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Regulatory Submissions, Information, and Document Management Forum
Session 7 Track 2 - Touchdown! or Fumble? The Medical Writing-to-Publishing Handoff
- Associate Director, Program Management
- Transcelerate Biopharma Inc., United States
Proper planning and communication between medical writing and publishing can facilitate a clean handoff and minimize threats to the submission timeline. The handoff from medical writing to the publishing team is critical and often occurs at the “11th hour” of the overall submission timelines. Often, medical writing deliverables are on the critical path and compete with publishing directives for the medical writers’ attention. This session will detail common risks, risk mitigation, and establishing integrated workflows across functions. Presenters provide perspectives of a project manager, medical writer, and finally the publisher to cover the end-to-end process of submission documents.
Medical Writing Perspective
Natalie Herr, PhD
- Medical Writer, Consultant
- Whitsell Innovations, Inc., United States
Lead Writer Perspective
Dove Bunkin-Thomas, MS
- Head of Vendor Oversight and Resource Management for Global Regulaotry Affairs
- Amgen, United States
- Senior Manager, Regulatory Operations
- Impact Pharmaceutical Services, United States