Senior Principal Medical Writer

Overview

ICON Strategic Solutions is a global leader in healthcare intelligence and clinical research. As the Senior Principal Medical Writer, you will lead the development of high-quality clinical and regulatory documents, ensuring clarity, accuracy, and compliance with industry standards.

Responsibilities

You will be responsible for:

• Developing and authoring clinical study reports, protocols, investigator brochures, and regulatory submissions.
• Ensuring documents comply with regulatory guidelines and company quality standards.
• Collaborating with clinical operations, biostatistics, and regulatory affairs teams to interpret clinical data.
• Mentoring junior medical writers and reviewing documents for consistency.
• Staying updated with industry trends and contributing to process improvements.

Qualifications

Required qualifications include:

• A master’s degree or Ph.D. in Life Sciences, Medicine, or related field.
• Extensive experience in developing clinical and regulatory documents within the pharmaceutical/biotech industry.
• Strong scientific writing, editing, and analytical skills.
• Demonstrated leadership and mentoring capabilities.
• Excellent communication and organizational skills.

Benefits

ICON offers competitive compensation along with benefits including:

• Generous annual leave entitlements.
• Comprehensive health insurance options.
• Retirement planning programs.
• Global Employee Assistance Programme.
• Flexible country-specific benefits.

Inclusivity & Application Process

At ICON, inclusion and belonging are fundamental. All qualified applicants will receive equal consideration. If you require accommodations during the application process, please let us know.

Key skills/competency

Medical Writing, Regulatory, Clinical, Research, Editing, Mentorship, Compliance, Leadership, Documentation, Analysis