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Medical Writing department heads from Bioforum and RRD International will discuss how to effectively select medical writing vendors and manage medical writing outsourcing.
With over 30 years of experience leading regulatory medical writing groups in the drug/biologic development industry, this will be a frank exchange of ideas and practical advice from both sides of the client/vendor relationship.
Agenda
- When is the best time to start looking for a MW vendor?
- Advantages and disadvantages of choosing a freelance writer compared to a medical writing company
- Important questions to ask during the vendor qualification stage
- The important is experience in a particular therapeutic area for a medical writing vendor
- The impact of geographical location of the medical writer on the project
PhD, Senior VP, Medical Writing, Bioforum The Data Masters
Shiri holds a PhD in cell, molecular and developmental biology from Tufts University, USA. She has been a medical writer since 2009. Shiri worked as a medical writer and medical writing team leader at Teva until 2014. Since then, she has been working as an independent instructor and consultant of medical writing. Shiri is experienced in managing medical writing projects of early and late phase product development. Her expertise encompasses study-specific documents such as protocols and clinical study reports, as well as development-program documents such as investigator’s brochures and summaries of efficacy and safety. Shiri is experienced in close collaboration with multi-disciplinary clinical development teams, specifically safety, biostatistics and data management aimed at producing the highest-quality, most regulation-compliant, clear and informative documents while adhering to timelines. In addition to regulatory documents, Shiri is an expert in writing scientific journal articles. She writes and edits manuscripts, and teaches workshops to medical doctors and scientists on this subject. Her book on the subject has recently been published worldwide.
MA, Senior Director, Medical Writing, RRD International
Ms. Burnett has more than 30 years of experience in the drug development/ contract research organization industry, primarily in the preparation and management of clinical and regulatory documents for FDA submission. Ms. Burnett is the Senior Director, Medical Writing at RRD International, LLC. She is responsible for overseeing the medical writing activities at RRD, including writing, document review, quality control, and management and training of in house writers and writing contractors. Prior to RRD she held the title of Director, Medical Writing at Quintiles Inc., and before that held positions in medical writing and clinical research at BRI International. Ms. Burnett has broad experience in multiple therapeutic areas. She has extensive FDA submission experience from the pre-IND stage through marketing applications. Ms. Burnett received an MA in English from George Mason University and a BA in English with a pre-medical track from Vassar College.
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