Medical Writer I

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Logo of Parexel

Parexel

10,000+ employees

Founded 1983

đŸ’Œ Consulting

đŸ„ 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

‱ Author, edit, and review clinical and regulatory documents, including: Clinical Study Reports (CSRs), Interim Study Reports, Informed Consent Forms (ICFs), Safety Update Reports, Patient Narratives. ‱ Conduct literature searches and scientific reviews to support document development. ‱ Analyze and interpret clinical study data to prepare high-quality scientific content. ‱ Ensure compliance with ICH-GCP guidelines, SOPs, templates, and regulatory requirements. ‱ Perform quality checks to ensure data accuracy, consistency, and document integrity. ‱ Collaborate with cross-functional teams including Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, and Medical Affairs. ‱ Support document review cycles, manage timelines, and address stakeholder feedback.

🎯 Requirements

‱ Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Medicine, or related healthcare discipline. ‱ Strong clinical and scientific writing skills. ‱ Good understanding of clinical research, drug development, and regulatory guidelines. ‱ Experience with medical writing, clinical documentation, or medical communications. ‱ Excellent written and verbal communication skills. ‱ Strong attention to detail and organizational skills. ‱ Proficiency in Microsoft Word, Excel, SharePoint, and document management systems. ‱ Ability to manage multiple projects and work effectively in a collaborative environment.

đŸ–ïž Benefits

‱ Health insurance ‱ Retirement plans ‱ Paid time off ‱ Flexible work arrangements ‱ Professional development

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