mentor and the mentee. Morris 

calls this mutually beneficial model of mentoring “maximal 

mentoring,” and she encourages professionals to cultivate this 

type of mentoring relationship within their own network.

What is maximal mentoring? Maximal mentoring is a pro-

fessional relationship between a mentor and a mentee that 

is mutually beneficial. The expectations of both parties are 

exceeded. The mentoring process is not generic, but rather 

is highly customized to the needs of the mentee. There is an 

emphasis on the mentee as a whole person; the focus goes 

beyond career-related needs and goals. The relationship is 

transformational, as both the mentor and mentee change as a 

result of this style of mentoring.

 Traditional or minimal mentoring, in contrast, is a generic 

professional relationship. The mentor has a standardized way 

of mentoring others that is not tailored to the needs of the 

specific mentee. This is usually a tr ansactional relationship or 

exchange; the mentee needs a job, and if the mentor helps the 

mentee find a job, the mentor hopes for access to the men-

tee’s network. The focus in this relationship is solely on career 

development. The mentee is dependent on the mentor, and 

the 2 are not considered to be equals.

 Maximal mentoring requires mentors and mentees to 

move away from the mindset of traditional mentoring. In 

doing this, mentors and mentees can enjoy a relationship 

founded on equality, respect, and trust. “Learning is a two-

way street” in maximal mentoring, says Morris. The mentor 

and mentee are equals, and there is the expectation that they 

will learn from each other. Both the mentor and mentee can 

experience personal and professional growth as a result of this 

relationship. Maximal mentoring can be “positive, uplifting, 

appealing, attractive, and fun,” Morris says. The mentor and 

mentee can expect to have conversations about both profes-

sional and personal matters. Morris quotes a maximal mentor 

who describes these conversations: “I am very close with my 

https://www.christinabarnes.com/
mailto:christina.barnes712@gmail.com


24 AMWA Journal / V36 N1 / 2021 / amwa.org 

KNOWING WHICH BUTTON TO PUSH: 
COMMUNICATING THE VALUE PROPOSITION 
OF MEDICAL WRITING

Speaker
Robin Whitsell, Whitsell Innovations, Inc, Chapel Hill, NC

By Lisa English, PhD

As medical writers, it is essential to understand that everything 

we do communicates our value. Our emails should be free 

of spelling and grammatical errors and highlight our writing 

expertise. Our presentations should have well-prepared slides 

based on a solid understanding of the science involved. We 

need to show others that the document is safe with us and that 

they can put their confidence in us. Scientific knowledge and 

writing expertise alone aren’t enough to do that. There 

is more.

Understanding Team Dynamics

We need to understand our teams. To own the document, we 

need to influence without authority, which is challenging, espe-

cially when team members may be more senior. Understanding 

team dynamics allows us to own any situation and shepherd 

the team and the document toward success.

Mastering Our Reactions

It is equally important to understand what our actions might 

be saying to the team. To do this, we need to be observers of 

our reactions. Try taking private notes during a meeting. When 

something uncomfortable happens, write it down. Include only 

observations, no judgments. After the meeting, evaluate the 

information critically. Understanding our feelings and how they 

manifest in us gives us the power to change them to improve 

our interpersonal effectiveness.

Seeking the Gift of Feedback
What if others seem concerned about our value? In those situ-

ations, it is vital to own the disconnect and ask to reset. When 

seeking feedback from an individual, compliment the person 

on something specific and real to create a connection and con-

firm commitment. If the person does not provide feedback, 

lead them to it, explaining the behavior that’s creating the dis-

connect and asking to learn more. But what if the disconnect is 

with the team? The same basic principles hold, but it’s probably 

best to address it at the beginning of a meeting: “Hi, it seems 

we’re experiencing a rough patch. I’d appreciate your advice 

about the best way to move forward.”

Putting It All Together
Let’s look at a few stereotypical examples of team dynamics  

and how being aware of our feelings and mastering our reac-

tions can help.

Captain Obvious. What happens when a team member 

says something obvious? How do we feel? How do we react? 

Understand both and then own the situation. Try pulling Captain 

Obvious more fully into the conversation. Ask him a question 

related to his expertise and make room for him to answer.

The Interrupter. What happens when someone consistently 

interrupts? Often, if the interrupter is more senior, we think we 

must allow the behavior, but we should not. Again, identify the 

feeling and reaction elicited. Then own the situation. Try prac-

ticing neutral phrases to address this situation. One example 

is “I promise we will get to that, Jack; please, let’s complete this 

discussion point first.”

The Combative. How does a combative team member make 

us feel, react? Owning this situation requires staying neutral, 

being succinct, and redirecting the individual. For example, 

one might say, “Catherine, I hear how important this is to you. 

