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As medical writers, you’ve undoubtedly experienced 

the need for leadership in your writing projects. 

Have you been conflicted as to how to best estab-

lish leadership despite having no clear authority over team 

members? How can we motivate teams to accomplish medi-

cal writing goals and help deliver quality documents? How 

can we do this in a proactive, efficient, and streamlined 

way? Behind the scenes, we steer discussions, coordinate 

reviews, manage timelines, facilitate consensus, and harmo-

nize global teams, all while writing the document at hand. 

Leadership is an integral part of our medical writing lives.

 Imagine the following scenario: Debbie sits at her desk, a 

partially finished document on her monitor. Fingers on her 

keyboard, she hesitates, but not for loss for words. She knows 

how to write the report but faces a quandary that affects all 

medical writers: she is missing some team comments yet is 

tasked with meeting the timelines. The last conference call 

did not resolve as much as hoped and left her with no clear 

direction. Additionally, the data have been updated again. In 

this familiar scenario, leadership and efficiency are needed, 

and sometimes the best option is … YOU.

 In this article, we offer solutions to several scenarios like 

Debbie’s that are applicable to contract, in-house, and free-

lance medical writers alike. We share experiences from sea-

soned medical writers compiled through informal surveys 

and discussions with our peers and collectively provide real 

world ideas on how to lead without authority, exercise diplo-

macy to your advantage, and provide insight on time man-

agement and personal efficiency. We provide guidance on 

how you can implement these strategies and takeaways into 

your everyday practice, including being able to identify proj-

ect-, team-, and time-management solutions that will help 

you grow as a medical writer and exercise positive and effec-

tive influence within your medical writing projects.

Leading Without Authority
Leading without authority takes courage to establish your-

self as a knowledgeable leader, not only from a writing stand-

point but also in understanding all aspects of developing 

and completing medical writing projects. This approach 

also takes work in understanding disease states, indications, 

document-management processes, standard operating pro-

cedures, and templates, as well as the guidance and regula-

tions that drive our industry. Last, leading without authority 

requires empathy in order to put yourself in your team mem-

bers’ shoes and understand what is driving their decisions, 

all while being committed to the quality and realistic man-

agement of the document.

Scenario 1

Debbie just sent out the third version of “Draft 1” for team 

review. She receives an email that the team has changed direc-

tions (again). Debbie is asked to abandon the third draft, 

return to the first draft (with some content from the third 

draft), and provide a new fourth draft in the next 2 to 3 days. 

What action should she take?

Although frustrated, Debbie knows the document is con-

nected to a corporate goal. She also realizes it’s a good time 

to take a quick break to relax and do something she enjoys. 

Returning to her desk, she checks her availability and con-

tacts her supervisor about this unanticipated draft.

 Asking for support may be her best option, rather than 

taking everything on herself. Debbie can

• Put a meeting on the calendar with the authoring team  

to discuss any questions she may have regarding this  

new direction.

Katie Bates, PhD; Dwyn DeSilver, BS; Cathi Harmon, BS / Whitsell Innovations, Inc, Chapel Hill, NC

Leadership Behind the Scenes: A Backstage  
Approach to Effective Medical Writing

PRACTICAL MATTERS

*This article was presented in part as a poster at the AMWA 2019 Medical 

Writing & Communication Conference.



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

• Check to ensure she understands the agreement for the 

number of drafts and the timelines.

• Recommend writing that can be done by a team member or 

another medical writer.

• Ask for more writing time, when appropriate, or a reduction 

in team review times.

Scenario 2

Debbie is excited that a project is finally going through 

approval. She unexpectedly receives an email from team man-

agement questioning the document’s accuracy and expressing 

surprise at the 1 day approval turnaround. What good options 

does she have?

This individual reviewed the document a week before; how-

ever, Debbie knows the document must be approved by this 

individual. Although taken aback at this turn, Debbie under-

stands this person reviews many items per day, manages 6 

people, and attends numerous meetings. Does she remember 

last week?

