Victoria Butler
Associate Director, Medical Writing (Inflammation and Immunology) @Apogee Therapeutics
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WORK HISTORY
Associate Director, Medical Writing (Inflammation and Immunology) @Apogee Therapeutics
San Diego, CA, US
EDUCATION
University of Cambridge
Bachelor’s Degree, Neuroscience
University of Cambridge
Doctor of Philosophy (Ph.D.), Molecular Biology
ABOUT VICTORIA BUTLER
Medical Writer (Associate Director) working in Inflammation and Immunology at Apogee Therapeutics.Leading preparation of regulatory documents to support Phase 1-4 clinical development:• Protocols• CSRs• NDAs/MAAs (including Module 2 components that comply with the ICH eCTD structure - Clinical Overview, Summary of Clinical Efficacy, Summary of Clinical Safety, Post-marketing safety data)• Pediatric Investigation Plans/Pediatric Study Plans• Briefing Documents and Slide Sets for Health Authority MeetingsMedical Writing Experience with Accelerated Pathways:• FDA Emergency Use Authorization and Fast Track DeisgnationCreation of documents to support product development, license application and post-marketing maintenance.Provide project teams with expertise on analysis and presentation of clinical, safety and benefit-risk data, regulatory requirements and corporate policies governing documents for regulatory submissions.Drive document strategies and messages in a collaborative way with project team subject matter experts.Background• Neuroscience/Molecular Biology PhD with extensive experience in the design, execution and interpretation of Cellular and Behavioral research• Strong expertise in Writing Scientific/Academic Manuscripts, Grants, Abstracts, Design/Interpretation of Clinical Trials Data and Statistical Analysis• 12 peer-reviewed publications in High Impact Journals, including a Textbook Chapter published by Springer Protocols. • Peer-reviewed for Scientific Journals including Cell Reports and Human Molecular Genetics. • Presented more than 10 abstracts at Scientific Conferences and given Invited Talks at both the National and International level, including 3 Award-Winning Poster Presentations• Proficient at using Microsoft Office, Adobe Illustrator and GraphPad Prism• Strengths include written and oral communication, project management, protocol development, interactive teamwork and managing external collaborationsInternationally experienced having worked in the UK and east/west coasts of USA.British and US Citizenship.
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