Maybe we can address it in Section 11. Right now, we need to 

move to comments from Clarice.”

Skill at Leading and Motivating a Team

Although disagreeing may make us feel combative, respectful 

disagreement is often necessary to get the documents right. In 

this situation, we need to maintain a neutral tone and remain 

matter-of-fact. Try posing the disparity as a question. For exam-

ple, one might say, “It seems we are missing a source for the 

data on page 82. How should we resolve this?”

 The value proposition of a medical writer is multifold. It is 

about scientific knowledge and writing expertise, understand-

ing team dynamics, and understanding (and being willing to 

change) ourselves. It’s about getting the document right, not 

being right; about conveying empathy, respect, and dedication; 

and about giving others the benefit of the doubt. As medical 

writers, we need to show up every day as our best selves to do 

our best work because that invites everyone to do the same.

Lisa English is Owner and Principal Medical Writer at Just MedTech,  
San Jose, CA.

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

Author contact: lbenglish@sbcglobal.net

mailto:lbenglish@sbcglobal.net


AMWA Journal / V36 N1 / 2021 / amwa.org    25

WHAT THE BEST MEDICAL WRITERS KNOW 
ABOUT NONCLINICAL DATA

Speaker
Beth Krause, MS, MBA, Senior Medical Writer, RRD International, 

LLC, Rockville, MD

By Stacie Marsh, MPA, CPH, GPC

Medical writers specialize in a variety of fields, such as con-

tinuing medical education, patient education, scientific 

publications, regulatory documents, and research-grant appli-

cations. Writers pursuing Medical Writing Certification (MWC) 

must at least be familiar with each of these areas, and even 

those not pursuing certification benefit from cross-disciplinary 

understanding.

 Ms Krause’s presentation at the AMWA’s 2020 Medical 

Writing & Communication Conference explained the impor-

tance of nonclinical data and studies from a broad context, 

resonating with medical writers from all areas, including those 

with and without expertise in regulatory documents.

Overview of the Drug Development Process
The life cycle of drug development occurs through 4 phases, 

some of which can occur simultaneously. These include

• phase I (relatively small studies focused on establishing 

safety, and clinical pharmacology studies),

• phase II (larger studies focused on evaluating clinical 

efficacy),

• phase III (pivotal, large, randomized, placebo-controlled 

studies with clinical trials to prove clinical efficacy prior to 

marketing authorization), and

• phase IV (large studies to establish processes for ongoing 

safety and efficacy surveillance after a drug is approved 

and marketed).

 The most important function of nonclinical data is to estab-

lish that a drug is safe to be administered to humans. These 

data are submitted with an Investigational New Drug applica-

tion prior to initiating studies in humans. However, the data 

from nonclinical studies may impact the clinical development, 

and thus, clinical documents, throughout a drug’s life cycle.

The Importance of Nonclinical Data in the Drug 
Development Process and Placement of Nonclinical 
Data in Clinical Regulatory Documents
Ms Krause set the stage for writers unfamiliar with regulatory 

documents by explaining the lifecycle of drug development 

within the framework of the “Common Technical Document” 

(CTD) Triangle (Figure).

 Endorsed by the International Council for Harmonisation, 

the CTD Triangle is a standard framework for applications 

for approval of new medical drugs to regulatory authorities 

in the United States, Europe, and Japan. The CTD Framework 

is organized into 5 modules. Most medical writers with reg-

ulatory document expertise focus on Module 5 (Clinical 

Study Reports). However, the preceding module, Module 4 

(Nonclinical Study Reports), includes valuable content that 

impacts the documents in Module 5.

As Ms Krause explained, 

the most important role 

of nonclinical information 

in regulatory documents 

is to provide basic safety 

support for a new chemi-

cal entity (drug) before it is 

tested in humans, includ-

ing a detailed assessment 

of benefits and risks. Thereafter, nonclinical information is 

required throughout development and marketing, including 

the medication packaging.

 Nonclinical data impact risk language, dose selection, 

design elements, and development. For example, nonclini-

cal studies inform risk language in clinical documents such 

as informed consent forms, clinical protocols, general investi-

gational plans, and investigator brochures. Nonclinical stud-

ies also predict potential side effects when it is too difficult or 

unethical to test in humans (ie, reproductive side effects).

 Nonclinical data are also valuable in informing first-in-

human dose selection by establishing starting doses and safety 

margins, as well as dosing regimens, on the basis of findings 

in toxicology studies. Additionally, nonclinical data inform the 

rest of the drug development process by determining the need 

for additional clinical studies, identifying potential new indica-

tions/targets, and even terminating development if the safety 

profile is poor.

