Principal Medical Writer

As a Principal Medical Writer, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

• Leads a single team which guides medical writing activities within a designated therapeutic or functional area for key response documents and regulatory submissions.
• Leads the writing strategy providing expertise including organization, content, timelines, and resource requirements.
• Provides more complex advanced input for study designs, analysis plans, sections of INDs and marketing applications.
• Coordinates the activities, contract employees and vendors (on-site or external), provides review and substantive editing of contributions, and ensures resolution of issues.
• Within designated therapeutic or compound function, manages deliverables and preparation of documents for submission to FDA or other regulatory agencies, ensuring consistency of content within therapeutic areas and adherence to regulatory requirements and processes across development programs.
• Represents Medical Writing on cross-functional teams and task forces (related to projects, process, and standards).
• As required, serves as lead writer for important regulatory response documents and key components of regulatory submissions.
• Provides leadership on functional teams that address requirements or issues related to document preparation and production.

• Bachelor's degree in science, health profession, or journalism required.
• At least 5 plus years experience writing for pharma or biotechnology required. 3+ years of electronic documents and submissions required.
• Experience as lead writer for key documents included in major US and/or international regulatory submissions required.
• Experience managing writing activities for a major US or international regulatory submission (project or people management) preferred.

• Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed product.

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work-life balance opportunities for you and your family.

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family's needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates.