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

AMWAJournal.org     38

ABSTRACT
This article will discuss the real-world application of agile 

project strategies to expedite the development of high-quality 

deliverables that satisfy the structure and rigor of the regula-

tory environment. The coronavirus disease 2019 (COVID-19) 

pandemic challenged regulatory writers not just to rethink 

the structure of their workdays and the nature of their inter-

actions with their colleagues but to leverage technology and 

adopt strategic project thinking to help their teams meet 

aggressive timelines while working in the virtual workspace. 

Scenarios will include the application of agile project strate-

gies to working on COVID-19 programs or programs heavily 

impacted by COVID-19, from expedited submission pro-

cesses to rapid responses to regulatory authority requests 

for information. This assessment will include what strategies 

worked well, what strategies did not, and what an agile proj-

ect should look like within the regulatory writing space.

Across industries, different methodologies for project man-

agement are used. The most popular include the waterfall, 

Kanban, adaptive project framework, lean, and critical path 

methodologies.1 The reason for the variety in project man-

agement styles is simple—optimal delivery of a product in 

any industry requires processing of multiple intrinsic and 

extrinsic variables. In our experience in the biotech and 

pharmaceutical space, most regulatory writing deliverables 

have been planned by using the waterfall methodology; but 

the current space has become more dynamic, influenced 

almost daily by decisions made by regulators, research com-

mittees, health care professionals, venture capitalists, and—

most importantly—the scientific method itself. Delivering 

quality regulatory documents in the current space requires 

methodology adaptation to an evolving landscape. As the 

discipline of project management in other industries has 

evolved to account for ever-increasing change, with proj-

ect lifecycles now ranging from the very plan-driven to the 

iterative to the highly adaptive,1 the authors considered 

whether non-waterfall methodologies could be adapted to 

regulatory writing.

 This article briefly describes the waterfall approach his-

torically used in medical writing and discusses the appli-

cation of alternative project management methodologies 

to achieve quick, adaptive, and controlled regulatory docu-

ment development.

THE WATERFALL APPROACH AND ITS PITFALLS
Regulatory writing project management typically has fol-

lowed the waterfall method, which aligns with document 

development in an environment requiring sponsors to 

implement and maintain quality systems. The standard 

operating procedures (SOPs) that underpin these systems 

are often prescriptive, delineating steps that can be docu-

mented, thereby demonstrating compliance. Project time-

lines tend to mirror these SOPs in their fixed, stepwise 

progression toward controlled content creation. Project 

management software uses predecessor/successor inputs 

to capture this progression and can leverage this infor-

mation to generate understandable outputs for coauthors 

and non–medical writing stakeholders. The benefits of the 

methodology include ample time for both the regulatory 

writer and coauthors to think, research, and then write and 

align reviewer comments and changes across the document 

before the next iteration.

 This project management methodology is ideal for proj-

ects with a predictable path.1 The format and content of 

nonpivotal clinical study reports (CSRs), annual investigator 

brochure updates, or developmental safety update reports 

(DSURs) are well described in the regulations, generally 

limiting stakeholder impact on document structure, and  

the timelines may be defined by regulation (eg, DSURs) or 

may be driven by fewer extrinsic factors (eg, a competitive 

landscape).

 Whereas the waterfall methodology relies on predict-

ability, the regulatory writing environment has changed 

dramatically since the pandemic began. Regulations regard-

ing coronavirus disease 2019 (COVID-19) and non–COVID-

19 studies, contract research organization (CRO) and site 

procedures, and sponsor priorities shifted to enable accel-

Jeanette M. Towles and Jason S. Casavant / Synterex Inc, Boston, MA

Agile Strategies in the Rigid Regulatory Environment

RESEARCH

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AMWAJournal.org     39Agile Strategies in the Rigid Regulatory Environment

erated clinical evaluation of diagnostic, therapeutic, and 

preventive products to address the pandemic. Regulatory 

writing projects have been initiated without an assessment 

of requirements (eg, initiation of a full protocol without iden-

tified study endpoints due to an evolving understanding 

of the clinical course of the disease), well-vetted concepts, 

or access to real-time investigator clinical observations.2 

Consequently, regulatory writers have been asked to coau-

thor in real time in a manner significantly divergent from the 

stepwise collaboration afforded by the traditional waterfall 

methodology. 

