Medical writing is an established core competency in the pharmaceutical industry providing a compelling value proposition with deep knowledge, skills, and experience. The demand for skilled medical writing professionals in Pharma and Healthcare continues to rise with the accelerated pace of drug development, enhanced regulatory and data transparency requirements, and innovation in digital communications. A career in medical writing presents diverse opportunities for scientific professionals to apply their scientific knowledge and writing expertise to translate clinical evidence into impactful and timely regulatory documents and peer-reviewed publications. We present an argument for why medical writing should be not just an alternative career, but a career of choice. The focus of this chat will be on 3 main areas of current interest for both Sponsors and Agencies: hiring in talented writers, training new and current writers and retaining top talent.
Session 3 Track 2: DSUR Best Practices: Empowering Medical Writers to Create ICH-compliant Development Safety Update Reports
Mari Welke |Director, Safety & Innovation
The Development Safety Update Report (DSUR) is a document written by medical writers; however, there are two distinct pathways required to develop an ICH-compliant DSUR – the process of gathering the information required and the task of compiling the information into the DSUR template. This session will address DSUR best practices for the medical writer to ensure a process is in place to drive the production of the deliverable. Common pitfalls, misconceptions and “tips and tricks” for writing the DSUR will be shared, with audience participation encouraged.
Session 5 Track 2: Lean Authoring and Global CTD Submission
David Meats |Associate Director, Regulatory Services Management
In this session, participants will learn the key tenets of the lean authoring methodology and process. In addition, attendees will learn how to apply these techniques to simplify and shorten the length of certain components of an eCTD submission. These taken in tandem can reduce the complexity, length, and potential for error.