 Following an overview of the basics of the drug develop-

ment process and the value of nonclinical data therein,  

Figure. The CTD triangle. The CTD is organized into 5 modules. 
Module 1 is region specific, and modules 2, 3, 4, and 5 are  
intended to be common for all regions. CTD, Common  
Technical Document.

“Nonclinical data enrich the overall 

understanding of a drug during the 

development and approval process, 

starting well before new drugs are 

first tested in humans.” 

—Beth Krause

SESSION REPORTS

The CTD

Not part of 
the CTD

Module 2

Regional
administrative

information
Module 1

Clinical
overview

Non-clinical
summary

Non-clinical
overview

Quality  
overall

summary
Clinical

summary

Quality

Module 3

Non-clinical
study reports

Module 4 Module 5

Clinical study
reports



26 AMWA Journal / V36 N1 / 2021 / amwa.org 

JAMA Network /  
AMA Manual of Style
Stacy L. Christiansen

stylemanual@jamanetwork.org

The JAMA Network publishes more than a dozen medical  

journals, including JAMA, JAMA Network Open, and an array of 

specialty journals. The JAMA Network also creates and updates 

the AMA Manual of Style and publishes the Users’ Guides to the 

Medical Literature. In addition, the International Congress on 

Peer Review and Scientific Publication is hosted by the  

JAMA Network.

 The AMA Manual of Style is a comprehensive reference 

for medical writers, editors, and publishers. Written by JAMA 

Network editors and published by Oxford University Press, the 

11th edition has been thoroughly revised and updated. There is 

guidance on citing sources; data displays; grammar, punctua-

tion, and capitalization; correct and preferred usage; abbrevia-

tions; nomenclature; ethical/legal issues and editorial policies; 

units of measure; and numbers, study design, and statistics. 

The online version is fully searchable and offers additional 

content, including news, quizzes for educational or train-

ing purposes, updates, an interactive calculator, and links to 

social-media features.

For additional information, visit amamanualofstyle.com.

Merck & Co, Inc
Kim Jochman

kimberly.jochman@merck.com

The Merck Medical Writing department creates high-quality 

regulatory documents to support Merck’s global development 

pipeline. We are advancing the medical writing profession by 

continually adapting to the ever-changing regulatory writ-

ing landscape with new technology, pilot programs with the 

U.S. Food and Drug Administration, and recruitment of talent 

from diverse backgrounds who have the skills we need for the 

future. Our commitment to professional development has led 

to the creation of a hands-on entry-level training program that 

leverages industry-level recommendations on the competen-

cies and training needed to be a successful regulatory medi-

cal writer. We also ensure individualized growth opportunities, 

such as rotations and mentoring experiences, for our more 

seasoned team members. Our focus on innovation and profes-

sional development allows us to drive efficiency while main-

taining the highest quality.

 To learn more about Merck’s drive to invent for a more 

hopeful future, along with our dedication to diversity and 

inclusion and our strong sense of corporate responsibility, visit 

www.merck.com/company-overview/.

Ms Krause provided a detailed explanation of the role of  

nonclinical data within Module 4. The 3 main categories in 

Module 4 include

• pharmacology (how a drug works, how a drug may affect 

organ systems secondary to its main target, and how 

coadministration of drugs may affect how they work),

• pharmacokinetics (how a drug is absorbed, distributed, 

metabolized, and excreted from the body as well as the 

potential for drug interactions), and

• toxicology (how a drug may cause adverse effects, including 

single-dose toxicity, repeat-dose toxicity, and the potential 

for genotoxicity and carcinogenicity).

 Ms Krause explained how to link nonclinical data in 

Module 4 to clinical documents with which regulatory medi-

cal writers may be more familiar (typically Module 5) by using 

a fictional example of a new chemical entity compared with a 

drug that is repositioned for a new indication.

Importance for All Medical Writers

Even medical writers who focus on other areas of medical writ-

ing, with little or no experience with regulatory documents, 

benefit from this presentation by its comprehensible overview 

of drug development and how nonclinical data fit in.

 Although regulatory writing is a popular area of the medi-

cal writing profession, it is often limited to those with medical 

or pharmaceutical backgrounds or early-career experience and 

can be intimidating to those who specialize in other areas. The 

content in Ms Krause’s presentation is particularly salient for 

writers without a medical or pharmaceutical background, given 

the myriad aspects of the drug development and approval pro-

cess that require proper placement of nonclinical data.

Stacie Marsh is a medical writer at Words for Good, Inc, and is based in 
the Charlotte, NC, area.

