Regulatory Medical Writer III
RemoteUnited Kingdom or Spain
United Kingdom or SpainRemoteFull TimeSenior LevelDoctorate Or Professional DegreeLarge
Full TimeSenior LevelDoctorate Or Professional DegreeLarge
Job Summary
Lead authoring and development of high-complexity Phase II-IV clinical regulatory documents, owning the end-to-end medical writing process from initial planning through final delivery. Drive kick-off strategy meetings to align geographically distributed teams and facilitate comment resolution to manage conflicting inputs early. Critically interpret raw study data into clear language for protocols, CSRs, IBs, and regulatory briefing packages. Coordinate functional leads from biostatistics, data management, programming, and clinical leadership while maintaining alignment with sponsor goals and project milestones.
Required Qualifications
- Advanced degree in life-sciences, PhD or Masters
- Minimum 4 years of regulatory medical writing experience
- At least 2 years as medical writing project lead
- Independent authoring
- Proactively collaborating with stakeholders to author content
- Drive discussions
- Manage the authoring/review process
- Visibility
- Proactivity
- Collaboration/teamwork
- Excellent communication skills
- Comfortable leading team discussions
- Managing complex medical writing tasks and processes
- Engaging with a variety of stakeholders
- Confidently contributing your expertise based on experience
- Readiness to assume augmented responsibilities
- Adaptability across environments and therapeutic areas
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