An important submission was planned but there was insufficient experienced in-house writing resource.
Our task was to author the clinical overview, clinical summaries, pivotal Phase III report including narratives, and supporting study reports.
One lead writer acted as project manager to facilitate communication and to respond to changes in submission planning. Three senior writers were assigned to lead development of key documents. Four support writers assisted with quality control, straightforward document tasks, and narrative preparation.
A successful submission was completed on time. Document development plans were modified during the process to manage unexpected issues.