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

Author contact: stacie@wordsforgood.com

EXHIBITOR PRECIS

mailto:stylemanual@jamanetwork.org
mailto:kimberly.jochman@merck.com
http://www.merck.com/company-overview/
mailto:stacie@wordsforgood.com
https://www.amamanualofstyle.com/


AMWA Journal / V36 N1 / 2021 / amwa.org    27

Synchrogenix, a Certara Company

Demetrius Carter

demetrius.carter@synchrogenix.com

Assuring Regulatory Success

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University of California  

San Diego Extension

Robert Houghtaling

rhoughtaling@ucsd.edu

The Medical Writing Certificate program at the University of 

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graduates with the foundational knowledge and skills needed  

to work as a medical writer in the commercial sector, govern-

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 The program culminates in an applied Capstone project, 

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Program faculty are dedicated educators and nationally  

recognized experts in their medical writing specialties.

 For more information on the UCSD Extension Medical 

Writing program and our faculty, visit https://extension.ucsd.

edu/courses-and-programs/medical-writing-courses.

* * *

Oxford University Press 

Abby Gross

abby.gross@oup.com  or

Linnie Greene

linnie.greene@oup.com

Oxford University Press is the proud publisher of the AMA 

Manual of Style, 11th edition, the must-have resource for 

anyone involved in medical, health, and scientific publishing. 

Written by an expert committee of JAMA Network editors, this 

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 For additional information, please visit  

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https://certara.com/synchrogenix
mailto:rhoughtaling@ucsd.edu
https://extension.ucsd.edu/courses-and-programs/medical-writing-courses
mailto:abby.gross@oup.com
mailto:linnie.greene@oup.com
https://www.amamanualofstyle.com/
mailto:cwarren@therabusiness.com


28    AMWA Journal / V36 N1 / 2021 / amwa.org        

Whitsell Innovations, Inc,  

Connie Morris

connie.morris@whitsellinnovations.com

Whitsell Innovations (WI), Inc, is a 

woman-owned, full-service medical and scientific writing 

company focusing on the needs of the pharmaceutical, bio-

tech, and device industries.

 We speak science. We are a team of experts who deliver 

high-quality medical, scientific, and regulatory writing. WI is 

a boutique group composed of individuals with years of expe-

rience, in both industry and medical writing, and most with 

advanced degrees at the doctoral level. Our subject-matter 

expertise capitalizes on our education and our deep industry 

experience.

 We integrate with your team. Our broad range of services 

meet the needs of our expansive client portfolio, ranging from 

small US-based clients to large international clients. WI offers 

a uniquely integrated approach for communicating complex 

corporate and scientific data and ideas. We seamlessly engage 

with client teams to ensure successful progress and comple-

tion of each project.

 We focus on perfection. Our experience and training allow 

us to pay attention to every detail. Our singular focus is perfect 

medical, scientific, and regulatory writing with clarity, reliabil-

ity, and integrity.

We are Whitsell Innovations. We speak science and we love 

what we do!

https://www.whitsellinnovations.com

* * *

PerfectIt 

Daniel Heuman 

daniel@intelligentediting.com

All it takes is one typo for readers to question the accuracy of a 

submission or publication. 

 You can spend hours searching for each typo manually. Or 

you can use PerfectIt™ to help find consistency mistakes and 

other common typos faster so you can focus on the science. 

 PerfectIt is used by thousands of medical writers and 

editors around the world, including the medical writing teams 

at six of the world’s top ten pharmaceutical firms. AMWA 

members voted it one of their most essential tools. 

Get the free trial for MS Word today: 

https://intelligentediting.com

* * *

Trilogy Writing & Consulting

Magnolia Correa

magnolia.correa@trilogywriting.com

At Trilogy, medical writing is our pas-

sion. As specialists in clinical and non-

clinical regulatory documentation, we 

provide a service that is more than just writing. Our writers 

are integral parts of our clients’ teams, proactively planning, 

coordinating, and writing their clinical documents to meet 

timelines, with a readability that reduces the time for review 

and approval. We have been helping our satisfied customers—

pharmaceutical companies and clinical research organizations 

of all sizes, worldwide—to streamline their documentation 

processes for over 18 years.

 Trilogy currently has more than 65 writers, who are located 

in Europe and North America. We pride ourselves on our “dedi-

cated team” approach when developing documents, which 

greatly reduces the time needed for production and ensures 

much greater levels of continuity throughout an entire devel-

opment program. We are happy to take on any project, from 

individual documents to supporting an entire clinical-devel-

opment program. Please get in touch with us to find out how 

we can support your clinical and nonclinical teams with their 

document needs.

https://www.trilogywriting.com/

Contact marketing@amwa.org  
for information about exhibitor  
and sponsorship opportunities.

Plan to share your  
products and services  

at #AMWA2021

mailto:connie.morris@whitsellinnovations.com
https://www.whitsellinnovations.com
mailto:daniel@intelligentediting.com
https://intelligentediting.com
mailto:magnolia.correa@trilogywriting.com
https://www.trilogywriting.com/
mailto:marketing@amwa.org



