Working with a project facilitator on a submission
A project facilitator takes some of the logistical load of a regulatory submission off the medical writing team so that the lead writers can concentrate on the writing. The facilitator works beside the writers through every phase without authoring, and the role rests on six activities.
What the lead writer carries besides the writing
Authoring and reviewing complex, parallel regulatory submission documents under extremely condensed timelines demands significant effort from the medical writing team. Over the last 20 years the lead medical writer's role has become ever more complex, developing far beyond writing itself. Activities that must be kept up besides drafting, reviewing and revising the Module 2 summaries for a regulatory submission include:
- A project plan must be created and maintained to keep track of the numerous interdependencies.
- Writing resources must be juggled to handle additional writing activities, for example owing to new analyses, sometimes even new studies, and supporting reports.
- Subject matter experts must be corralled, in the face of many competing priorities, to agree on content.
- Messaging plans must be developed and kept up to date as new ideas arise.
- Any quality control activities must be planned, performed and implemented in the documents.
Monitoring these activities can consume a substantial portion of the writer's time, diverting attention from the core responsibility of producing high-quality documents.
What a facilitator offers the writing team
A role has evolved to take some of these responsibilities off the medical writer so that the writer can concentrate on the writing itself, and two practitioners term this specific branch of project management, designed to support medical writers on complex projects, project facilitators. The relief holds particularly in crunch periods, when new data are arriving and the writer needs to be focused on conversations with the subject matter experts to tease out the story to be told. A skilled project facilitator can relieve some of the writing team's burden by supporting the whole spectrum of regulatory submission writing activities. This symbiotic partnership reduces the team's overall workload and lets the writers focus on their core task of writing, enhancing the quality of their work and reducing stress. In one editor's view, the facilitator's ability to navigate the complex web of requirements and streamline the submission process is often indispensable for medical writing teams operating under extreme time constraints. A competent and seasoned project facilitator can make all the difference to how efficiently a regulatory submission is prepared and to getting it done on schedule.
The addition of a facilitator's skillset to medical writing activities can help teams achieve maximum effectiveness, and the facilitator's ability to engage stakeholders early in the submission process, manage priorities, build consensus and create an environment that embraces change has a profound impact on team effectiveness. As projects have grown more complex, with more stakeholders involved, more regulations to consider and a general push to have drugs reach the patient sooner, the facilitator's contribution is a valuable addition to medical writing teams.
The facilitator's place in the team
The facilitator may serve as a central point of contact for logistical and overarching concerns among the medical writing team. While not directly involved in authoring documents, the facilitator actively participates in every phase of the project, including study start-up, authoring support, review monitoring, quality control, publishing and project close-out coordination. The role extends beyond mere coordination: the facilitator fosters unity among team members by developing trust, flexibility, cooperation and collaboration within the cross-functional team, and works in tandem with the lead medical writers as a partner to ensure nothing falls through the cracks. The facilitator helps the team make sure that projects are well defined, with clear objectives, timelines, budgets, resourcing and metrics, and that these are adhered to.
In regular communication with the medical writers on the project, the facilitator can help keep team members connected and can see tasks where the writers need a helping hand, such as setting up meetings or reaching out to team members for missing source material. The facilitator takes part in key meetings such as the kick-off meeting, which is a chance for the facilitator to get familiar with the team and determine the preferred communication methods and frequency. The facilitator may also use that time to set goals and priorities, working closely with the team early in planning to obtain its input on all major decisions. Through this process the facilitator gets to know the team and establishes the standard ways of working, and can note team dynamics, training or knowledge gaps, and mentoring opportunities for team members new to a submission. The partnership also gives the facilitator an avenue to establish standard ways of working and best practices that can further enhance efficiency and consistency across multiple submissions.
Skills the role demands
The role demands a solid understanding of all standard operating procedures, best practices and work instructions, and leadership skills that influence the interactions between the cross-functional team. It also demands a broad variety of other skills, including building interpersonal relationships, critical thinking, analytical abilities, budgeting, decision-making and problem-solving. As one leader in the pharmaceutical field explains, project facilitators can be likened to conductors leading an orchestra in which the project team are the musicians. Just as a conductor must know the entire score and anticipate the challenging parts, the facilitator needs to understand the whole project, recognise potential obstacles and work out ways to overcome them. Just as a conductor may improvise or modify a performance, the facilitator may need to help the team see when to adapt and adjust the project as it proceeds.
