Senior Manager, Medical Writer – Clinical and Regulatory

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Develop, write, and finalize clinical and regulatory documentation to support Cabaletta Bio’s development initiatives.

• Create documents for cell and gene therapy projects, including INDs, Module 2 documents for BLAs, protocols and their amendments, investigator brochures, and clinical study reports.

• Oversee document timelines and review processes within Veeva Vault.

• Keep team members updated on review expectations and key milestones.

• Conduct quality control and editorial reviews to ensure accuracy, consistency, structure, and clarity.

• Prepare documents for submission, which includes readiness for publishing, quality checks, and finalizing supporting materials.

• Maintain high standards of technical documentation to support regulatory submissions.

• Mentor junior medical writers and subject matter experts on best practices in technical writing.

• Engage in project team meetings, offering proactive solutions and advice.

• Complete training on the company’s document management systems.

• Author or review clinical and regulatory departmental SOPs as required.

• Report directly to the Senior Director of Clinical and Regulatory Medical Writing.

• Collaborate with Clinical, Biostatistics, Quality, and Regulatory teams to ensure compliance with US, EU, and ICH standards.

⛳️ Requirements

• Bachelor’s or master’s degree in biological sciences with 6 years of experience, or a Ph.D. with 2 years of experience in a technical writing role.

• Knowledge of key regulatory submission requirements in ICH regions and relevant pharmaceutical/biologics regulations and guidelines.

• Preferred experience in reviewing and writing regulatory submission documents for global filings such as IMPD, INDs, MAAs, NDAs, and BLAs.

• Capable of critically analyzing, synthesizing, and presenting complex information in well-organized documents.

• Proficient understanding of drug/biologics development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology.

• Confidence in presenting to management, peers, and scientific or business collaborators.

• Ability to manage multiple projects and prioritize tasks independently.

• Adherence to company and/or industry style guides and templates.

• Competence in guiding and training others in technical documentation writing.

• Fluent in written and spoken English.

• Exceptional attention to detail regarding consistency, grammar, syntax, and scientific accuracy.

• Advanced proficiency in Microsoft Word, Excel, and Adobe Pro.

• Preferred experience in the biotech industry or a startup environment.

🏝️ Benefits

• Competitive benefits package.

• Paid Time Off (PTO).

• Stock option plans.

• Commitment to employee well-being and continuous professional growth.

• Opportunities for training and development.