Job Description
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-quality output. Drive innovation through the implementation of AI medical writing tool...
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-quality output. Drive innovation through the implementation of AI medical writing tool...
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