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THE QUICK AND THE DIRTY: BEST PRACTICES FOR 
WRITING AND EDITING UNDER TIGHT TIMELINES
Speakers 
J. Kelly Byram, MS, MBA, ELS, Immediate Past President 

and Director-at-Large for New Mexico, AMWA Southwest 

Chapter, Freelance Editor and Writer, Owner of Duke City 

Consulting, LLC, Albuquerque, NM

Theresa E. Singleton, PhD, 2021 AMWA Fellow, Freelance 

Scientific Writer, Owner of Singleton Science, LLC, Beverly, MA

Damiana Chiavolini, MS, PhD, President-Elect of AMWA 

Southwest Chapter, Academic Writer, Editor, and Instructor, 

Richardson, TX

By Stephany Panlilio, MS
In medical writing, the scope and timeline for documents 

varies, depending on the type of document and the client 

for which the document is being prepared. However, these 

2 aspects determine a medical writer’s ability to take on a 

new project. This article summarizes the experiences of Ms 

Byram and Dr Singleton as freelance medical writers and 

editors, and Dr Chiavolini as a medical writer and editor in 

academia, and their best practices for writing and editing 

under tight timelines.

Tight Timelines Versus Short Notice
It is important to first differentiate between a tight time-

line and short notice. In some cases, a client can reach out 

requesting help with a project, but the expectation is the 

project starts right away. This is short notice. On the other 

hand, a client may reach out ahead of time, but provide only 

a short amount of time to prepare a document, hence, a 

tight timeline. In either instance, the first step would be to 

identify the scope of the project and define expectations of 

the medical writer/editor and the client.

 For freelance medical writers/editors, other consider-

ations may include if this is a new client or an established 

client and the time needed to educate on the process. 

Taking on a rush project from a new client is riskier because 

the client may be new to the process in general or may 

not have worked on a given document type. Dr Singleton 

emphasized, “As a freelance medical writer, the best asset I 

have to offer is my word,” and taking on a project that could 

potentially compromise quality could impact a writer’s rep-

utation. There is a lot of value added in taking the time to 

educate a new client on how the process might look, setting 

expectations, and establishing a schedule. If the timeline 

does not account for this, the client may not be a good fit.

 In academia, there is more flexibility in timelines for 

many documents, with the exception of grant proposals. 

However, it is still important to set expectations and educate 

stakeholders on the process and typical turnaround times.

Advice for New Writers and Editors
The first piece of advice given by Ms Byram, Dr Singleton, 

and Dr Chiavolini to new writers when working on a doc-

ument with a tight timeline was to ask questions. Asking 

questions may slow down the process, but it is imperative to 

get as much information as needed upfront from the client 

and to fully understand the agreements being made and to 

clarify deliverables.

 Another critical piece of advice is to set boundaries. 

Freelance writers are typically hired to solve problems that 

a client may not have the experience or expertise to solve. 

Establishing boundaries (eg, typical turnaround times and 

exceptions) and expectations from both the writer and the 

client early in the process is important. Boundaries are not 

meant to create barriers and hinder progress, instead they 

strengthen collaboration between the writer and client, 

keeping the project focused and on target.

Strategies Used When a Project Is Not on Schedule
When working on a tight timeline, every minute matters. If 

a risk arises that could potentially cause a project timeline 

to not be met, the best strategy is communication. Reaching 

out to the project team as soon as possible is critical. It also 

provides the opportunity to ask questions. Is the scope of 

the work negotiable? Is it possible to focus on the key mes-

sages of the document rather than the language? If the proj-

ect team is not providing the information needed to author 

pertinent sections of the document, reach out to the prin-

cipal investigator for assistance; for example, ask whether 

there is a possibility for timeline extension.

 Proactively setting expectations and maintaining clear 

communication throughout a project can help to keep the 

project on schedule.

Tools
A variety of tools are available to assist with authoring, edit-

ing, and composing documents of all types, and ensuring 

timelines are met. Examples of tools utilized by Ms Byram, 

Dr Singleton, and Dr Chiavolini for different documents are 

provided below.

