ICON plc
10,000+ employees
Founded 1990
đŒ Consulting
đ„ Healthcare
đŠ Logistics
Consulting âą Healthcare âą 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.
Principal Medical Writer
Job not on LinkedIn
đ„ 0 minutes ago
đ France, United Kingdom, +1 more countries â Remote
â° Full Time
đŽ Lead
đ„đ Medical Writer
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ICON plc
10,000+ employees
Founded 1990
đŒ Consulting
đ„ Healthcare
đŠ Logistics
Consulting âą Healthcare âą 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.
đ Description
âą Lead the development of high-quality regulatory and clinical documents communicating scientific and medical information âą Oversee medical writing workstreams and ensure deliverables meet quality and timeline expectations âą Lead preparation and review of clinical study reports, protocols, and other regulatory documents âą Collaborate with clinical research, biostatistics, and regulatory affairs teams to gather and synthesize information âą Provide guidance on medical writing best practices and ensure adherence to regulatory requirements and internal standards âą Mentor and train junior medical writers âą Monitor industry trends and regulatory guidelines to inform writing practices âą Act as lead medical writer for complex projects and lead clinical/regulatory marketing approval applications for new biologics and drugs âą Lead regulatory approval application writing
đŻ Requirements
âą Bachelor's degree in life sciences, pharmacy, or a related discipline âą Significant experience in medical writing, particularly in regulatory submissions and clinical documentation âą Strong understanding of regulatory requirements and industry standards for clinical writing âą Exceptional writing and editing skills, with a keen eye for detail and clarity âą Excellent communication and interpersonal skills âą Ability to manage competing priorities and develop your team âą Legal right to work in the country where the role is based
đïž Benefits
âą Competitive base salary and performance related incentives âą Health and wellbeing programmes including medical, dental, and vision coverage where applicable âą Retirement and pension plans âą Life assurance and disability coverage âą Employee assistance programmes and wellbeing resources âą Learning and development opportunities through structured training and career pathways
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