Medical Writer I

🔥 0 minutes ago

🌐 United Kingdom, Poland, +2 more countries – Remote

🇬🇧 United Kingdom – Remote 🇵🇱 Poland – Remote 🇪🇸 Spain – Remote 🇿🇦 South Africa – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥📝 Medical Writer

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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) to ensure inspection readiness and compliance with ICH guidelines and GxP requirements • Maintain EndNote libraries and literature references to support medical writing activities • Support the full Clinical Study Report (CSR) lifecycle, including narrative coordination, appendices management, and submission readiness • Format draft tables and documents for medical writers • Perform document QC checks against source materials • Prepare Document/Submission Plans and publishing trackers • Complete final document formatting and technical checks for submission readiness • Manage document workflows within the Electronic Document Management System (EDMS), including upload, version control, approvals, and compliance tracking • Serve as a technical resource and subject matter expert in document management system processes and procedures • Liaise with functional area teams to manage workflows and approve documents • Advise clinical research teams on regulatory EDMS and regulatory publishing requirements • Independently plan and execute assignments • Prepare, quality-control, and manage the lifecycle of clinical and regulatory documents in a GxP-compliant R&D environment • Assist with processing documents within the EDMS

🎯 Requirements

• Bachelor’s degree or 3–5+ years of related experience is required; scientific field preferred • Experience preparing documents for submission using Regulatory/EDMS, such as Veeva Vault, preferred • Strong working knowledge of Adobe Acrobat and Microsoft Word • Advanced computer proficiency • Expert knowledge of Microsoft Word, including templates, automation, and styles • Knowledge of Adobe QC tools • Proficiency with AI tools preferred • Working knowledge of document template use and maintenance • Knowledge of electronic submission requirements for regulatory authorities and records management • Knowledge of ICH E3 and E6 requirements • Knowledge of CFR 21 Part 11 requirements • Ability to manage multiple projects simultaneously • Ability to independently plan and execute assignments • 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 • Inclusive and accessible workplace • Reasonable accommodations during the recruitment process