Senior Medical Writer (Level 2) - Regulatory Documents

About the role

ICON, a global healthcare intelligence and clinical research organisation, is looking for a Senior, Principal or Level 2 Medical Writer to lead the development of high-quality regulatory and clinical documents. The role supports clients' submissions to regulatory authorities and ensures compliance with industry standards. The position is advertised as #LI-Remote.

Key responsibilities

• Guide medical writing document preparation, coordinate assignments to writers, and review and edit documents substantively.
• Assume primary responsibility for key regulatory response documents and documents supporting major regulatory submissions when needed.
• Formulate writing approaches, develop timelines and assess resource requirements for documents and submissions within a therapeutic or functional area.
• Lead the writing strategy, including organisation, content, timelines and resource needs.
• Provide advanced input for study designs, analysis plans and sections of INDs and marketing applications.
• Manage deliverables and document preparation for regulatory agency submissions, ensuring consistency across therapeutic areas and adherence to regulatory and sponsor requirements.
• Represent Medical Writing on cross-functional teams and act as a key point of contact for clinical regulatory strategy.
• Serve as lead writer for important regulatory response documents and key parts of regulatory submissions, and provide leadership on functional teams.

Required profile

• Bachelor's degree in science or health profession required.
• At least 3 years of experience writing for pharma or biotechnology preferred; 3+ years of electronic documents and submissions required.
• Experience writing key documents such as clinical study reports, IBs and protocols.
• Legal right to work in the country where the role is based.

Required skills

• Clear understanding of clinical development, from protocol design through regulatory submission and support of marketed products.
• Understanding of international regulations, ICH guidelines and CTDs.
• Well-developed oral and written communication skills and problem-solving abilities.

What we offer

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes, including medical, dental and vision coverage where applicable.
• Retirement and pension plans, life assurance and disability coverage.
• Employee assistance programmes and learning and development opportunities.