Senior Manager Medical Writer, Clinical and Regulatory Medical Writing

Reporting to the Senior Director, Clinical and Regulatory Medical Writing, the Manager/Senior Manager Medical Writer is a key member of Regulatory Affairs. You will plan, author, and finalize clinical and regulatory documents that support Cabaletta Bio's development programs, ensuring they are clear, accurate, and strategically aligned. You will partner with cross-functional teams, including Clinical, Biostatistics, Quality, and Regulatory to ensure documents meet US, EU, and ICH standards. Responsibilities: Author clinical and regulatory documents for cell and gene therapy programs, including INDs, Module 2 documents supporting BLAs, protocols and amendments, investigator brochures, and clinical study reports. Manage document timelines and review workflows in Veeva Vault, keeping team members informed of expectations and milestones to ensure timely reviews and approvals. Perform quality control and editorial review to ensure documents meet standards for accuracy, consistency, structure, and clarity. Prepare documents for submission, including publishing readiness, quality checks, and finalization of supporting literature. Maintain high quality and efficiency in technical documentation that supports regulatory filings. Mentor junior medical writers and subject matter experts on technical writing skills and best practices. Participate in project team meetings and offer proactive solutions and advice. Complete training on company document management systems, and author or review departmental (clinical and regulatory) SOPs as needed. Perform other duties as assigned. Qualifications: