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Senior Manager, Medical Writer – Clinical and Regulatory
Cabaletta Bio. Plan, author, and finalize clinical and regulatory documents supporting Cabaletta Bio’s development programs .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in authoring and managing clinical and regulatory documents for cell and gene therapy programs, ensuring compliance with ICH standards and regulatory requirements. Proficient in mentoring and guiding teams in technical writing best practices while maintaining high-quality documentation standards.
Highest-signal resume keywords
Clinical And Regulatory Document AuthoringRegulatory Submission ExperienceTechnical Writing SkillsVeeva Vault ManagementBiotech Industry Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Technical WritingRegulatory SubmissionsQuality ControlDocument ManagementClinical ResearchBiostatisticsStudy DesignMedical TerminologySOP AuthoringData Analysis
Soft Skills
Attention To DetailCommunication SkillsMentoringProblem-SolvingProject Management
Tools & Technologies
Microsoft WordMicrosoft ExcelAdobe ProVeeva Vault
Industry Keywords
Cell And Gene TherapyINDBLAIMPDNDAMAAICH StandardsPharmaceutical RegulationsBiologics DevelopmentClinical Study Reports
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Plan, author, and finalize clinical and regulatory documents supporting Cabaletta Bio’s development programs
- Author 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
- Keep team members informed of review expectations and milestones
- Perform quality control and editorial review for accuracy, consistency, structure, and clarity
- Prepare documents for submission, including publishing readiness, quality checks, and finalization of supporting literature
- Maintain high-quality and efficient technical documentation supporting regulatory filings
- Mentor junior medical writers and subject matter experts on technical writing skills and best practices
- Participate in project team meetings and provide proactive solutions and advice
- Complete training on company document management systems
- Author or review clinical and regulatory departmental SOPs as needed
- Report to the Senior Director, Clinical and Regulatory Medical Writing
- Partner with Clinical, Biostatistics, Quality, and Regulatory teams to meet US, EU, and ICH standards
Requirements
What you’ll need- Bachelor’s or master’s degree in biological sciences with 6 years’ experience or Ph.D. with 2 years’ experience in a technical writing capacity
- Familiarity with key requirements for regulatory submissions in ICH regions and applicable pharmaceutical/biologics regulations and guidelines
- Experience reviewing and writing regulatory submission documents for global filings such as IMPD, INDs, MAAs, NDAs, and BLAs is preferred
- Ability to critically analyze, synthesize, and present complex information in well-constructed documents
- Working knowledge of drug/biologics development, clinical research, study design, biostatistics, regulatory environment, and medical terminology
- Confidence presenting to management, peers, and scientific or business collaborators
- Ability to support multiple projects and prioritize work independently
- Ability to comply with company and/or industry style guides and templates
- Ability to guide and train others in technical documentation writing
- Fluent written and spoken English
- Excellent attention to detail in consistency, grammar, syntax, and scientific accuracy
- Advanced skills in Microsoft Word, Excel, and Adobe Pro
- Experience in the biotech industry or startup industrial setting is preferred
Benefits
Comp & perks- Competitive benefits
- PTO
- Stock option plans
- Commitment to employee well-being and continuous growth
- Training and development opportunities