Principal Medical Writer

As a Principal Medical Writer, you will be dedicated to one of our pharmaceutical clients with a truly global presence; this unique industry-changing partnership redefines collaboration. The program is ideal for individuals who thrive in a continually-evolving culture that mirrors ICON's commitment to career development.

• Guides medical writing document preparation, including coordination of assignments to writers, review, and substantive editing of documents.
• May assume primary responsibility for preparation of key regulatory response documents and documents supporting major regulatory submission.
• Formulates writing approach, develops timelines, and assesses resource requirements for key documents and regulatory submissions within designated therapeutic or functional area.
• Participates on relevant project teams and task forces, providing functional and cross-functional guidance on document preparation, including international regulatory guidance and requirements.
• 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.
• Provides review and substantive editing of contributions, ensuring resolution of issues.
• Manages deliverables and preparation of documents for submission to regulatory agencies, ensuring consistency of content within therapeutic areas and adherence to regulatory requirements.
• Represents Medical Writing on cross-functional teams and task forces.
• Acts as a key Medical Point of contact for clinical regulatory strategy.
• Serves as lead writer for important regulatory response documents and key components of regulatory submissions.
• Provides leadership on functional teams addressing document preparation and production requirements.
• Performs work independently with minimal supervision.

• Bachelor's degree in science or health profession required.
• At least 7 years of 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 international regulatory submissions required.
• Experience managing writing activities for a major international regulatory submission preferred.

• Clear understanding of clinical development, including phases, processes, and techniques used from protocol design through regulatory submission.
• Understanding of international regulations, ICH guidelines, and applicable international regulatory processes related to document preparation.
• Well-developed oral and written communication skills; ability to present technical information within and across functional areas.
• Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within functional and cross-functional teams.

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 designed to be competitive within each country and 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.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of professionals.
• Life assurance.
• Flexible country-specific optional benefits.

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates and committed to providing a workplace free of discrimination and harassment.