Senior Medical Writer

🔥 2 hours 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

• Act as an integrated resource within the team, delivering Medical Writing Services for the creation of clinical documents including CTRs, CTPs and amendments, IBs and updates, biomarker reports, and submission documents. • Collaborate closely within a dedicated sponsor aligned environment. • Manage document timelines and ongoing schedule updates. • Prepare and attend trial team and submission meetings. • Conduct Results Alignment Meetings where applicable. • Write drafts including tables and figures according to agreed timelines. • Manage review cycles, comment reconciliation, and documentation. • Conduct Quality Control reviews and associated documentation. • Create and provide final document versions to project teams. • Support electronic approval of final clinical documents in the EDMS.

🎯 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 • creating space for people to do their best work