Medical Writer Quality Control Manager

Job Summary

Reporting to the Senior Director of Clinical Medical Writing, the full-time remote Manager, Medical Writer Quality Control will oversee the production of high-quality clinical and regulatory documentation, manage document preparation timelines, and ensure compliance with regulatory requirements for cell and gene therapy programs.

Key responsibilities:

• Assists in writing and generating clinical documentation and regulatory designations for cell and gene therapy programs
• Manages document preparation timelines and communicates with team members to ensure timely reviews and deliverables
• Reviews and edits documents authored by others, ensuring finalization for submission and compliance with quality standards

Required qualifications:

• Bachelor's or master's degree in biological sciences with 6 years of experience, or a Ph.D. with 2 years of experience in technical writing
• Familiarity with regulatory submission requirements in ICH regions and experience with global regulatory filings preferred
• Ability to critically analyze and present complex information in well-constructed documents
• Working knowledge of drug/biologics development, clinical research, and regulatory environments
• Advanced skills in MS Word, Excel, and Adobe Pro