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 datore di lavoro: Parexel
La nostra azienda è un datore di lavoro eccezionale, offrendo un ambiente di lavoro stimolante e collaborativo per i professionisti delle affari regolatori nel settore dei dispositivi medici. Con opportunità di crescita professionale e un forte impegno per l'innovazione, i dipendenti possono contribuire attivamente a strategie globali mentre lavorano in diverse località europee, sia da casa che in ufficio. Inoltre, la cultura aziendale promuove il supporto reciproco e il miglioramento continuo, rendendo ogni giorno significativo e gratificante.