ALTERNATIVE PROJECT MANAGEMENT STRATEGIES
During the first half of 2021, our operational and executive 

teams reviewed opportunities for continuous improvement. 

We focused on several COVID-19–related regulatory writ-

ing projects because of a recent uptick in requests for sup-

porting projects with accelerated timelines and imperfectly 

defined parameters similar to what we had observed with 

COVID-19–related projects, leading us to wonder if a linear 

way of working might become a relic and if we might need 

to adapt all or part of our business model. The scenarios we 

selected for review included the following elements:

• Required multiple resources within the company (eg, 

regulatory writer and operations support).

• Required >50% resource utilization for the  

regulatory writer for a discrete period.

• Timelines did not follow a sequential pattern  

(ie, one or more authoring steps were concurrent), so 

the writer was unavailable for other projects.

• Coauthoring with the client was done by using collab-

orative technology.

 The selected projects had a timeline that was prospec-

tively created and/or maintained by the regulatory writer and 

that was available for resourcing manager review.

Scenario 1
At the time of project initiation, just shortly before the pan-

demic was declared, one could count on both  

hands the number of COVID-19–related studies in  

clinicaltrials.gov. The regulatory writer used relevant soft-

ware and searches of clinicaltrials.gov for recruiting COVID-

19 treatment studies to collect clinical intelligence and 

develop a protocol synopsis, which was then used to facili-

tate regulatory agency, CRO, and site interactions (Table 1).  

After receipt of Food and Drug Administration (FDA) feed-

back on the pre–investigational new drug application (IND) 

package and about 2 weeks before IND submission, the 

FDA issued guidance on COVID-19–related study con-

duct.3-5 Given that the protocol was nearly finalized, the 

team had to quickly interpret the guidance, implement 

any changes addressing conflicts with prior clinical intelli-

gence and an evolving standard of care, and confirm those 

changes with internal and external stakeholders (eg, con-

firm that the FDA’s oxygenation cutoff for disease severity 

matched the site’s cutoff).

 Traditional stepwise project management methodol-

ogies were recognized as being too rigid for this dynamic 

environment, so the team incorporated strategies used in 

more adaptive methodologies. Change was rapidly com-

municated through a phone tree and scheduled check-ins 

every other day, with ad hoc meetings called for specific 

topics or live edits. The core authoring team was limited to 

the regulatory writer, clinician, and clinical trial manager, 

Table 1. Scenario 1: Medium-Sized Pharmaceutical Company 
Filing an IND in a COVID-19–Related Indication

Type of Product Treatment (COVID-19)

Requirements File IND

Systems Teams, PleaseReview (sponsor owned)

Regulatory Writing 
Resources

External consultants (no established MW 
  department)

Timelines Pre-IND meeting request package  
3 weeks
IND (2 weeks from pre-IND feedback)

Stakeholders US regulators; later in the process,  
  global regulators
IRB/IEC
Internal team
Internal management
Study sites
External philanthropy groups (funding)
CRO

Regulatory  
Landscape

Guidance still being drafted, no guidance 
available on endpoints and objectives yet; 
heavy cross-referencing to an existing 
IND in another indication

Risks Proceeded with protocol and informed 
consent form writing at risk ahead of pre-
IND feedback to meet timelines; defer 
many of the details on testing and analysis 
to ancillary documents (eg, Pharmacy 
Manual) because details not available yet 
(EUA for diagnostics had occurred only a 
few weeks previously2)

Project  
Management 
Strategies

Communication phone tree
Stand-up meetings every other day 
  between work sprints
Resource layering for ancillary writing tasks
Small core team
Cloud-based authoring and review

COVID-19, coronavirus disease 2019; CRO, contract research organization; EUA, 
emergency use authorization; IEC, independent ethics committee; IND, investigation-
al new drug application; IRB, institutional review board; MW, medical writing.

