Medical Writer I

Medical Writer I

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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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What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply