Senior Medical Writer

ICON; Canada; On-site; CAD 90,000 - 120,000; Full time

Job summary

A global leader in clinical research, ICON, is seeking a Senior Medical Writer. The role involves leading medical writing activities for regulatory submissions, developing writing strategies, and ensuring compliance. The ideal candidate will have a strong background in medical writing, with at least 5 years of relevant experience. ICON provides a competitive salary and a strong commitment to diversity and inclusion.

Benefits

Health insurance

Retirement plans

Flexible benefits

Work-life balance initiatives

Qualifications

• Minimum 5 years of experience in pharma or biotech medical writing.
• 3+ years handling electronic documents and submissions.
• Experience as lead writer for major regulatory submissions.

Responsibilities

• Lead a team guiding medical writing activities for regulatory submissions.
• Develop writing strategies and oversee document preparation for compliance.
• Manage deliverables and contribute to study designs and analysis plans.

Skills

Strong understanding of clinical development processes

Education

Bachelor’s degree in science, health profession, or journalism

Job description

As a Senior Medical Writer, you will join the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.

What you will be doing:

• Lead a team guiding medical writing activities within a designated therapeutic or functional area for key response documents and regulatory submissions.
• Develop and oversee writing strategies, providing expertise on organization, content, timelines, and resource management.
• Contribute advanced input for study designs, analysis plans, and sections of INDs and marketing applications.
• Coordinate activities with contract employees and vendors, review contributions, and resolve issues.
• Manage deliverables and document preparation for submission to regulatory agencies, ensuring content consistency and regulatory compliance.
• Represent Medical Writing on cross-functional teams and task forces.
• Serve as lead writer for regulatory response documents and key submission components.
• Provide leadership on teams addressing document preparation and production issues.

Qualifications:

• Bachelor’s degree in science, health profession, or journalism.
• Minimum 5 years of experience in pharma or biotech medical writing, including 3+ years handling electronic documents and submissions.
• Experience as lead writer for major US and/or international regulatory submissions.

Knowledge and Skills:

• Strong understanding of clinical development processes from protocol design to regulatory submission and marketed product support.

Additional Information:

ICON offers a competitive salary, diverse benefits focused on well-being and work-life balance, including health insurance, retirement plans, and flexible benefits. We promote an inclusive culture committed to diversity and equal opportunity.