Director, Medical Writing

Kiniksa Pharmaceuticals · Lexington, MA

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Role summary

Kiniksa Pharmaceuticals seeks an experienced Director of Medical Writing to lead clinical document development and strategy for its growing portfolio of therapies. This senior individual contributor role focuses on creating scientifically rigorous narratives for clinical studies while advancing the medical writing function's quality and efficiency standards.

What they're looking for

Extensive experience authoring clinical study reports, protocols, and regulatory documents
Demonstrated expertise translating complex clinical and statistical data into clear narratives
Strong cross-functional collaboration skills with clinical, biostatistics, and safety teams
Advanced degree in life sciences or healthcare-related field
Deep knowledge of clinical development processes and regulatory requirements

What you'll be doing

Lead planning, authoring, and review of clinical study reports, protocols, and investigator's brochures
Ensure all documents meet standards for clarity, accuracy, consistency, and scientific rigor
Partner with Clinical Development, Biostatistics, and Safety to align messaging and facilitate efficient reviews
Contribute to medical writing function strategy and development of templates, tools, and best practices
Drive initiatives improving document quality, delivery speed, and cross-program messaging alignment

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