Regulatory Medical Writer II

🔥 4 minutes ago

🌐 United Kingdom, Greece, +2 more countries – Remote

🇬🇧 United Kingdom – Remote 🇬🇷 Greece – Remote 🇿🇦 South Africa – Remote 🇵🇹 Portugal – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥📝 Medical Writer

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

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

• Take ownership of high-complexity Phase II-IV clinical regulatory documents • Manage the full document lifecycle from planning and stakeholder engagement through drafting, review, and final delivery • Author protocols, protocol outlines, ICFs, investigator brochures, lay summaries, and regulatory briefing packages • Lead document planning, review, and approval activities across geographically distributed teams • Interpret efficacy, safety, exposure, and endpoint data to develop clear scientific content • Build alignment between cross-functional stakeholders and facilitate efficient document development • Manage timelines, resolve comments, and ensure projects progress as planned • Collaborate with Biostatistics, Data Management, Programming, Clinical Leadership, Project Physicians, and global Medical Writing teams

🎯 Requirements

• 3 years of regulatory medical writing experience • Minimum of 1 year leading medical writing projects • Experience independently authoring and managing clinical regulatory documents • Knowledge of ICH guidelines and regulatory requirements • Strong scientific communication and stakeholder management skills • Degree in Life Sciences required • PhD preferred

🏖️ Benefits

• Training, support, and professional network to help you grow • Opportunities to deepen scientific expertise or progress toward senior and leadership roles • Exposure to global development programmes • Collaboration with experienced stakeholders across multiple functions • Continued development of project leadership capabilities