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Full-time
bachelor degree
Competitive base salary, Performance related incentives, Medical coverage, Dental coverage, Vision coverage, Retirement plans
Posted 1d ago
~40 hrs/week
Remote in Swansea, Wales, United Kingdom
Responsibilities
The Medical Writer I is responsible for the end-to-end preparation, quality control, and lifecycle management of clinical and regulatory documents within a GxP-compliant environment. They will also manage document workflows in the EDMS and ensure inspection readiness for clinical study reports.
Requirements
Candidates must hold a bachelor's degree or have 3-5 years of relevant experience, with a preference for those familiar with regulatory document preparation. Proficiency in Microsoft Word, Adobe Acrobat, and document management systems like Veeva Vault is essential.
Full job description
Medical Writer I
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)
#LI-NR1
#LI-Remote
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
Related keywords
Medical WriterClinical ResearchGxPR&DEDMSVeeva VaultTMFICH E3ICH E6CFR 21 Part 11Regulatory AffairsSubmission ReadinessDocument ControlQuality AssuranceAdobe AcrobatMicrosoft Word
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.
We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
Offices: ICON plc, South County Business Park, Leopardstown, Dublin, D18 X5R3, IE · 123 Smith Street, Farmingdale, New York NY 11735, US · Block 2, Hamilton House, National Technology Park, Limerick, V94 TRW8, IE · 100 Longwater Avenue, Green Park, 3rd Floor, North and South Wings, Reading, England RG2 6GP, GB · 1 Almondview Office Park, West Lothian, Livingston, EH54 6SF, GB
Medical DeviceTherapeuticsGovernment and Public Health SolutionsClinical Research ServicesCommercialisation and OutcomesOncologyValue Based HealthcareClinical TrialsPatient RecruitmentInnovation
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