Good Science vs. Bad Writing: Strategies for Building an Effective Scientific Writing Team

Writing is not an innate talent, but a learned skill requiring extensive training and practice. Scientific writing is no exception. As scientists, we have all seen examples of how bad writing and ineffective communication can detract from good science. The goal of this presentation is to describe strategies to support effective partnerships between regulatory experts and your writing team.
In this presentation, we will discuss what it takes to produce a document that is clear, concise, and complete, meeting basic regulatory requirements but also effectively telling the story of your device. We will also present strategies to help you assess your current writing processes and offer tips for document preparation to support effective writing partnerships within your organization. And finally, we will describe recent themes and feedback regarding medical device and in vitro device evaluation reports, as well as ways to proactively design solutions to common concerns including time, budget, bandwidth, and internal resources.
During this presentation, we will…
1) Discuss how to plan a realistic timeline for your project.
2) Provide advice for assessing your team’s bandwidth and scientific writing expertise.
3) Present examples of key documents and inputs needed early in the writing process.
4) Describe how Regulatory Affairs can support critical decision-making throughout the planning and preparation of these key reports.
5) Provide practical strategies to support successful completion of these writing projects with an outside writing partner.
Intended audience: Regulatory Team, Executives & Stakeholders