http://www.amwajournal.org
http://clinicaltrials.gov
http://clinicaltrials.gov


AMWAJournal.org     40Agile Strategies in the Rigid Regulatory Environment

with supplemental members reviewing specific language in 

the protocol, which enabled efficient and focused authoring 

during short work sprints. All authoring was done in Teams, 

with access managed by a dedicated information technol-

ogy (IT) professional who was part of the phone tree. A reg-

ulatory writing operations associate supported the writer by 

formatting, locating references, and managing citations. The 

document underwent a single round of management review 

in PleaseReview, during which most of the reviewers used 

the software’s commenting feature to provide substantive 

feedback. The team vetted management comments together, 

and the core authors discussed any outstanding issues with 

their line management outside of the review and reported 

back the results of the conversation. Roundtables attended 

by all core and supplemental authors as well as the manage-

ment reviewers were used to efficiently align on resolution of 

any pending comments.

 Structured communication and cloud-based tools were 

leveraged by the small core team, enabling them to effi-

ciently respond to shifts in the regulatory landscape while 

also permitting team members to author, consult with 

management and subject matter experts, and achieve con-

sensus. The team successfully provided a quality deliver-

able during an uncertain time in drug development and 

advanced an important potential treatment for COVID-19.

Scenario 2
This project proceeded in the context of hyper-compressed 

timelines and the need to look at not only new interim data 

but also cumulative data (Table 2).

 While the CRO was pulling the marketing application 

documents together and facilitating the various reviews, 

full-time employees (FTEs) and consultants provided over-

sight and management of timelines and risks and facilitated 

interactions with multiple internal and external stakehold-

ers. Because of the time constraints on the project, live data 

reviews were employed, during which the CRO regula-

tory writer engaged directly with stakeholders early in the 

drafting process, allowing for real-time drafting, consensus 

building, and a reduction in draft cycles. The success of this 

approach was contingent upon the availability of the correct 

attendees and their endorsement of this adaptation over 

more traditional iterative authoring and review processes.

 Although Scenario 1 used a small core team with tar-

geted reviewers to achieve consensus, this scenario used 

a larger review team, which included team members and 

management, to increase functional alignment at approval, 

which worked in large part because of the team trust at all 

levels. In this scenario, the use of PleaseReview followed 

highly prescriptive SOPs that did not enable the internal reg-

ulatory writers and the consultants (who only had reviewer 

licenses) to review live copies of fundamentally relevant 

documents (eg, parallel review of in-development CSRs or 

summary modules and in-development clinical overview). 

The system was used for a stepwise review, comment rec-

onciliation, and closeout workflow. Although PleaseReview 

allows for the attachment of reference documents to the 

review, those documents were changing concurrently, ren-

dering this option ineffective. Ultimately, a system was 

needed to facilitate document finalization with the key sub-

ject matter experts after team review. An initial attempt to 

use SharePoint for this activity failed because of a lack of 

prospective access management as well as restrictions on 

the use of guest accounts (for external consultants and reg-

ulatory writers) for internal SharePoint sites; the writer and 

subject matter expert resolved outstanding issues via email.

Table 2. Scenario 2: Medium-Sized Pharmaceutical Company 
Filing a Marketing Application in a COVID-19–Related Indication

Type of Product Preventive (COVID-19)

Requirements File a marketing application

Systems Teams, PleaseReview (CRO owned), Veeva

Regulatory Writing 
Resources

CRO writers
Internal FTE
External consultants functioning as em-   
  bedded FSP (established MW department)

Timelines 12 weeks (changed to 8 weeks)—critical/
ASAP

Stakeholders Global regulators, including multiple US 
  bodies
IRB/IEC
Internal team
Internal management
Study sites
CRO

Regulatory  
Landscape

Rapidly evolving; constant feedback from 
multiple agencies and the need to resolve 
divergent feedback; prior EUA and global 
conditional approvals

Risks Competitive landscape is a significant 
  concern
Multiple overlapping documents to meet 
timeline
Sponsor exponential growth in a short 
timeframe

Project  
Management 
Strategies

Communication phone tree
Stand-up meetings every other day 
  between work sprints
Resource layering for ancillary writing tasks
Small core team
Cloud-based authoring and review

ASAP, as soon as possible; COVID-19, coronavirus disease 2019; CRO, contract 
research organization; EUA, emergency use authorization; FSP, full-service provider; 
FTE, full-time employee; IEC, independent ethics committee; IRB, institutional review 
board; MW, medical writing; SME, subject matter expert.

