Lead Medical Writer

🔥 8 minutes ago

🌐 Brazil, Mexico – Remote

🇧🇷 Brazil – Remote 🇲🇽 Mexico – Remote

⏰ Full Time

🟠 Senior

🏥📝 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 and execution of medical writing strategies for clinical research projects • Own medical writing deliverables and apply expertise to complex challenges • Lead the preparation, review, and editing of clinical study protocols, clinical study reports, investigator brochures, and regulatory submissions • Collaborate with clinical research, biostatistics, regulatory affairs, and medical affairs teams to interpret clinical trial data and summarize scientific findings • Participate in planning and execution of clinical development programs • Provide strategic input and scientific expertise for the design, conduct, and interpretation of clinical studies and research initiatives • Contribute to publication plans, abstracts, posters, and manuscripts for peer-reviewed journals and scientific conferences • Mentor and coach junior medical writers on best practices, writing techniques, and scientific principles • Foster excellence, collaboration, and continuous learning within the medical writing team

🎯 Requirements

• Bachelor's degree in a relevant scientific discipline or healthcare-related field • Proficiency in interpreting and summarizing complex clinical trial data, scientific research findings, and statistical analyses • Excellent writing, editing, and proofreading skills • Strong understanding of regulatory requirements, including ICH-GCP, FDA, and EMA, governing the preparation and submission of clinical documents and publications • Experience interacting with regulatory agencies during the review and approval process • Ability to work effectively in a fast-paced, deadline-driven environment • Ability to manage multiple projects simultaneously and prioritize tasks based on project timelines and deliverables • Excellent interpersonal and communication skills • Ability to collaborate effectively with cross-functional teams, build relationships with key stakeholders, and influence decision-making processes • 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