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.
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