Senior Medical Writer

ICON; Canada; Remote; CAD 80,000 - 120,000; Full time

Job summary

ICON, a leading clinical research organization, seeks a Senior Medical Writer to lead medical writing activities for regulatory submissions. The role requires extensive experience in pharmaceutical writing and offers competitive salaries and benefits focused on well-being and work-life balance.

Benefits

Competitive salaries

Health insurance

Retirement plans

Various leave entitlements

Work-life balance initiatives

Qualifications

• Minimum 5 years of experience in pharmaceutical or biotech writing.
• At least 3 years in electronic document submissions.
• Experience managing writing activities for major regulatory submissions preferred.

Responsibilities

• Leads a team guiding medical writing activities for regulatory submissions.
• Develops writing strategies and ensures content consistency.
• Serves as lead writer for regulatory response documents.

Skills

Leadership

Regulatory Compliance

Clinical Development Knowledge

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:

• Leads a team guiding medical writing activities within a designated therapeutic or functional area for key response documents and regulatory submissions.
• Develops writing strategies, providing expertise on organization, content, timelines, and resource requirements.
• Provides complex input for study designs, analysis plans, and sections of INDs and marketing applications.
• Coordinates activities with contract employees and vendors, reviews contributions, and resolves issues.
• Manages deliverables and document preparation for submission to regulatory agencies, ensuring content consistency and regulatory compliance within therapeutic areas.
• Represents Medical Writing on cross-functional teams and task forces.
• Serves as lead writer for regulatory response documents and key submission components.
• Provides leadership on teams addressing document preparation and production issues.

You are:

• Bachelor’s degree in science, health profession, or journalism.
• Minimum 5 years of experience in pharmaceutical or biotech writing; at least 3 years in electronic document submissions.
• Experience as lead writer for major regulatory documents in US and/or international submissions.
• Experience managing writing activities for major regulatory submissions is preferred.

Knowledge and Skills:

• Understanding of clinical development phases, processes, and techniques from protocol design to regulatory submission and marketed product support.

What ICON can offer you:

Our success depends on our people. We prioritize diversity, high performance, and talent development. We offer competitive salaries and benefits focused on well-being and work-life balance, including various leave entitlements, health insurance, retirement plans, and additional perks.