Writing a document around the clock across time zones
A writing team spread across time zones can keep a document moving through all twenty-four hours, either by handing the work from each writer's working day to the next or by drafting sections in parallel under continuous quality control. Whether it works depends on planning, the lead, shared tools and conventions, and how the project is run.
Working round the clock
Working across time zones as part of a multinational team can sometimes speed up the medical writing process. For example, if colleagues in the UK work on a manuscript during their business hours and send the version at the end of their day, it is morning in Australia, where a writer can continue editing during Australian business hours before sending it back. The client thus effectively gains almost 24 hours straight of medical writing time, and the whole process becomes more efficient. A project can be built around the clock, with colleagues in different time zones contributing during their respective days, creating a true 24-hour working day. By 2013, for a writer at a global contract research organisation who worked every day with colleagues in different time zones, a team strategically based in different regions so that it could work round the clock had gone from a far-fetched idea to almost reality.
Parallel authoring with continuous quality control
Sequential cycles of authoring and review have evolved toward a more collaborative, asynchronous process, which can take advantage of the time zone differences of a global or widely distributed team to make the most of development timelines. Collaborative writing allows authors to work on different sections while writers run continuous quality control checks. Across several time zones such writing can essentially continue around the clock, and in many cases it may be the only way to meet an aggressive timeline. Successful collaboration requires effective communication, clear expectations, careful planning and trust that each member will finish their tasks on time and to quality. Done well, collaborative writing helps build stronger team bonds, as remote colleagues become more aware of each other's cultures, working styles, native languages and personalities. Collaborative writing has its challenges, but collaborative authoring tools used effectively can enable it in ways that would otherwise be impossible.
Collaborating authors commonly have conflicting approaches to the work or to presenting ideas, and they must approach these differences collaboratively, with a problem-solving mindset. Flexibility is the key to collaborative, asynchronous document development: each writer should be available to collaborators to resolve issues and keep the work progressing, and sharing knowledge across the team, rather than dividing authors into silos, helps solve complex problems and enrich content.
The follow-the-sun relay
The "24/7 Follow the Sun" model is a global medical writing model for a team of writers, quality control reviewers and document specialists. Its developers report that it allows high-quality documents to be developed efficiently and in appreciably less time.
Time, quality and accuracy are of the essence for expeditious global regulatory submissions, and medical writers are perpetually asked to meet increasingly aggressive deadlines, for stand-alone documents and for parts of global submissions alike. The eight-hour day is often not enough, and working with subject matter experts in other time zones can make the shortfall worse. Compressed timelines raise the potential for error, add unplanned review cycles, stress the writers and can lead to missed corporate goals. Twenty-four-hour shift schedules have been used successfully in other industries but, as far as the model's developers knew in 2024, not in medical writing. The model was designed for continuous authoring and collaboration across the globe while keeping the team's working hours normal. Its goals are fewer days to develop a document, which reduces resourcing costs and the down-time lost to non-working hours and holidays; more efficient development through talent in several regions; and professional growth and a better work-life balance for the team. The model has been used for the clinical modules of a Common Technical Document submission, and its developers hold that it can be applied to other time-sensitive documents with diverse contributors and stakeholders, such as risk management plans or protocols.
In the relay, each member completes an agreed set of tasks in their working day and hands the work to the colleagues whose working day comes next, so the document progresses without interruption. When timelines are particularly aggressive, writers in overlapping time zones, such as Europe between India and the United States, can play a critical role in making the best use of the team's resources. The relay also makes continuous "rolling" quality checks possible as the document develops, and authors can focus on messaging and content with confidence.
Planning, team and lead
The project's scope should be set before it starts: its goals, writing deliverables, expectations, activities, tasks and timelines. The writing team should build a granular timeline of every writing task for the project, whether a single document or an interrelated set, which nests within the overall project timeline and against which the team tracks progress. The team should be chosen for experience in the tasks of document development, which include drafting content, creating in-text tables and figures, initiating peer, subject-expert and quality control review, resolving comments, proofreading and style-guide checks, and formatting. Balancing those skills against the timeline makes the best use of working hours across time zones, and members can be added or removed as the project's status demands, to keep support continuous. Careful planning in assigning each author a section promotes accountability and cooperation, and the writer's experience, background and personality are important to consider in that allocation.
