Senior Medical Writer – Regulatory Writing

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🏄 California – Remote

🏄 California – Remote

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

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.

📋 Description

• The Senior Medical Writer is responsible for the development of medical writing deliverables that support the clinical regulatory writing portfolio • Preparing/Updating/Merging RMPs/Company Core-RMPs (CC-RMPs) • Managing scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Update Reports (PSURs) • Conducting critical appraisal and systematic review of literature with a focus on background epidemiology • Performing aggregate report compliance activities including quality review • Coordinates and liaises with the members of Study Management Team (SMT) • Prepares clear and accurate narratives based on Clinical Database and Safety Database outputs provided by the client • Responsible for the end-to-end signal management process

🎯 Requirements

• 5+ years of direct experience in Regulatory Writing in a CRO or Pharma company setting • Good knowledge of medical terminologies • Science/Medicine degree: A minimum qualification required would be a university degree in life Sciences/Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.) • A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Professional development opportunities