Senior Medical Writer

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5+ years

Not Disclosed

Japan

10 May 17, 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

Senior Medical Writer
Location: Japan
Job Reference: 2025-118179
Department: Medical Writing – ICON Strategic Solutions (Remote)

About ICON:
ICON plc is the world’s largest and most comprehensive clinical research organization, powered by advanced healthcare intelligence. We pride ourselves on driving innovation and providing our people with opportunities to thrive in a collaborative and inclusive environment.

Position Overview:
As a Senior Medical Writer, you will be responsible for authoring and managing the preparation of a wide range of clinical and regulatory documents in support of new biologic, drug, or medical device development. You will play a central role in clinical submission projects and may lead or mentor other writers while collaborating with clients and internal stakeholders across the globe.

Key Responsibilities:

Write, edit, and compile high-quality submission documents across all phases of drug/device development.
Collaborate closely with clients and subject matter experts to gather data and ensure alignment with regulatory and project requirements.
Guide and oversee the work of other medical writers as needed to meet project deliverables.
Serve as a key contact for client-facing interactions, ensuring quality and consistency across document deliverables.
Ensure compliance with applicable regulatory guidelines and internal quality standards.

Candidate Profile:

Minimum 5 years of experience in preparing submission documents during the development phase.
Strong experience with global submission projects.
University degree in a science or health-related field.
Fluent in written and spoken English.
Demonstrated experience in client-facing roles and cross-functional team collaboration.

What ICON Offers:

Competitive salary and performance-based incentives.
Generous annual leave entitlements.
Comprehensive health insurance options tailored to your and your family's needs.
Retirement planning support to help you plan confidently for the future.
Access to TELUS Health Global Employee Assistance Programme offering 24/7 mental health and well-being support.
Life assurance and a suite of country-specific optional benefits including gym discounts, travel passes, childcare vouchers, and more.

Diversity & Inclusion:
ICON is committed to fostering a workplace that embraces diversity and inclusion. We provide a supportive and accessible environment for all candidates and employees. Discrimination or harassment of any kind is not tolerated.

Need accommodations?
If you require a reasonable accommodation due to a medical condition or disability, please notify us using the link below:
Request an accommodation

Not sure you meet all the criteria?
We still encourage you to apply — you may be the perfect fit for this or another opportunity at ICON.

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