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AMWAJournal.org     41Agile Strategies in the Rigid Regulatory Environment

 As a lesson learned from other submissions on the same 

program and aligned with sprint-style project management 

methodologies, the regulatory writing team attended spe-

cific key meetings, communicating about the submission 

and permitting the team more time to complete action 

items. The sponsor’s Head of Medical Writing attended gen-

eral meetings and CRO meetings, and the external consul-

tants divided up CRO meetings and other internal meetings; 

all external consultants and CRO writers attended most doc-

ument roundtables and stand-up meetings. Those who did 

not attend could access meeting information via a Teams 

chat, email, or a OneNote summary.

 Overall, although there were observations for future pro-

cess improvement, the regulatory and quality requirements 

of this dynamic submission were met, and a submission was 

filed on time for approval of a groundbreaking regulatory 

document.

Scenario 3
The work for this early-phase protocol began as sites across 

the United States began restricting access because of infec-

tious disease procedures.2 The protocol for this critical 

disease had been finalized around the same time the first 

COVID-19 cases were reported in the United States, and the 

study was in start-up (Table 3). As COVID-19 cases began 

to rise globally, the sponsor’s concerns mounted regarding 

the likely impact on study enrollment as well as the ability 

to ensure proper safety follow-up if patients were enrolled. 

A protocol amendment was planned to allow for alternate 

assessments and to reduce the overall travel burden and 

the chance for COVID-19 exposure for the patient, with the 

amendment including home collection of samples, select 

phone visits, alternative media for patient-reported out-

comes and informed consent, and home nursing for safety 

assessments and drug accountability and dispensation (as 

a last resort due to high cost). Guidance from the FDA on 

the conduct of studies during COVID-19 was issued several 

weeks into protocol development and informed several key 

mitigations that were planned6; however, at the time the 

guidance was issued, the pandemic was evolving, and the 

agency determined that prior public participation for the 

guidance was not feasible or appropriate, so early guidance 

was open to some interpretation.7

 The core authoring team was limited to the regulatory 

writer, regulatory writing operations associate, clinician, 

clinical trial manager, regulatory strategist, program man-

ager, and drug supply/ Chemistry, Manufacturing, and 

Controls manager. Involvement of each function in this 

group assured that the protocol was updated efficiently and 

accurately as conversations progressed with the CRO and 

other vendors in daily, 1-hour, focused working meetings. 

Authoring was done in Teams, with access managed by 

an FTE on the core authoring team. The document under-

went a single round of management review using the spon-

sor-owned PleaseReview platform, with the regulatory 

writer initiating and managing the review. Similar to review-

ers in Scenario 1, reviewers in this scenario mostly utilized 

the commenting feature. The team vetted management 

comments together, and the core authors gained align-

ment with their line management outside of the review. All 

authors as well as the management reviewers attended the 

roundtables.

 By limiting the team to line-function representatives, 

employing regular meetings, and using authoring and 

review tools that promote transparency, the team effectively 

Table 3. Scenario 3: Medium-Sized Pharmaceutical Company 
Amending a Protocol in a Non–COVID-19 Indication During the 
COVID-19 Pandemic

Type of Product Treatment (non–COVID-19)

Requirements Team was tasked with finding a way to add 
necessary flexibility to the study due to the 
evolving COVID-19 closures in H1 2020

Systems Teams, PleaseReview (sponsor owned)

Regulatory Writing 
Resources

External consultants (no established MW 
department)

Timelines 2 weeks

Stakeholders Global regulators, including multiple US 
  bodies
IRB/IEC
Internal team
Internal management
Study sites
CRO

Regulatory  
Landscape

Guidance on the conduct of studies 
during COVID-19 newly issued; IND had 
been open for some time, with one other 
completed early-phase study

Risks Q&A on FDA guidance on the conduct 
of studies during COVID-19 issued and 
updated during amendment authoring; 
implementation required active discussion 
with CRO partners and subcontracted 
vendors to ensure proper description 
and execution; mitigations might not be 
successful and came with a high price tag; 
small company with limited resources

Project  
Management 
Strategies

Resource layering for ancillary writing tasks
Core authoring team representing each 
  function
Cloud-based authoring and review

COVID-19, coronavirus disease 2019; CRO, contract research organization; FDA, 
Food and Drug Administration; H, half (of the year); IEC, independent ethics commit-
tee; IND, investigational new drug application; IRB, institutional review board; MW, 
medical writing; Q&A, Questions & Answers.

