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Medical Writer I

2-3 years
Not Disclosed
10 April 3, 2025
Job Description
Job Type: Full Time 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

 


Medical Writer I – India (Bangalore, Office or Home-Based)

Company: ICON plc
Location: Bangalore, India (Office or Remote)
Category: Medical Writing / Clinical Research
Job Type: Full-time


About ICON plc

ICON plc is a leading global healthcare intelligence and clinical research organization dedicated to driving innovation and excellence in clinical development. ICON fosters an inclusive and diverse work environment and is committed to shaping the future of clinical research.


Job Summary

ICON is seeking a Medical Writer I with 2-3 years of experience in narrative writing for Clinical Study Reports (CSRs) and regulatory documentation. The role involves summarizing clinical data, collaborating with research teams, and ensuring compliance with industry regulations.


Key Responsibilities

Narrative Writing & Data Interpretation

  • Develop and write patient narratives for clinical study reports.

  • Summarize clinical data with accuracy and adherence to scientific and regulatory guidelines.

Collaboration & Compliance

  • Work with clinical research teams, biostatisticians, and medical monitors to ensure timely deliverables.

  • Ensure compliance with ICH-GCP, FDA, EMA, and company medical writing standards.

Editing, Review & Documentation

  • Review and edit documents for clarity, grammar, consistency, and regulatory readiness.

  • Maintain version-controlled files and track document progress to meet deadlines.


Required Qualifications & Skills

Experience & Technical Knowledge

  • 2-3 years of experience in narrative writing for CSRs and regulatory documentation.

  • Strong knowledge of clinical trial processes and regulatory requirements (ICH-GCP, FDA, EMA).

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

  • Familiarity with Microsoft Office Suite (Word, Excel, PowerPoint) and reference management software.

Education

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

  • MSc or PhD is a plus.

Soft Skills

  • Excellent written and verbal communication skills.

  • Strong attention to detail and organizational abilities.


What ICON Offers

Competitive Compensation & Benefits

  • Attractive salary package with industry-leading perks.

  • Annual leave entitlements.

  • Comprehensive health insurance for employees and families.

  • Competitive retirement planning options.

  • Employee Assistance Programme (TELUS Health) with access to 24/7 professional support.

  • Flexible work benefits (e.g., childcare vouchers, gym memberships, health assessments).

Diversity, Inclusion & Workplace Culture

  • ICON values diversity, equity, and inclusion, ensuring an accessible and discrimination-free workplace.

  • Reasonable accommodations are available for applicants with medical conditions or disabilities.


Why Join ICON plc?

  • Work at a world-leading clinical research organization committed to excellence.

  • Opportunities for growth and career advancement in medical writing.

  • Flexible work options (office-based or home-based).


Apply Now

Interested in this role but unsure if you meet all requirements? Apply anyway! ICON values potential and welcomes diverse talent.

Join ICON and contribute to the future of clinical research and medical writing! Apply today!