Medical Writer I

🔥 0 minutes ago

🌐 Ireland, Poland, +1 more countries – Remote

🇮🇪 Ireland – Remote 🇵🇱 Poland – Remote 🇿🇦 South Africa – 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

• Perform Trial Master File (TMF) Quality Control (QC) ensuring inspection readiness and compliance with ICH guidelines (E3, E6)/GxP requirements for documents prepared by medical writers • Maintain EndNote Libraries and literature reference to support medical writing activities • Support full CSR lifecycle including narrative coordination, appendices management, and submission readiness • Support medical writers with formatting of draft tables and documents • Perform QC checks of documents against source materials • Prepare Document/Submission Plans and publishing trackers • Perform final formatting of documents and technical checks for submission readiness • Manage document workflows within EDMS such as Veeva Vault, including upload, version control, approvals, and compliance tracking • Serve as a technical resource and subject matter expert in document management system processes and procedures • Manage multiple projects and liaise with functional area teams to manage workflows and approve documents • Serve as a technical expert for clinical research teams regarding regulatory EDMS and regulatory publishing requirements • Independently plan and execute assignments

🎯 Requirements

• Bachelor’s degree or 3-5+ years of related experience is required; scientific field preferred • Experience in the preparation of documents for submission using Regulatory/EDMS preferred, e.g., Veeva Vault • Strong working knowledge of Adobe Acrobat and Microsoft Word is essential • Advanced computer proficiency required, including expert knowledge of Microsoft Word (templates, automation, styles) and adobe QC tools • Proficiency with AI tools, preferred • Working knowledge of the use and maintenance of document templates • Knowledge of requirements for electronic submissions to regulatory authorities and records management required (e.g., ICH (E3 &E6), CFR 21 Part 11) • 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