 Debbie realizes that clarifying the issue is the best option. 

Debbie can

• Take a step back to consider her approach to the situation 

rather than sending a premature email.

• Use empathic, fact-based language, such as:

–“Your statistician was an integral part in reviewing and con-

firming the data analysis in the document; her input has 

been invaluable.”

– “My apologies; it was my understanding that you had pre-

viously reviewed the document and the approval step is 

typically only a formal step to approve the document in 

the system.”

• Include in her response that she is available by phone to dis-

cuss further, if needed.

• Inform the entire team that document approval may be 

delayed and provide a revised timeline if appropriate.

 To be successful in leading without authority, as the medi-

cal writer, you need to be prepared, be kind but firm, and know 

your stuff. Understand what is potentially driving the behav-

ior (eg, corporate goals, being caught out of the loop) but stay 

committed to the quality and realistic management of the 

document. Use empathic language to soften the defensive 

nature of a person, as this approach would allow your audience 

to remain open to the facts you are presenting. It’s not about 

being right or wrong. It’s about building a successful relation-

ship and demonstrating your value to the team.

Team Diplomacy
Team diplomacy involves seeking to gain the perspective of 

your team members and navigating conflicting opinions in 

such a way that everyone is pleased with the outcome. Being a 

diplomatic leader requires building trust and gaining respect, 

being willing to listen, communicating rather than dictating, 

and using questions to solicit ideas.

Scenario 3

Debbie is waiting on comments from the last team member. 

Time is running out, and she suspects that the response may 

come later than expected. What good options does she have?

Although not ideal, if the team member is not a primary 

reviewer, it may be possible to proceed without those com-

ments. Knowing her team member’s role is critical to this 

option. During the kick-off meeting or initial interactions with 

the team, Debbie should clarify the hierarchy and roles within 

the team.

 If this team member’s comments are essential, it may be 

necessary for Debbie to accommodate late comments. It is 

important that Debbie be mindful of work/life balance, how-

ever, while ensuring the document moves forward.

She could

• Call the reviewer to better understand when the comments 

will arrive. This not only ensures the reviewer is aware of the 

importance of their input but also will help Debbie to plan 

accordingly.

• Send another email but carbon copy someone that the team 

member is accountable to or respects.

• Draft the email and include language regarding the updates 

that only requires confirmation from the reviewer. This is 

frequently more straightforward than asking for revised  

text directly.

• Reiterate timelines and the urgent need for their response in 

addition to the consequences of a missed deadline.

• Be persistent; ask more than once.

To be successful in leading 

without authority, as the 

medical writer, you need 

to be prepared, be kind but 

firm, and know your stuff.

PRACTICAL MATTERS



      AMWA Journal / V36 N1 / 2021 / amwa.org    41

PRACTICAL MATTERS

Scenario 4

Debbie is not getting the answers she needs at comment resolu-

tion meetings. There is significant dissent among team members, 

with no resolution in sight. Furthermore, the team frequently 

reverses their decisions after the meetings. Is there hope?

To try to resolve this issue, Debbie could

• Ensure that the project stakeholders attend the comment-

resolution meetings to address unresolved issues. This 

requires that Debbie understands the team dynamic.

• Break down multiple comments to an overarching  

comment or question to help focus the team to a more  

concise discussion.

• Ask the question, “Does the team agree?” as a means to  

prevent unnecessary discussion.

• Take the discussion offline with the key team members. 

Occasionally, it may be helpful to request that key team 

members discuss internally with one individual assigned to 

inform Debbie of any decisions.

• Be sensitive to cultural differences. Some team members 

may not directly contradict a team member in a meeting but 

may share information more readily with Debbie privately.

 Credibility is built on effective communication with your 

team. Whether you need to “tease out” comments from a 

reviewer or obtain team consensus, thinking creatively about 

how to best communicate and build rapport with individual 

team members while maintaining your boundaries is neces-

sary to ensure your effectiveness.

