Principal Medical Writer

The Principal Medical Writer will be accountable for all clinical writing aspects of assigned clinical trials and projects, authoring robust reports, summaries, and regulatory documents with scientific rigor and quality. This includes device and/or pharma CSRs, plain language summaries, submission modules, and investigator brochures. The role involves representing Clinical Writing on Clinical Trial Teams, reviewing protocols and TFL shells, and managing the authoring, review, and approval of investigator brochures. The writer is responsible for the accuracy of content, implementation of best practices, training new writers, providing feedback on templates, identifying trends to improve quality, defining outsourcing specifications, and contributing to clinical sections of regulatory documents. They will also write and edit pre-clinical and/or clinical reports, ensuring timely development of documents for regulatory submission and providing recommendations for documentation formats and guidelines.