Principal Medical Writer

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🔥 0 minutes ago

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

🇬🇧 United Kingdom – Remote 🇪🇸 Spain – Remote 🇵🇱 Poland – Remote 🇿🇦 South Africa – Remote

⏰ Full Time

🔴 Lead

🏥📝 Medical Writer

👻 Ghost score 10%

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Lead the development of high-quality regulatory and clinical documents communicating scientific and medical information • Oversee medical writing workstreams and ensure deliverables meet quality and timeline expectations • Lead preparation and review of clinical study reports, protocols, and other regulatory documents • Collaborate with clinical research, biostatistics, and regulatory affairs teams to gather and synthesize information • Provide guidance on medical-writing best practices and ensure adherence to regulatory requirements and internal standards • Mentor and train junior medical writers • Stay current with industry trends and regulatory guidelines • Act as lead medical writer for complex projects and lead clinical/regulatory marketing approval applications for new biologics and drugs • Perform all Senior Medical Writer duties plus leadership of regulatory approval application writing

🎯 Requirements

• A bachelor's degree in life sciences, pharmacy, or a related discipline • Significant experience in medical writing, particularly in regulatory submissions and clinical documentation • Strong understanding of regulatory requirements and industry standards for clinical writing • Exceptional writing and editing skills, with a keen eye for detail and clarity • At least 5 years of experience writing for pharma or biotechnology preferred • 3+ years of electronic documents and submissions required • Experience with writing key documents included in major international regulatory submissions required, including Clinical study reports, IBs, and Protocols • Experience managing writing activities for a major international regulatory submission preferred • Legal right to work in the country where the role is based

🏖️ Benefits

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways