Principal Medical Writer

🔥 0 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🔴 Lead

🏥📝 Medical Writer

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

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

• Oversee medical writing workstreams, ensuring deliverables meet quality and timeline expectations • Lead the preparation and review of clinical study reports, protocols, and other regulatory documents to ensure accuracy and clarity • Collaborate with cross-functional teams to gather and synthesize information for document development • Provide guidance on best practices for medical writing and ensure adherence to regulatory requirements and internal standards • Mentor and train junior medical writers, fostering a culture of excellence and professional growth • Stay current with industry trends and regulatory guidelines to inform writing practices and maintain high-quality outputs • Act as a lead medical writer for complex projects and lead clinical/regulatory marketing approval applications for new biologics and drugs

🎯 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 • Excellent communication and interpersonal skills, enabling effective collaboration with diverse teams and stakeholders

🏖️ 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