Medical Writer I

Medical Writer I - India - Home-Based

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 2+ 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)

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