A strong lead is essential. The writing lead, a role sometimes held by a project manager, coordinates all of the writing team's activities and should have excellent diplomatic and communication skills, the ability to see the big picture and the finer details, and a broad understanding of the project content, the strategic purpose of the documents and the deliverables. As the main interface with the wider interdisciplinary project team, the lead should attend its meetings, address, redirect or delegate the questions in the document that need team input, and manage the operational writing tasks. A clear management plan is needed, in which the lead must coordinate the supporting writers, direct questions to team members, keep the team informed of key decisions, identify critical updates and the sections they affect, and delegate tasks. The lead must also identify the action steps from start to finish, outline the tasks of document production and clearly define roles and responsibilities. Ideally the lead shares a time zone with the key project team members, and local sub-leads in each time zone, empowered to resolve issues and questions outside the lead's hours, can be valuable.
Shared tools and conventions
By 2022, increased demands and the collaboration across time zones they bring had made shared document platforms necessary and highlighted the importance of careful document hand-offs to "follow the sun".
A secure web-based workspace, such as Microsoft Teams, Vault RIM or SharePoint, lets the team store documents and work on them collaboratively and simultaneously. As a central repository it holds each document's current and previous versions with the resources for developing it: reference material, project timelines, team rosters, reviewer lists and team calendars. Files can be stored in shared repositories for retrieval at any time, and a common version control system and standard naming convention ensure that documents are saved appropriately. The tools used to draft must be accessible to every writer, including templates and toolbars with consistent predefined styles for text, headings, tables and references, and the styles can be preset in Word or as an integrated custom toolbar. A spreadsheet or Smartsheet that tracks the development plans, progress and action items ensures every deliverable is accounted for.
A conventions document is an important tool, covering project-specific matters beyond the sponsor's style manual. Drawn up before authoring, it lets the wider project team agree in advance on terminology (subject, patient or participant; trial or study), the content and structure of page headers and footers, standardised text such as treatment regimens and formulation descriptions, and the wording of key messages. It saves the team and reviewers time early on and reduces the risk from late-breaking requests and changes. It can also be used to identify and avoid terminology that may cause confusion when the content is translated into another language, and it is a living document that can be developed further as the product or project matures. One conventions document, for example, sets these rules:
- Write that adverse events were reported in x of y (x.x%) patients, not that a low incidence was observed, because with limited follow-up in phase 2 studies at the initial submission a word such as "low" may describe only the limited exposure.
- Write adverse events of special interest, not targeted adverse events, for consistency across the programme as agreed with the global safety function.
- Call an adverse event that occurred during study drug administration an infusion-related reaction, not an infusion reaction, and, unless it is specifically identified as an anaphylactic or immune-related reaction, refer to it as having occurred during drug administration.
- Give doses as treatment, dose, route and frequency, as in "drug 100 mg IV q8w", not "100 mg of drug administered intravenously every 8 weeks".
Communication and meetings
Effective communication is the most crucial success factor for a distributed team. The key is to balance real-time calls and instant messages, in which brainstorming is more effective, with offline work, which lets collaborators work autonomously, uninterruptedly and more productively, giving focused attention to each section. Proactive communication and responsiveness are key to building trust and collaborating successfully, and the writing team should agree on the quickest and easiest channel during development. Email is a useful global tool, and instant messaging such as Slack or Teams and comment bubbles in the document with @-mentions for targeted feedback can help. A colour code for highlighting text, developed for the relay, marks each passage's development stage, quality control status and need for attention:
- Green: a question for the team to address.
- Blue: text updated and needing further action by a writer, such as being ready for the lead's review, holding a question for the lead, or a writer's note to self.
- Yellow: text ready for quality control.
- Pink: text drafted and through quality control.
- Grey: text updated, reviewed by the lead, through quality control, and ready for team review.
Meetings of the writing team are vital for success. A pre-scheduled series, whose meetings can be cancelled when not needed, gives writers a time to ask questions and give updates, and regular meetings, sometimes daily, assess progress, encourage collaboration, identify action items and address problems. For less experienced writers, taking part and receiving real-time feedback from experienced writers is a growth opportunity that enhances skills and helps build and retain talent. Complex, high-visibility documents such as Module 2 summaries and briefing books are often assigned to senior writers, but junior writers have much to gain by contributing to them. A standing agenda encourages writers to come prepared with updates, and a tool such as OneNote can be used during the call to record status and decisions as an archive and to hold action items for follow-up. Timely, open feedback is essential to prevent errors, improve productivity, keep goals clear and boost the team's confidence.
The first pilot of the model was for a new biologics licence application that included four phase 1, two phase 1b/2 and two phase 3 studies. In it, minutes prepared after writing-team meetings and circulated by email took too much time, so they were replaced by live minute-taking in OneNote online. Meetings that went down the list of deliverables asking each writer for a status update also took too much time, so meetings instead asked whether anyone was behind the timeline and spent the time solving problems. A complex Excel tracker of granular tasks, instructions and assignments for each time zone was not maintained, and its inaccurate information created confusion, so the team relied instead on verbal communication at daily meetings, group instant messages, OneNote and, most importantly, communication inside the document through comment bubbles and the colour code.
Kick-off, authoring and close-out
With these elements in place, the follow-the-sun model can carry a single document, such as a clinical study report, or an interrelated set, such as the clinical overview, the Module 2 clinical summaries and a risk management plan. Work starts with a kick-off meeting for the whole writing team of writers, quality control reviewers and document specialists, guided by the writing lead and, as appropriate, line-function members. The meeting sets the tone and expectations and aligns everyone's understanding of the timeline, the deliverables and the key stakeholders. A typical agenda includes:
- Background material on the disease or indication, reference and source documents and journal articles, which a clinical or other expert can be invited to present.
- Confirmation of the project tools and templates.
- Assignment of roles, from the lead and any local sub-leads down to each writer's subjects or tasks.
- Agreement on the writing practices, such as lean writing, the conventions, template sentences for results, rolling quality control and its scope, such as no formatting or abbreviation checks, and standard email messages, so that the team writes with one voice.
The team then works rapidly and without pause across the time zones in its assigned roles: writing, inserting tables and figures, running rolling quality checks for accuracy and consistency, and applying formatting and style. The conventions document and the colour code help each writer see quickly what is needed and where, with consistent terminology, and writers add questions, assign tasks and give input through the agreed channels. Performance is best when responsibilities are very clear. Team members need to be willing to help each other as needed, as project needs may shift over time. Scheduled and ad hoc meetings allow rapid problem solving and can pivot resource allocation to unforeseen difficulties, such as ad hoc analyses, changes in strategy or re-run and updated tables. When a draft is available, reviewers can focus on content within their expertise, confident that the writing team has worked to identify and correct errors in data and formatting, which saves their time and energy. Section-by-section rolling quality control also shortens the final check near completion.
Once the deliverables have gone to the publishing team, everything used in developing them should be archived in the appropriate repository. Some or all documents may be needed later for regulatory inspections, questions from health authorities, journal publications or other communications about the product or programme. The now-experienced team is positioned to keep responding rapidly, saving time and resourcing energy when demands arrive. The team should then meet to discuss plus/delta experiences and outcomes, summarised as lessons learned for future projects, and key performance metrics should be summarised and compared with other projects to measure success or what still needs improving. This is also a time to commend individuals and teams for the work, and it may even spark a virtual global celebration. Being part of a successful team endeavour is invaluable for positive professional growth and a sense of self-worth, and the experience identifies and nurtures future leaders and encourages retention through a sense of belonging and accomplishment.
Benefits and challenges
According to its developers, the model:
- reduces stress and burnout by keeping writers to normal hours, and encourages best efforts for superior work
- creates a sustainable work-life balance that supports retention and job satisfaction
- engages talent through professional growth, international collaboration and challenging projects with highly skilled writers and subject experts
- solves problems collaboratively
- scales, so the team can be grown or shifted as work demands
- leaves the team with project knowledge that supports post-submission work such as agency responses
Its challenges are:
- building trust and rapport across cultures at the start, which takes time and effort from both sides
- managing time zones, vacations and holidays
- giving continuous open feedback, which takes time and effort
- keeping the central calendar current
- cultural differences in asking for help or clarification and giving feedback
- making documents read as if written by a single writer
- the difficulty some writers have with collaborative work, preferring ownership and control of a document
Results
The model's developers report that it was piloted successfully and then became business as usual for individual and interrelated documents in regulatory submissions, and they hold that it offers a sustainable, scalable answer to the ever-increasing need to develop high-quality documents faster. In the pilot, they report, time from draft to final was appreciably reduced by working across time zones with informed, engaged team members. As the model has been refined, its developers report, its benefits have included a significant reduction in time from data to final document, lower external resource spend, better collaboration among writers and subject experts, reduced reviewer workload and streamlined publishing. They add that opportunities for global collaboration, professional growth and better work-life balance give writers more job satisfaction and a greater sense of empowerment, which encourages talent development and retention, and the model has built lasting working relationships between teams in different regions. Building the model takes commitment from the whole team, its leaders and the key stakeholders. Its benefits can be significant, and success needs attention to individual and team needs at personal and corporate levels. The model predates ChatGPT and other generative AI tools and could be modified to incorporate them. In the developers' experience, the best results come from proactive planning, alignment of content and messaging, strategic assignment of tasks to suitable talent, and a culture of open communication founded on trust and mutual respect.