EFFECTIVE STRATEGIES FOR MEDICAL WRITING PROJECT MANAGEMENT

Medical writers are often responsible for authoring multiple regulatory documents simultaneously, but also serve as the project managers for each of those documents. Project management includes not only the management of documents, some of which can span over thousands of pages, but also the management of project teams from both nonclinical and clinical functions. The key to finalizing a quality document is based on how successful the Medical Writer operates as a project manager, navigating through the details and providing structure and guidance to the team along the away. Project management ultimately plays a key role in the timely finalization of a quality regulatory document. The following presentation will provide attendees with some effective strategies for managing medical writing documents and project teams from start to finish, focusing on:

• Organization prior to and during the document process
• Forecasting and managing the timeline
• Communication, when and how
• Planning and leading strategic meetings
• Initiating productive document reviews
• Consolidating and resolving review comments

Speaker:
Lynne Munno
Associate Director, Medical Writing
Deciphera Pharmaceuticals