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AMWAJournal.org     42Agile Strategies in the Rigid Regulatory Environment

used multiple minor draft sprints to implement information 

and gain consensus as it became available in between meet-

ings with stakeholders and partners. The project aligned 

with emerging regulatory guidance while mitigating the 

impact of COVID-19 on enrollment, study feasibility, and 

participant safety.

DISCUSSION
Each regulatory writing project has a unique budget and 

unique collaborators, timelines, risks, and gaps. The regula-

tory writer and regulatory project manager must discuss the 

linkages of a project with department and company goals 

and determine the project management principles to apply; 

gathering the project requirements should be a deliberate 

process even in the face of urgent issues or tight timelines.

 In consideration of the scenarios described in this  

article, we determined that the strategies that best  

balanced a controlled process with adaptability were derived 

from the agile project management method (Figure 1), par-

ticularly the scrum framework. This method, often used 

in software development, is employed when the “require-

ments,” or specifications the software needs to meet, change 

over time as a result of competitive intelligence or other 

factors; this method uses continuous planning to rapidly 

identify and implement change.8 In all 3 of our scenarios, 

microdrafts were produced in short bursts, or “sprints,” in 

between other milestones (eg, internal meetings, stake-

holder meetings), continuously delivering a work product 

informed by feedback at all stages (Figure 2). Early and  

frequent delivery of microdrafts maintains project  

momentum and reduces the overall amount of work 

being done later in the process as well as the potential 

that late-breaking information could jeopardize quality or 

Figure 1. Principles of agile project management.  
Source: Rigby et al.8

Figure 2. Waterfall 
compared with 
Agile methodology 
for document 
production. Adapted 
with permission from 
Kissflow.10

.

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AMWAJournal.org     43Agile Strategies in the Rigid Regulatory Environment

on-time delivery. Regulatory writers often leverage relation-

ships to deliver quality documents on time, but the commit-

ment in these scenarios to produce high-quality microdrafts 

required the authoring team to be in regular contact to 

self-regulate and agree on the tasks to be completed, check 

on progress, and course correct as needed. The focus on 

optimal technical quality and design in this method is 

inherently aligned with the rigor required for regulatory 

documentation as well as the need to position regulatory 

documentation for the intended audience, and the meth-

od’s approach to simplicity is also aligned with the latest 

“lean authoring” trends in regulatory writing.9

 Any methodology must be paired with the best tools, 

systems, and practices. Setting expectations for how the 

team will work together and outlining roles and responsibil-

ities, as well as scheduling regular checkpoints, were criti-

cal success factors in each scenario. In addition, proactively 

managing systems access and education as well as the avail-

ability of a dedicated IT business partner to triage technical 

issues led to a more efficient authoring experience in some 

of the scenarios, even in a remote environment. It is also 

worth noting that no system is perfect; informing reviewers 

of any system limitations may help avoid pitfalls (eg, spon-

sor’s SharePoint is only set up to retain a certain number of 

versions, or contractors may not have compatible versions 

of Microsoft Office for coauthoring). Lastly, archiving com-

ments and decisions produced within any system requires 

regulatory writer discipline and should follow best practices 

and sponsor procedures to ensure that the rigor of regula-

tory documentation is met.

 Project management software was critical to the  

success of each of these projects, but we also concluded that 

certain software features not often used by regulatory writers 

have become critical in assessing the available resource pool. 

For example, we had underutilized the project utilization fea-

ture to show the exact number of hours that a writer would 

be dedicated to a project within the start and stop dates for a 

task.11,12 As the pandemic progressed and project complexity 

increased, we implemented the software’s enterprise resourc-

ing function, thereby enabling automatic initial notifications 

of project plan updates in between regular checkpoints.  

 As a result of our analysis, we also invested in Power BI 

business intelligence software to visualize data from mul-

tiple enterprise applications, including project manage-

ment and customer relationship management software. 

