Job Duties: Collaborates with cross-functional teams to prepare, review, and edit high-quality, scientifically accurate, and submission-ready documents including, but not limited to: clinical protocols, Investigator's Brochures, Clinical Study Reports, Regulatory briefing documents, Module 2 summary documents, and other clinical and regulatory documents. Familiarity with AI tools and the ability to use them in a compliant and responsible manner, including validating outputs, mitigating risks, actively reinforcing responsible use across teams, and ensuring strict adherence to company policies and regulatory requirements.