Principal Medical Writer – Clinical Pharmacology (m/w/d)
On-siteDublin, Leinster, Ireland
Job Summary
Lead full Clinical Study Report (CSR) writing for Phase 1 clinical pharmacology studies, including protocol development and preparation of regulatory modules 2.7.1/2.7.2. Ensure all deliverables are inspection-ready and compliant with regulatory and internal guidelines while maintaining central planning for document writing and quality control. Drive document shell creation, QC processes, and timeline management, providing recommendations for process improvements to enhance collaboration between CPP and document service teams. Author Health Authority responses and maintain proficiency in Word templates and document formatting to ensure high-quality, inspection-ready outputs.
Required Qualifications
- Strong experience in writing full CSR for Phase 1 clinical pharmacology studies
- Strong experience on protocol writing and Module 2.7.1/2.7.2 (SBAAM/SCP) writing
- Proficient with word templates and document formatting
- Experience authoring Health Authority responses
- Excellent communication skills (oral and written) in English
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