Personal Efficiency
Time management and personal efficiency are on everyone’s 

mind, with buzz words like “productivity hacks” all over the 

internet. In our world, carving out these efficiencies is essen-

tial for our medical writing work, because time translates into 

money. This can take the form of targeted best practices for 

document management to understand and capitalize on per-

sonal preferences, work habits, and discipline.

Scenario 5

Debbie receives unconsolidated review comments from the 

team, at different times and in different formats, and some 

are past the deadline. What is the most efficient approach for 

Debbie to deal with this?

Debbie can

• Understand the make-up of the team and their individual 

level of contribution to the progress of the document.

• Triage incoming comments by complexity and priority—

work on those requiring follow-up first, which allows  

progress while simpler comments are reconciled and 

incorporated.

• Keep a master document. As comments are triaged, incorpo-

rate revisions likely to be essential, and make notes of those 

that need team confirmation.

• Mark text or comments to be discussed with the team with 

an easily searchable symbol (eg, $$).

• Leave global changes until the end, keeping an ongoing list 

of global changes within the document to make after other 

comments are reconciled.

• Send relevant sections of the document (with specific ques-

tions and instructions) to targeted reviewers for quick and 

critical input.

• Maintain version control—this is essential. Devise a naming 

convention that captures the chronology and source of  

comments.

• Communicate! One set of consolidated comments for each 

draft is typically expected.

• Proactively assess the effect on timelines and anticipate 

delays.

Scenario 6

Debbie contemplates how to proceed given missing review com-

ments for her clinical study report and an unexpected data 

update. Other project timelines have now overlapped because of 

delays. Does she have too many balls in the air?

Debbie must

• Get organized with a spreadsheet across all projects—this is 

worth the time investment.

• Reel in the chaos by prioritizing what she can do and identi-

fying where she might need help.

• Delegate! It is essential, however, to provide appropriate 

training to anyone helping out, with thorough instructions 

and realistic expectations.

• Parse out blocks of time to work uninterruptedly on one 

task—darting back and forth is less efficient. Specific goals 

for these blocks of time is helpful.

• Eliminate distractions—Debbie can respond to urgent emails 

at designated times, then turn off her email and phone.

• Capitalize on when she works best and stick to it—this is 

important.

• Remind contributors of the consequences of continued 

delays for critical path issues.

• Ask for a summary of changes for data updates to help focus 

revisions.

• Take advantage of collective insight through AMWA online 

resources and the Engage forum. She is not alone!



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

 Leadership qualities such as being proactive and confident can 
make a world of difference in how you approach challenging tasks 
and situations. This can translate into time savings and efficiency 
in all aspects of a medical writing project. From knowing how to 
anticipate when you need help to interacting with difficult team 
members who are unable to review in a timely manner, confidence 
can ultimately help you get the job done.

Conclusion
Being a medical writer is a wonderfully rewarding career and 
always keeps you on your toes. Every team and project are differ-
ent, not to mention the constant change that goes with writing 
drug and device documents. Asserting behind-the-scenes leader-
ship is often critical to the successful conclusion of a writing proj-
ect, which in turn builds your team’s confidence in you as a writer 
and valued team member. Being able to communicate effectively 
and diplomatically is essential in developing successful relation-
ships with your teams. Although this profession can be demand-
ing at times, developing strategies that make you more efficient is 
key. In the end, sometimes the best option is how you personally 

approach each challenge. Sometimes the best option is you!

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

Author contacts: katie.bates@whitsellinnovations.com, dwyn.desilver@
whitsellinnovations.com, cathi.harmon@whitsellinnovations.com

Join our 
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The right candidates can be
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mailto:katie.bates@whitsellinnovations.com
mailto:cathi.harmon@whitsellinnovations.com
https://www.certara.com/company/careers
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