Senior Medical Writer, Sponsor Dedicated

🔥 27 minutes ago

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Delivering Medical Writing Services for the creation of clinical documents including CTRs, CTPs and amendments, IBs and updates, biomarker reports, and submission documents. • Document management within the EDMS. • Review and approval of Statistical Analysis Plans in the EDMS. • Management of timelines and ongoing schedule updates. • Preparation for and attendance at trial team and submission meetings. • Preparation, conduct, and documentation of kick off meetings. • Preparation, conduct, and documentation of Results Alignment Meetings where applicable. • Writing of drafts including tables and figures according to agreed timelines. • Management of review cycles, comment reconciliation, and review documentation. • Initiation, monitoring, or conduct of Quality Control reviews and associated documentation. • Creation and provision of final document versions to project teams. • Publishing support, pre archive checks, and resolution of findings. • Electronic approval of final clinical documents in the EDMS. • Technical and formatting checks for IBs and updates. • Compliance with sponsor processes and SOPs. • Participation in governance, feedback, and alignment meetings.

🎯 Requirements

• Previous Medical Writer or Senior Medical Writer experience. • Strong collaboration and communication skills. • Excellent attention to detail and document quality focus. • A patient focused mindset and commitment to advancing clinical research. • Scientific degree and/or advanced scientific degree. • 5 years’ experience within medical writing. • 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.

🏖️ Benefits

• Flexibility, growth, and creating space for people to do their best work • Professional development