Principal Medical Writer, FSP

October 1

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Parexel

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Healthcare Insurance • Biotechnology • Pharmaceuticals

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.

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

📋 Description

• Write and oversee completion of a broad range of clinical and regulatory documents • Work with the lead and/or program medical writer to develop messages and data presentations • Independently write, substantively rewrite, and edit documents for clarity and accuracy • Help manage project documents and timelines to meet submission deadlines • Ensure documents comply with ICH guidelines, Sponsor SOPs, Good Clinical Practices, and Good Publication Practices • Provide writing support for investigator’s brochures, clinical study protocols and reports, integrated summaries, literature reviews, and SOPs • Collaborate with domestic and international colleagues across R&D and project teams • Comply with Parexel standards (training curriculum, timesheets, expense reports, CV updates)

🎯 Requirements

• At least 4 years of writing experience in the pharmaceutical industry • Experience with a variety of regulatory and clinical documents • Experience in a matrix team environment • Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents • Ability to write and edit complex material to ensure accuracy and clarity • Excellent written and oral communication skills • Demonstrated problem-solving abilities • Ability to handle multiple projects and short timelines • Ability to work cooperatively with colleagues in a wide range of disciplines • BA/BS or higher

🏖️ Benefits

• Remote work (United States or Canada)