ICON is hiring for a Medical Writer I position in India, with the role listed under Bangalore and available as home-based or office-based. This opportunity is suitable for early-career professionals interested in clinical and regulatory medical writing.

The selected candidate will support clinical study reports, Trial Master File quality checks, document formatting, regulatory submissions, literature references, and electronic document management. Candidates familiar with Microsoft Word, Adobe Acrobat, ICH guidelines, and Veeva Vault may have an advantage.

Quick Answer: ICON is hiring for the Medical Writer I role in Bangalore, India, with office-based and home-based working options. Candidates with a bachelor’s degree or at least two years of related experience and skills in clinical documentation, EDMS, Microsoft Word, Adobe Acrobat, and regulatory submissions can apply.

ICON Medical Writer I Job Overview

About the Medical Writer I Role

The ICON Medical Writer I position focuses on the end-to-end preparation, quality control, formatting, submission readiness, and lifecycle management of clinical and regulatory documents.

The Medical Writer will work in a GxP-compliant research and development environment. The role also involves managing documents within an Electronic Document Management System such as Veeva Vault and supporting experienced medical writers with clinical study documentation.

Although this is titled a Medical Writer I position, several responsibilities relate to regulatory document management, TMF quality control, clinical study report support, publishing trackers, and submission formatting.

Key Responsibilities

The Medical Writer I will be responsible for:

• Performing Trial Master File quality-control checks to maintain inspection readiness.
• Reviewing medical writing documents for compliance with GxP and ICH E3 and E6 guidelines.
• Maintaining EndNote libraries and literature references.
• Supporting the complete Clinical Study Report lifecycle.
• Coordinating patient narratives and managing CSR appendices.
• Preparing clinical and regulatory documents for submission.
• Formatting draft tables, reports, and supporting documents.
• Comparing documents with source materials and identifying inconsistencies.
• Preparing document and submission plans, including publishing trackers.
• Conducting final formatting and technical checks before submission.
• Uploading and managing documents within an Electronic Document Management System.
• Managing document versions, approvals, workflows, and compliance tracking.
• Supporting granular clinical study reports and other regulatory documents.
• Coordinating with functional teams to manage document workflows.
• Advising clinical research teams on EDMS and regulatory publishing requirements.
• Managing multiple projects and assignments independently.

Qualifications and Eligibility

Candidates should meet one of the following requirements:

• A bachelor’s degree; a degree in a scientific field is preferred.
• Alternatively, at least two years of related professional experience.

Based on the scientific preference and responsibilities, candidates from the following educational backgrounds may be relevant:

• B.Pharm or M.Pharm
• Pharm.D
• B.Sc or M.Sc in Life Sciences
• Biotechnology
• Microbiology
• Biochemistry
• Clinical Research
• Biomedical Sciences
• Other relevant scientific disciplines

These specific degree backgrounds are suitability examples based on the role. The official job description only requires a bachelor’s degree or two or more years of related experience, with a scientific field preferred.

Technical Skills Required

• Advanced Microsoft Word proficiency
• Microsoft Word templates, styles and automation
• Adobe Acrobat and Adobe quality-control tools
• Electronic Document Management Systems
• Veeva Vault or a comparable regulatory EDMS
• EndNote reference management
• Document formatting and technical quality control
• Document version control and approval workflows
• Regulatory submission preparation
• Document template maintenance
• AI tools for documentation support, preferred

Domain Knowledge

Candidates should understand or be willing to develop knowledge of:

• Clinical and regulatory medical writing
• Clinical Study Reports
• CSR narratives and appendices
• Trial Master File quality control
• GxP documentation requirements
• ICH E3 and ICH E6 guidelines
• Electronic regulatory submissions
• Regulatory publishing requirements
• Records and document lifecycle management
• CFR 21 Part 11 requirements
• Submission-readiness quality checks

Soft Skills

• Strong written communication
• Attention to detail
• Quality-focused working approach
• Ability to manage multiple projects
• Cross-functional collaboration
• Planning and organizational ability
• Independent execution
• Problem-solving skills
• Ability to work within controlled processes and timelines

Is This Position Suitable for Freshers?

The Medical Writer I role is described as an opportunity for an early-career professional with a strong interest in developing as a medical writer.

Candidates with a relevant bachelor’s degree may therefore be considered even without two years of experience. However, applicants should ideally demonstrate knowledge of clinical documentation, Microsoft Word, Adobe Acrobat, regulatory guidelines, or electronic document management.

Final eligibility and shortlisting will be decided by ICON based on the candidate’s education, skills and overall profile.

Estimated Salary for ICON Medical Writer I

The official job description does not disclose a salary.

The estimated salary range is ₹4.5 lakh to ₹8 lakh per annum. This is an indicative market estimate for an early-career medical writing and regulatory documentation position in India. The actual package may vary depending on experience, education, location, technical proficiency and ICON’s internal compensation structure.

Rewards and Benefits

ICON states that eligible employees may receive:

• Competitive base salary
• Performance-related incentives
• Medical, dental and vision coverage, where applicable
• Health and wellbeing programmes
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes
• Wellbeing resources
• Structured learning and development opportunities
• Defined career-development pathways

Benefits may vary depending on the role and work location.

How to Apply

Application Link