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Senior Medical Writer

5+ years
Not Disclosed
10 July 21, 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 – 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.