Director, Medical Writing
Kiniksa Pharmaceuticals
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.
Responsibilities
- 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
Requirements
- 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
Vacancy posted 5 days ago
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