Manager Medical Writing

Medical Writing Manager – Clinical & Regulatory

Overview

Management-level medical writing role leading the development, coordination, and delivery of clinical and regulatory documents supporting global R&D programs.

Key Responsibilities

• Lead planning, authoring, and review of key clinical & regulatory documents (e.g. protocols, IBs, CSRs, paediatric plans, HA responses, submission dossiers).
• Ensure scientific accuracy, consistency, and compliance with ICH, GCP, and global regulatory standards.
• Provide strategic input into document planning, submission strategy, and global regulatory timelines.
• Partner cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, Safety, and external stakeholders.
• Review and quality-check internally and externally authored documents.
• Develop and maintain writing standards, templates, and SOPs.
• Mentor and guide medical writers to ensure high-quali...