Suzanne Carlson

About Suzanne Carlson

Experienced contract medical writer and editor with almost 20 years in the biotechnology…

Experience

1. Medical Writer

   Kateric

   Feb 2013 — Present

   Professional regulatory documentation consultant providing medical writing, editing, and QC review services to a diverse range of clients. As a medical editor, responsibilities include adherence to client-specific templates/style guides as well as comprehensive document review to ensure proper grammar and internal consistency. Deliverables include but are not limited to: protocols, statistical analysis plans, Investigator Brochure’s, and Informed Consent Forms (ICFs). Medical writing deliverables include: • Development Safety Update Reports (DSURs): principal author and team lead ensuring compliance and on-time delivery • Patient Safety Narratives: principal author responsible for writing and reviewing narratives across multiple therapeutic areas (e.g, oncology, infectious disease) • Clinical Study Reports (CSRs): principal author responsible for writing/reviewing (Phase 1-3) Training Coordinator: Protocol and DSUR SME responsible for generating training materials, training new medical editors/writers on client specific deliverables, mentoring for a minimum of 6 months, supporting and reviewing all deliverables performed by new medical editors/writers prior to submission to the client.