Overview
In this Medical Writer role, you support sponsor-aligned clinical development programs by delivering high-quality clinical documents.
You collaborate across teams to ensure timely, accurate, and compliant submissions and publications.
You will shape documentation strategy and provide lifecycle support from initial drafts to final versions.
This position offers impact on patient-focused research and an opportunity to contribute to Parexel's mission to improve global health.
Responsabilità
Document management within the EDMS
Review and approve Statistical Analysis Plans in the EDMS
Manage timelines and update schedules
Prepare for and attend trial team and submission meetings
Prepare, conduct, and document kick-off meetings
Prepare, conduct, and document Results Alignment Meetings
Draft documents with tables and figures within timelines
Manage review cycles and reconciliation of comments
Initiate/monitor Quality Control reviews and related docs




Create and deliver final document versions to project teams
Publishing support, pre-archive checks, and findings resolution
Electronic approval of final clinical documents in the EDMS
Technical and formatting checks for IBs and updates
Ensure compliance with sponsor processes and SOPs
Participate in governance, feedback, and alignment meetings
Requisiti fondamentali
5 years' experience in medical writing
Scientific degree and/or advanced scientific degree
Knowledge of ICH GCP, regulatory requirements, and clinical trial processes
Experience with clinical document management systems and related tools
Strong communication, organization, and problem solving skills
Good collaboration and attention to detail with a patient-focused mindset
collaboration and communication
attention to detail
problem solving
EDMS
ICH GCP knowledge
regulatory requirements understanding

📌 Senior Medical Writer - Sponsor Dedicated - Italy Remote (Emilia-Romagna)
🏢 Parexel
📍 Emilia-Romagna