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Medical Writer I

2-3 years
Not Disclosed
10 April 17, 2025
Job Description
Job Type: Hybrid Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Title

Medical Writer I

Location

Bangalore, India (Hybrid: Office/Home-Based)

Job ID

JR126927

Department

Medical Writing – ICON Full Service & Corporate Support

Hiring Manager

Puja Jaiswal

Application Status

Now Hiring – Applications are open
Apply Here on ICON Careers (link placeholder)


About ICON plc

ICON plc is a global leader in healthcare intelligence and clinical research, committed to driving innovation and excellence through a diverse and inclusive environment. From drug development to regulatory documentation, ICON supports pharmaceutical, biotechnology, medical device, and government organizations worldwide.

We are focused on transforming the future of clinical development—join us in shaping what’s next.


Role Overview

We are looking for a Medical Writer I with 2–3 years of experience in narrative writing for Clinical Study Reports (CSRs) and related regulatory documentation. The candidate must demonstrate a solid understanding of clinical research methodologies and medical writing best practices to ensure clarity, scientific integrity, and regulatory compliance.


Key Responsibilities

Narrative Writing

  • Write clear, accurate, and regulatory-compliant patient narratives for CSRs.

Data Interpretation

  • Summarize clinical data in line with scientific and regulatory standards.

Collaboration

  • Work closely with clinical research associates, biostatisticians, and medical monitors to ensure deliverables are met on time.

Compliance & Standards

  • Ensure adherence to ICH-GCP, FDA, EMA, and other regulatory requirements in medical writing outputs.

Editing & Review

  • Edit and review documents for clarity, grammar, consistency, and formatting before submission.

Documentation Management

  • Maintain version-controlled files and track document progress to ensure compliance with project timelines.


Candidate Profile

  • 2–3 years of experience in narrative writing, particularly in CSRs and regulatory documents.

  • Strong understanding of clinical trial processes and global regulatory frameworks (ICH-GCP, FDA, EMA).

  • Exceptional written and verbal communication skills.

  • Ability to interpret complex clinical data and present it clearly and concisely.

  • Proficiency in Microsoft Office Suite and experience with reference management tools.

  • Master’s degree in life sciences, pharmacy, or a related field.

    • Advanced degrees (MSc, PhD) are a plus.

  • Experience in writing additional clinical documents (e.g., protocols, submission documents) is desirable.


What ICON Offers

ICON offers a competitive salary along with a comprehensive range of benefits tailored to support your wellbeing and professional growth.

Benefits Include:

  • Various annual leave entitlements

  • Flexible health insurance options

  • Retirement planning programs

  • Global Employee Assistance Programme (LifeWorks)

  • Life assurance coverage

  • Optional country-specific perks:

    • Childcare vouchers

    • Bike-to-work schemes

    • Discounted gym memberships

    • Subsidized travel

    • Health assessments


Diversity, Equity & Inclusion

At ICON, inclusion and belonging are integral to our culture. We are committed to providing a workplace free from discrimination and harassment. All qualified applicants will receive equal opportunity without regard to race, religion, gender identity, sexual orientation, age, national origin, disability, or veteran status.

Accommodation: If you require assistance due to a medical condition or disability, reasonable accommodations are available throughout the recruitment process.