Senior Medical Writer - Fixed Term Contract

The role and involves working on clinical trial documents for Phase 1 and Phase 2 studies

Writing scope:

• Study protocols and protocol amendments
• Initial Investigator's Brochure (IB) and IB updates
• Clinical study reports

Responsibilities:

• Plan, write, review, and coordinate the development of regulatory clinical trial documents.
• Ensure and coordinate quality checks for accuracy, collate reviewer’s comments, adjust content of documents as required based on internal/external input, and prepare final versions.
• Ensure final documents and supporting quality check documentation (with all signatures where appropriate) are placed in the appropriate document management system.

Key experience and requirements:

• Bachelor’s Degree
• 2-3 years of prior experience writing regulatory or clinical trial documents - Protocols/Protocol amendments/IBs
• Demonstrated mastery of written and verbal English
• Demonstrated project management and time management skills
• High-level end-user computer skills (e.g., word processing, tables, and graphics)
• Ability to work well across cultures and time zones