Principal Medical Writer

As a Principal, you will join the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence.

Principal Medical Writer I is responsible for developing clinical documents for regulatory submissions globally. Provides strategic direction to cross-functional project teams with minimal oversight to ensure clinical documents (e.g., Investigators' Brochures [IBs], Clinical Study Reports [CSRs], marketing authorization submission documents) accurately present key data-driven clinical messages according to program goals and regulatory requirements. Writes or directs other writers to ensure timely delivery of high-quality, scientifically rigorous, and well-organized documents with accurate data presentation and interpretation. Oversees medical writing activities across multiple compounds and serves as lead writer for individual summaries. Has a broad understanding of clinical research processes and global regulatory standards.

This is a home-based role dedicated to a global biotech company.

What you will be doing:

• Develop regulatory documents for global submission in accordance with ICH and other guidelines, standards, and client standards, adhering to study timelines and corporate objectives.
• Manage medical writing projects, including developing timelines and coordinating with cross-functional teams to ensure review cycles and expectations are met.
• Participate in meetings to provide input on deliverables, timelines, and processes for regulatory documents.
• Review related documents such as Protocols and Statistical Analysis Plans as appropriate.

You are:

• Bachelor's degree required; advanced degree preferred.
• At least 5 years of medical writing experience in the biopharmaceutical/CRO industry or comparable clinical/preclinical experience.
• Oncology experience is preferred.
• Proficiency in organizing and communicating clinical information with minimal oversight.
• Strong organizational, time management, and project management skills.
• Excellent verbal, written, and interpersonal communication skills for effective teamwork.

What ICON can offer you:

Our success depends on the quality of our people. We prioritize a diverse culture that rewards high performance and nurtures talent.

In addition to a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:

• Annual leave entitlements
• Health insurance options
• Retirement planning
• Global Employee Assistance Programme, TELUS Health, providing 24/7 support
• Life assurance
• Flexible benefits such as childcare vouchers, gym memberships, travel passes, and health assessments

Visit our careers website for more: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental. We are committed to a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. If you need a reasonable accommodation during the application or employment process, please let us know at https://careers.iconplc.com/reasonable-accommodations.

Interested but unsure if you meet all requirements? We encourage you to apply — you might be exactly what we’re looking for.