Senior Manager Medical Writer

Job Summary

Reporting to the Senior Director of Clinical and Regulatory Medical Writing, the full-time Senior Manager Medical Writer will plan, author, and finalize clinical and regulatory documents for cell and gene therapy programs, ensuring compliance with US, EU, and ICH standards while working remotely.

Key responsibilities:

• Author clinical and regulatory documents, including INDs, protocols, and clinical study reports
• Manage document timelines and review workflows in Veeva Vault to ensure timely reviews and approvals
• Perform quality control and editorial review to maintain high standards for accuracy and clarity

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 for pharmaceuticals/biologics
• Experience in writing and reviewing regulatory submission documents for global filings is preferred
• Working knowledge of drug/biologics development, clinical research, and medical terminology
• Advanced skills in MS Word, Excel, and Adobe Pro