Senior Medical Writer – Canada (Remote) | ICON Strategic Solutions
Join ICON Strategic Solutions, the world’s largest and most comprehensive clinical research organisation, as a Senior Medical Writer. This is a remote role based in Canada, where you’ll be at the forefront of guiding critical regulatory documentation in global drug development projects. Leverage your expertise in clinical writing to lead submissions to regulatory authorities such as the FDA and international bodies.
Key Responsibilities:
Lead medical writing for key regulatory submissions and response documents
Drive writing strategies for clinical documents including INDs, marketing applications, and analysis plans
Manage cross-functional teams, external vendors, and writing deliverables
Provide senior-level input into study designs and document content
Ensure regulatory compliance and consistency across therapeutic areas
Represent Medical Writing in cross-functional project and process teams
Serve as lead writer on important regulatory documents
Required Skills & Qualifications:
Bachelor’s degree in Science, Health Professions, or Journalism
Minimum 5+ years of medical writing experience in pharma or biotech
At least 3 years working with electronic submissions and documents
Proven experience as lead writer for major US/international regulatory submissions
Experience managing writing projects or teams is preferred
Strong understanding of clinical development processes and regulatory requirements
Expertise in tools and standards such as MedDRA, GVP, ICH-GCP, and submission systems
Perks & Benefits:
Competitive salary package
Flexible working arrangements (remote)
Generous annual leave entitlements
Comprehensive health insurance for you and your family
Retirement planning and savings support
Global Employee Assistance Programme access
Life assurance and optional benefits like gym memberships, travel passes, and more
Company Overview:
ICON plc is a global healthcare intelligence and clinical research organisation. With operations in over 40 countries, ICON partners with pharmaceutical, biotech, and medical device companies to accelerate development and bring new therapies to patients faster. The company is committed to inclusion, innovation, and fostering professional growth.
Work Mode:
Remote – Canada
Call to Action:
Ready to lead global medical writing initiatives and make a lasting impact on drug development? Apply now to join ICON as a Senior Medical Writer and take your clinical writing career to the next level.
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