Medical Writer I
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Job Description
Medical Writer supporting ICON’s global healthcare intelligence and clinical research organization. Managing clinical and regulatory document QC, EDMS workflows, and submission readiness.
Responsibilities:
- 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
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