Über diese Medical Writer I Stelle bei ICON plc
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
We are currently seeking Medical Writer I to join our diverse and dynamic team. At this role you will be responsible for end-to-end preparation, quality control, and lifecycle management of clinical and regulatory documents within a GxP-compliant R&D environment. This Medical Writer assists as needed with ensuring that documents are processed within the Electronic Document Management System (EDMS). The ideal candidate will be an early-career professional with a strong interest to develop and grow into a Medical Writer role
What You Will Be Doing:
- 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 (MWs)
- Maintain EndNote Libraries and literature reference to support medical writing activities
- Support full CSR lifecycle including narrative coordination, appendices management, and submission readiness
- Support for MW with formatting of draft tables and documents
- QC checks of documents against source materials
- Document/Submission Plan preparation (trackers for Publishing)
- Final formatting of documents and technical checks for submission readiness
- Manage document workflows within EDMS (e.g., Veeva Vault), including upload, version control, approvals, and compliance tracking
Serve as a technical resource
- Manage multiple projects simultaneously and be a subject matter expert in document management system processes and procedures, which include granular clinical study reports and other regulatory documents; act as a liaison with functional area teams to manage workflows and approve documents.
- Serve as a technical expert for clinical research teams regarding the regulatory EDMS and regulatory publishing requirements
- Independently plan and execute assignments
Your Profile:
- 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)
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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- 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
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply
