In regulatory submission writing, a project facilitator is the yin to a medical writer’s yang

Abstract

Authoring and reviewing complex, parallel regulatory submission documents under extremely condensed timelines demands significant effort from the medical writing team. However, a skilled project facilitator can alleviate some of this burden by offering support and assistance across the entire spectrum of regulatory submission writing activities. This symbiotic partnership not only reduces the overall workload for the medical writing team but also enables them to focus on their core writing tasks, ultimately enhancing the quality of their work and reducing stress. Additionally, it provides an avenue for the project facilitator to establish standard ways of working and best practices, which can further enhance efficiency and consistency across multiple submissions.