Medical Writer

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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

• Support the set-up and maintenance of clinical documents within the Electronic Document Management System (EDMS). • Review document status and assist with document workflow activities within sponsor systems. • Coordinate document timelines and support project teams by tracking key deliverables. • Prepare meeting materials and attend trial team and submission meetings, documenting actions and outcomes as required. • Support the organization and documentation of kick-off meetings and Results Alignment Meetings. • Draft sections of clinical documents and contribute to the preparation of tables, figures, and supporting content. • Coordinate document review activities and support the collection and incorporation of stakeholder feedback. • Assist with Quality Control activities and completion of required documentation. • Support preparation of final document packages for review, publishing, and archiving activities. • Complete technical and formatting checks for Investigator Brochures and related clinical documents. • Maintain accurate records and documentation in accordance with sponsor procedures and SOPs.

🎯 Requirements

• Scientific degree and/or advanced scientific degree • 1-3 years of experience within medical writing • Knowledge of ICH-GCP, regulatory requirements, and clinical trial processes • Experience working with document management systems and clinical development documentation • Strong communication, organizational, and problem-solving skills.

🏖️ Benefits

• Flexible working hours