Manager, Medical Writer and Quality Control
Cabaletta Bio
August 06, 2026
Remote
United States
Clinical Research and Development
About The Position
Reporting to the Senior Director, Clinical Medical Writing, the Manager, Medical Writer Quality Control Specialist will manage and support regulatory/clinical documentation for cell and gene therapy programs, ensuring compliance with US, EU, and ICH requirements.
Responsibilities
- Assist with writing and generation of clinical documentation (protocols, investigator brochures, informed consents) and regulatory designations (e.g., orphan drug applications, fast track, RMAT)
- Manage document preparation timelines; communicate with stakeholders to support timely reviews and milestone delivery
- Review and edit documents authored by self and others
- Ensure documents are finalized for submission (publishing readiness, quality checks, supporting literature)
- Support clinical trial readiness with Clinical Ops and CROs (IRB/IBC communications/responses, study manuals, etc.)
- Maintain high quality/efficiency in technical documentation for regulatory filings
- Convert technical study data into regulatory reports
- Train and mentor SMEs on technical writing skills and best practices
- Participate in internal/external project team meetings; provide proactive solutions
- Train on document management systems; author and/or review departmental SOPs
- Perform other activities as assigned
Qualifications
- BS/MS in biological sciences; 6 years’ experience, or PhD with 2 years in technical writing
- Familiarity with ICH-region regulatory submission requirements
- Preferred: experience writing/reviewing global filings (IMPD, INDs, MAAs, NDAs, BLAs)
- Ability to analyze/synthesize/present complex information
- Working knowledge of drug/biologics development, clinical research, study design, biostatistics, regulatory environment, medical terminology
- Ability to present to management and collaborators; prioritize independently; follow style guides/templates
- Fluent English with strong attention to grammar, consistency, and scientific accuracy
- Advanced MS Word/Excel/Adobe Pro
- Preferred: biotech or startup environment experience
Reporting to the Senior Director, Clinical Medical Writing, the Manager, Medical Writer Quality Control Specialist will manage and support regulatory/clinical documentation for cell and gene therapy programs, ensuring compliance with US, EU, and ICH requirements.
Responsibilities
- Assist with writing and generation of clinical documentation (protocols, investigator brochures, informed consents) and regulatory designations (e.g., orphan drug applications, fast track, RMAT)
- Manage document preparation timelines; communicate with stakeholders to support timely reviews and milestone delivery
- Review and edit documents authored by self and others
- Ensure documents are finalized for submission (publishing readiness, quality checks, supporting literature)
- Support clinical trial readiness with Clinical Ops and CROs (IRB/IBC communications/responses, study manuals, etc.)
- Maintain high quality/efficiency in technical documentation for regulatory filings
- Convert technical study data into regulatory reports
- Train and mentor SMEs on technical writing skills and best practices
- Participate in internal/external project team meetings; provide proactive solutions
- Train on document management systems; author and/or review departmental SOPs
- Perform other activities as assigned
Qualifications
- BS/MS in biological sciences; 6 years’ experience, or PhD with 2 years in technical writing
- Familiarity with ICH-region regulatory submission requirements
- Preferred: experience writing/reviewing global filings (IMPD, INDs, MAAs, NDAs, BLAs)
- Ability to analyze/synthesize/present complex information
- Working knowledge of drug/biologics development, clinical research, study design, biostatistics, regulatory environment, medical terminology
- Ability to present to management and collaborators; prioritize independently; follow style guides/templates
- Fluent English with strong attention to grammar, consistency, and scientific accuracy
- Advanced MS Word/Excel/Adobe Pro
- Preferred: biotech or startup environment experience