Principal Medical Writer – Clinical Pharmacology (m/w/d)
IQVIA
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Full clinical study report writing for phase 1
Protocol development and module 2.7.1/2.7.2 writing
Health authority response authoring experience
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IQVIA is seeking a Principal Medical Writer specializing in Clinical Pharmacology to produce high-quality deliverables for clinical studies, focusing on CSR writing and regulatory compliance. The ideal candidate should possess strong writing skills, extensive experience in clinical documentation, and proficiency in managing timelines and quality control.
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Job Summary
The role focuses on supporting full Clinical Study Report writing for Phase 1 clinical pharmacology studies alongside protocol development.
Candidates must ensure all deliverables are inspection-ready and compliant with regulatory guidelines while managing central planning for document writing.
Proficiency in authoring Health Authority responses is a mandatory requirement for this position within the global life sciences sector.
Matching Summary
Match Score: 75
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IQVIA is seeking a Principal Medical Writer specializing in Clinical Pharmacology to produce high-quality deliverables for clinical studies, focusing on CSR writing and regulatory compliance. The ideal candidate should possess strong writing skills, extensive experience in clinical documentation, and proficiency in managing timelines and quality control.
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Skills & Requirements
Must-have
Full Clinical Study Report writing for Phase 1
Protocol development and Module 2.7.1/2.7.2 writing
Health Authority response authoring experience
Inspection-ready deliverable maintenance
Document shell creation and QC processes
Nice-to-have
Process improvement recommendations
Collaboration between CPP and document service teams