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Creating structure and standards: Building the plane while you’re flying
Join industry experts Faruk Pasic, ELS, Medical Writing Operations Specialist, formerly of Takeda Pharmaceuticals and Abigail Shetler, ELS, Executive Director of Wordsmith Medical Writing LLC, for our on-demand medical and regulatory writing masterclass.
Faruk and Abigail discuss their experiences of pioneering change in medical writing departments. They share recommendations for setting up structure, standards and processes across a team (“building the plane”) while still meeting the needs of the business (“flying”) in the fast-paced and competitive industries of pharmaceuticals and biotechnology.
This webinar provides an engaging discussion on establishing effective workflows to streamline your document development and supporting operations processes.
Key takeaways:
- Discover how medical writers and other personnel can create or enhance structure, standards and processes across a team
- Gain recommendations for managing document development projects and supporting operations across a team
- Gain insight into increasing adherence to standards and compliance with processes
- Learn how to improve consistency and increase efficiency during the document development and review process
Faruk Pasic earned his Ph.D. in German Studies in 2013 and subsequently completed a one-year postdoctoral fellowship at Washington University in St. Louis.
His career started as a technical editor at Synchrogenix (now part of Certara), where he learned the skills that form the foundation of his regulatory writing career. Since this, Faruk worked as an independent contractor before taking a full-time role in the nonclinical writing and submissions group at Takeda Pharmaceuticals. He was responsible for QC of nonclinical reports and submission documents, editorial review of manuscripts and document management.
After four years at Takeda, Faruk recently took a position as Medical Writing Operations Manager at Vertex Pharmaceuticals.
Abigail Shetler is the Executive Director of Wordsmith Medical Writing LLC. Abigail entered the medical writing field approximately 10 years ago as an editorial intern for the biomedical research department of a hospital.
She is now a board-certified Editor in the Life Sciences (ELS) and American Medical Writers Association (AMWA) member with extensive experience in global submissions, such as regulatory, medical writing and quality control best practices. Abigail has led writing, quality control, publishing and submission activities for a variety of pharmaceutical/biotechnology companies and contract research organizations.
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