Parexel
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.
Senior Medical Writer – FSP
🔥 0 minutes ago
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Parexel
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 Clinical Trial Reports, Clinical Trial Protocols, protocol amendments, Investigator's Brochures, biomarker reports, and submission documents • Manage clinical documents within the Electronic Document Management System, including document setup, workflow management, and approvals • Establish, communicate, and maintain project timelines with trial and project teams • Prepare, facilitate, and document project, kick-off, Results Alignment, trial team, and submission meetings • Draft clinical documents with appropriate in-text tables and figures • Coordinate document review cycles, drive alignment on comments, integrate revisions, and complete review documentation • Initiate, conduct, or oversee quality control activities and complete supporting documentation • Finalize and deliver completed documents and support 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 procedures, systems, and standard operating procedures • Collaborate within integrated cross-functional teams and participate in project governance, feedback, and alignment activities
🎯 Requirements
• 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 and document lifecycle management processes • Strong medical writing, project coordination, and document management capabilities • Experience working in clinical research or another regulated environment • Ability to collaborate across teams and communicate clearly with varied stakeholders • Quality-focused mindset and strong attention to detail • Comfort with electronic document management systems, document review processes, and quality control procedures • Strong communication, organization, stakeholder management, and problem-solving skills • Advanced scientific, life sciences, or related educational background preferred • Experience supporting clinical trial documentation and regulatory submissions preferred • Familiarity with clinical document review, quality control, publishing, and approval workflows preferred • Experience collaborating within cross-functional clinical development teams preferred
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