Medical Writer II

🔥 0 minutes ago

🌐 United Kingdom, Romania – Remote

🇬🇧 United Kingdom – Remote 🇷🇴 Romania – Remote

⏰ Full Time

🟡 Mid-level

🟠 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

• Guide medical writing document preparation, including coordination of assignments to writers, review, and substantive editing • Assume primary responsibility when necessary for key regulatory response documents and documents supporting major regulatory submissions • Formulate writing approaches, develop timelines, and assess resource requirements for key documents and regulatory submissions • Participate on relevant project teams and task forces • Provide functional and cross-functional guidance on document preparation, international regulatory guidance and requirements, work requirements, and project- or therapeutic-area-specific guidance • Lead writing strategy covering organization, content, timelines, and resource requirements • Provide advanced input for study designs, analysis plans, sections of INDs, and marketing applications • Review and substantively edit contributions and ensure resolution of issues • Manage deliverables and document preparation for submission to regulatory agencies • Ensure consistency of content and adherence to regulatory and sponsor requirements across development programs • Represent Medical Writing on cross-functional teams and task forces • Act as a key Medical Point of contact for clinical regulatory strategy • Serve as lead writer for important regulatory response documents and key components of regulatory submissions • Provide leadership on functional teams addressing document preparation and production requirements or issues • Perform medical writing work independently with minimal supervision as a Principal Medical Writer

🎯 Requirements

• Bachelor’s degree in science, health profession required • At least 3 years of experience writing for pharma or biotechnology preferred • 3+ years of electronic documents and submissions required • Experience with writing key documents like Clinical study reports, IBs, Protocols • Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products • Understanding of international regulations, ICH guidelines, and applicable international regulatory processes related to document preparation and production (including CTDs) • Well-developed oral and written communication skills • Ability to clearly present technical information within and across functional areas • Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within functional and cross-functional teams and with external providers • 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