Senior Manager Medical Writer, Clinical and Regulatory

About the role

Cabaletta Bio is recruiting a Senior Manager Medical Writer for its Clinical and Regulatory Medical Writing function in Philadelphia, PA. Reporting to the Senior Director, Clinical and Regulatory Medical Writing, you will plan, author and finalize clinical and regulatory documents supporting the company's development programs, working with Clinical, Biostatistics, Quality and Regulatory teams so documents meet US, EU and ICH standards.

Key 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.
• Perform quality control and editorial review to ensure accuracy, consistency, structure and clarity.
• Prepare documents for submission, including publishing readiness and quality checks.
• 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.

Required profile

• Bachelor's or master's degree in biological sciences, with 6 years' experience, or a Ph.D. with 2 years' experience in technical writing.
• Familiarity with regulatory submission requirements for pharmaceuticals and biologics in ICH regions.
• Preferred: experience reviewing and writing regulatory submission documents such as IMPD, INDs, MAAs, NDAs and BLAs.
• Preferred: biotech or startup industry experience.
• Fluent written and spoken English, with strong attention to detail, grammar, syntax and scientific accuracy.

Required skills

• Working knowledge of drug/biologics development, clinical research, study design, biostatistics, the regulatory environment and medical terminology.
• Advanced Microsoft Word, Excel and Adobe Pro skills.
• Ability to analyze, synthesize and present complex information, and to guide and train others in technical documentation.

What we offer

• Health and retirement benefits.
• PTO.
• Stock option plans.