The six activities of the role
As submission projects get into full swing, they require constant and effective collaboration between the medical writers and a diverse, multidisciplinary team of clinical, statistical, regulatory, safety and other functional experts, and the project facilitator supports the writing team through six key activities.
Creating and maintaining the project timelines
Helping a team stay focused on timelines keeps the project on course. Throughout the authoring, review and approval periods, the facilitator monitors the progress of the timeline and, together with the writing team, flags up changes in scope that may shift it. The facilitator recognises deviations from the plan when the rest of the team may be focused on other things, and acts swiftly to develop contingency plans that bring the project back on track. The facilitator organises meetings between the writers and the key stakeholders to renegotiate the timeline and make decisions in a timely manner, and is often tasked with providing the revised timelines to the project team promptly.
Tracking the budget
A regular review of milestones in parallel with the budget can illuminate areas of low or high efficiency. The facilitator monitors the budget throughout the life of the project and assesses the impact on the budget of changes in scope, timelines or resourcing. If the required resources will cost more than anticipated, the facilitator discusses this with the relevant stakeholders and takes appropriate action, which may involve developing a revised cost plan.
Monitoring changes in resources
Active engagement helps teams achieve maximum effectiveness. The facilitator maintains a resourcing plan throughout the project that details each team member's roles and responsibilities. The facilitator proactively identifies and helps address resourcing bottlenecks resulting from competing priorities, mediating discussions within the writing team to balance workloads and prevent burnout. Where resources need adjusting, the facilitator may help the writers organise a thorough handover. Because medical writers often exceed a 40-hour workweek while managing several documents at once, a skilled facilitator's expertise is essential in coordinating resources.
Facilitating cross-functional communication
Clear communication is imperative for teams to thrive. The facilitator keeps several open lines of communication with the team, using formal check-in meetings and informal chats to keep every member informed about timelines, budgets, resources and pending deliverables. The facilitator organises reviews and comment resolution meetings and clarifies the timing and roles for each team member. Recognising everyone's time constraints, the facilitator ensures that individuals are involved appropriately in each step. The facilitator encourages teams to limit the number of reviewers per document and consolidate feedback into one set of comments per function, and can engage senior management to enforce these guidelines if necessary. As the project nears completion, the facilitator may help coordinate with the quality control and publishing teams, confirming timelines, deadlines and source document availability to relieve the medical writer.
Optimising the delivery of inputs and outputs
With a firm understanding of the interdependencies within a submission, the facilitator can help the writing team obtain all necessary inputs, such as literature, new analyses and review comments, from the subject matter experts on an ongoing basis. The facilitator also facilitates the timely delivery of drafts for review or approval and oversees progress to ensure deadlines are kept. Weekly check-in meetings provide a platform for the team to discuss these inputs and outputs together.
Assisting with risk management
A close examination of the issues and risks that affect productivity is the first step in troubleshooting and reaching resolutions. The facilitator invests time in identifying and understanding risks to the successful completion of the project. By monitoring all changes as the project evolves and working closely with the writing team to understand and meet its needs, the facilitator proactively addresses resourcing constraints, bottlenecks and other concerns as they arise. Any risks to the goal of a timely submission to a health authority need to be identified and mitigated. Working with the medical writers and the clinical and regulatory teams, the facilitator can help avoid or overcome them.
Lessons learned after a submission
The facilitator can also coordinate and run a lessons-learned meeting after a submission is complete, keeping a running tab of the issues that arise during the project as a starting point for discussion. Having monitored progress throughout, the facilitator is in a good position to recognise both efficient and problematic areas, and that perspective can help keep the conversation balanced. Emphasising positive aspects boosts team morale and engagement, and striking a balance between addressing issues and acknowledging successes fosters a collaborative and motivated team.