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 (Como)
🏢 Parexel
📍 Como