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Senior Medical Writer

7+ years
Not Disclosed
10 Nov. 11, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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

Senior Medical Writer

Location: Bangalore, Bengaluru
Job Code: JR134444
Department: Medical Writing, ICON Full Service & Corporate Support
Work Arrangement: Office or Home


About ICON

ICON plc is a world-leading healthcare intelligence and clinical research organization. We foster an inclusive environment, drive innovation and excellence, and invite you to join us in shaping the future of clinical development.


Role Overview

The Senior Medical Writer will lead the creation and execution of medical writing strategies for clinical trial projects, contributing to the development of innovative treatments and therapies.


Key Responsibilities

  • Lead preparation, review, and editing of clinical study documents including:

    • Clinical study protocols (CSPs)

    • Clinical study reports (CSRs)

    • Investigator brochures (IBs)

    • Patient narratives

    • Regulatory submissions (CTD modules)
      Ensure accuracy, clarity, and compliance with regulatory guidelines and industry standards.

  • Collaborate with cross-functional teams (biostatistics, programming, regulatory affairs, medical affairs) to:

    • Interpret and analyze clinical trial data

    • Summarize scientific findings

    • Communicate key insights effectively in written form

  • Contribute to clinical development planning and execution by providing:

    • Strategic input

    • Scientific expertise to support study design, conduct, and interpretation

  • Mentor and coach junior medical writers on:

    • Best practices

    • Writing techniques

    • Scientific principles

    • Promoting a culture of excellence and continuous learning


Candidate Profile

  • Advanced degree in Life Sciences, Pharmacy, Medicine, or a related field

  • Minimum 7 years of experience in medical writing within pharmaceutical, biotechnology, or CRO sectors

  • Strong skills in:

    • Interpreting and summarizing complex clinical trial data

    • Scientific research analysis and statistical data interpretation

    • Writing, editing, and proofreading scientific documents

  • Solid understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA)

  • Experience interacting with regulatory agencies during review and approval

  • Ability to manage multiple projects in a fast-paced, deadline-driven environment

  • Excellent interpersonal and communication skills to collaborate effectively with cross-functional teams


Benefits at ICON

  • Competitive salary and diverse additional benefits tailored to well-being and work-life balance

  • Examples include:

    • Annual leave entitlements

    • Health insurance for employees and family

    • Retirement planning options

    • Global Employee Assistance Programme (LifeWorks)

    • Life assurance

    • Flexible optional benefits (childcare vouchers, bike purchase schemes, gym discounts, travel subsidies, health assessments)

  • ICON is committed to diversity, inclusion, and accessibility in the workplace. Reasonable accommodations are provided for applicants with disabilities or medical conditions.


Application Note

Even if you do not meet all requirements, ICON encourages you to apply, as your profile may still match current or future opportunities.