Implementation of this analytical tool empowered our lead-

ership team to efficiently track resource allocation and other 

details, including funds remaining on work orders at both 

the client and contractor level.13

 Communication was paramount in the completion of 

each document in the scenarios. Although the teams came 

to different conclusions about meetings, they each decided 

proactively how often and how to interact. Setting such 

expectations up front in a project both increases the odds of 

the project’s technical success and manages the potential 

for over-accessibility and burnout. If the team cannot pull 

away from these digital tools because of an inundation of 

competing requests, they cannot get the work done. In one 

of these scenarios, the sponsor acknowledged that they his-

torically had this exact issue and successfully addressed the 

feedback by dividing and conquering meeting attendance. 

Thus, several of the principles within the agile method, 

including the preference for face-to-face interaction, main-

taining a sustainable pace, and permitting the team to pro-

duce the deliverable, need to be balanced.

 The limitations of this review are that the assessments 

were retrospective (as necessitated by the level of engage-

ment required during the pandemic to complete the above 

projects) and that the number of projects sampled was 

small. The types of projects sampled met specific crite-

ria, and any projects that meet some but not all criteria 

(eg, COVID-19 impact assessment for a CSR) may require 

a combination of strategies depending on the context. In 

addition, in Scenario 2, we were engaged as a resource late 

in the project planning phase and may have been able to 

influence the project management approach had we been 

involved earlier.

 As we further consider implementation of agile meth-

odology in whole or in part, we acknowledge that the agile 

method of project management assumes that the workers’ 

time is retained, mostly available, and free of other distrac-

tions to be able to pivot. Within regulatory writing depart-

ments, resources often cover multiple deliverables over 

multiple programs, so a shift to properly resource agile proj-

ects may lead to a higher overall departmental budget. The 

ability to potentially get to market sooner, however, may 

outweigh this burden. This concept also may not be repre-

sentative of the way that all regulatory writers want to work 

and in fact will work best when the team wants to rapidly 

innovate in a unique way8; commoditization of this way 

of working could increase the risk for burnout and cause 

workers to lose faith in the principles of prioritization, trust, 

teamwork, and problem-solving that are core to this proj-

ect management method. Furthermore, this method may 

require writers with a requisite level of experience to be able 

to pivot as needed. Considering that experienced writers 

represent a finite portion of the workforce and given that the 

demand for this style of working may increase, this could 

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AMWAJournal.org     44Agile Strategies in the Rigid Regulatory Environment

leave a large gap in the available resource pool that needs  

to be urgently addressed by leadership in the regulatory  

writing field.

Acknowledgement
Synterex would like to thank Fulcrum Therapeutics, 

Goldfinch Bio, and Moderna, Inc. for their support in writ-

ing this article.  

Editorial credit
Jordan Sedlacek, Synterex Inc. 

Author declaration and disclosures: Jeanette M. Towles and 
Jason S. Casavant receive funds from several biotech and phar-
maceutical companies for regulatory writing services.

Author contact: jtowles@synterex.com

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https://kissflow.com/project/agile/traditional-vs-agile-project-management/
https://support.microsoft.com/en-us/office/view-resource-workloads-and-availability-in-project-desktop-3ee16869-68ad-4e63-bcb3-278ae34f7459
https://support.microsoft.com/en-us/office/view-resource-workloads-and-availability-in-project-desktop-3ee16869-68ad-4e63-bcb3-278ae34f7459
https://support.microsoft.com/en-us/office/view-resource-workloads-and-availability-in-project-desktop-3ee16869-68ad-4e63-bcb3-278ae34f7459
https://support.microsoft.com/en-us/office/view-resource-workloads-and-availability-in-project-desktop-3ee16869-68ad-4e63-bcb3-278ae34f7459
https://docs.microsoft.com/en-us/office/troubleshoot/project/calculate-work-duration-assignment
https://docs.microsoft.com/en-us/office/troubleshoot/project/calculate-work-duration-assignment
https://docs.microsoft.com/en-us/power-bi/connect-data/service-connect-to-project-online
https://docs.microsoft.com/en-us/power-bi/connect-data/service-connect-to-project-online
https://docs.microsoft.com/en-us/power-bi/connect-data/service-connect-to-project-online