• CONSORT (Consolidated Standards of Reporting Trials) 

guidelines and extensions for writing manuscripts

• Plain language guidelines (eg, Multi-Regional Clinical 

Trials Center’s Clinical Research Glossary, released in 

June 2021)

• Client-specific style guide cheat sheets

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AMWAJournal.org     27Session Reports

• Second (or even third) computer monitor

• Printouts of grant request for proposals and request 

for applications

• Templates for writers

• Glossaries from cancer centers or other stakeholders

• Digitally curating information

• Time tracking/management tools

• Optimizing software already in use

• Checklists and detailed project notetaking

 A medical writer’s ability to take on new projects 

depends on the scope and timeline for a given document. 

Clear communication, educating the client, and setting 

expectations and boundaries upfront are needed to ensure 

the project is completed according to the timeline, without 

compromising quality. In their presentation, Ms Byram, Dr 

Singleton, and Dr Chiavolini provided several strategies for 

assessing the ability to take on a project with a tight time-

line, as well as several tools for creating high-quality docu-

ments within that timeline.

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

Author declaration and disclosures: The authors note no com-
mercial associations that may pose a conflict of interest in rela-
tion to this article.

Author contact: stephany.panlilio@gilead.com

* * *

TIME TO CLOCK IN: APPLYING MANUFACTURING 
BEST PRACTICES TO CONSISTENTLY AND 
EFFICIENTLY PRODUCE HIGH-QUALITY 
DOCUMENTS
Speaker 
Jenni Pickett, PhD, Whitsell Innovations, Inc.,  

Chapel Hill, NC

Mary Ellis Bogden, BA, Whitsell Innovations, Inc.,  

Chapel Hill, NC

By Stephany Panlilio, MS
Regulatory writing and manufacturing have many com-

monalities. As with manufactured products, regulatory doc-

uments should be produced at a reasonable cost, completed 

per an agreed upon timeline, be fit for intended purpose, 

and should meet a set of corporate, legal, and customer 

standards. What can regulatory writers learn from advances 

in manufacturing processes?

Manufacturing Best Practice Philosophies
Many modern manufacturing processes and principles 

came from the car manufacturer, Toyota. The Toyota Way 

operates under 4 driving principles.1 These principles can 

also be applied to medical writing, as described below.

• Long-term Philosophy – Forward Thinking.

  Focusing on the processes used to create products or 

documents can help improve efficiency over time.

• Add Value to the Organization by Developing Your 
People and Partners.

  In manufacturing and regulatory writing, ensuring 

that team members have the right skills is essential.

• The Right Process Will Produce the Right Results.

  A robust process will ensure a high-quality product.

• Continuously Solving Root Problems Drives 
Organizational Learning.

  Manufacturers and regulatory writers should develop 

and maintain a system to identify root causes and 

quickly address issues.

Good Regulatory Writing Practice
Manufacturers of pharmaceutical products must adhere 

to Good Manufacturing Practice (GMP) to mitigate risk. A 

robust GMP quality system includes training people; con-

trolling starting materials and equipment; clearly defining 

manufacturing, packaging, and storage processes; testing 

for quality; and documenting each step.

 To produce high-quality documents, the following are 

necessary: trained people, correct source materials that are 

up-to-date and easy to use, defined processes for the writing 

and review cycles, a quality control review process, and doc-

umenting each step (Figure). So, what would a theoretical 

good regulatory writing practice include?

• Developing the team by ensuring team members have 

the proper education, relevant experience, and knowl-

edge of regulations and company policies can help to 

reduce the risk of human error. Specific risks to your 

team can be evaluated by a gap analysis of critical 

skills. Cultivating a growth mindset culture in which 

employees feel comfortable being noisy in their igno-

rance helps identify critical training needs.

• Creating a Quality Document Profile, similar to the 

Quality Target Product Profile used in GMP, verifies 

the correct template, sources, interpretation, and  

team expectations are used for the document. Using  

a storage management system prevents errors due  

to use of incorrect templates, outdated data, or 

irrelevant sources.

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