Documentation Specialist – Medical Writer

🔥 49 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

• Develop and maintain clinical and regulatory documents including CTRs, CTPs, protocol amendments, IBs, biomarker reports, and submission documents • Manage clinical documents within the Electronic Document Management System (EDMS), including document setup, workflow management, and approvals • Establish, communicate, and maintain agreed project timelines in collaboration with trial and project teams • Prepare for, facilitate, and document project meetings, kick off meetings, Results Alignment Meetings, trial team meetings, and submission meetings as required • Draft clinical documents, including appropriate in text tables and figures, in accordance with agreed timelines and applicable procedures • Coordinate and manage document review cycles, drive alignment on comments, integrate revisions, and complete required review documentation • Initiate, conduct, or oversee quality control activities and complete supporting quality control documentation • Finalize and deliver completed documents to project teams and support document publishing and pre archive activities • Perform technical and formatting checks for Investigator's Brochures and related updates • Support final electronic approval processes and ensure compliance with established procedures, systems, and standard operating procedures • Collaborate effectively within an integrated team environment and participate in ongoing project governance, feedback, and alignment activities

🎯 Requirements

• Experience with technical writing or medical writing • Experience working in clinical research or another regulated environment • The ability to collaborate across teams and communicate clearly with a variety of stakeholders • A quality focused mindset and strong attention to detail • Comfort working with electronic document management systems, document review processes, and quality control procedures • Bachelor's degree or equivalent combination of education and relevant experience • Knowledge of clinical development documentation processes and regulated working environments • Experience working with Electronic Document Management Systems (EDMS) and document lifecycle management processes • Strong communication, organization, stakeholder management, and problem-solving skills

🏖️ Benefits

• Flexible work arrangements • Professional development opportunities