Senior Regulatory Medical Writer

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🔥 16 minutes ago

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• Lead the development cycle for high-complexity Phase II-IV clinical regulatory documents • Participate in strategy meetings to align teams and set milestones • Conduct communication strategy meetings and resolve comments early • Maintain alignment with project goals across teams • Author study-level documents like protocols, lay summaries, and briefing packages

🎯 Requirements

• Advanced degree in life-sciences, PhD or Masters • Minimum 4 years of regulatory medical writing experience • At least 2 years as medical writing project lead • Independent authoring capability • Proactive collaboration with stakeholders

🏖️ Benefits

• Comprehensive training • Management support • Opportunities for career advancement