Senior Director of Regulatory Writing & AI Capabilities

527 Eli Lilly Cork Limited; Cork; Remote; EUR 93,000 - 136,000; Full time

Benefits offered by this job

Pension and life assurance

Subsidised canteen

Onsite gym

Travel subsidies

On-site parking

Educational assistance

Wellbeing programs

Job summary

Lilly UK & Ireland is seeking a Senior Director to lead the regulatory and medical writing function within ExploR&D. The role oversees document preparation, vendor management, systems implementation, and strategic direction across preclinical, clinical, and regulatory documents for global interactions.

Responsibilities include coordinating content across complex documents, ensuring accuracy and compliance, and building AI-enabled writing capabilities.

Qualifications

• Advanced degree in health-related or scientific field required.
• Minimum 7 years in pharmaceutical regulatory writing or related areas.
• Experience coordinating across cross-functional teams and vendors.

Responsibilities

• Lead regulatory and medical writing across ExploR&D portfolio.
• Coordinate development and delivery of regulatory documents and publications.
• Oversee vendor management, systems, and process improvements.
• Build and manage AI-assisted writing capabilities and tools.

Skills

Regulatory writing

Project management

Leadership

Cross-functional collaboration

Regulatory affairs

Education

Advanced graduate degree (PharmD/PhD/MD)

Tools

AI writing tools

Document management systems

Regulatory writing software

Job description

Lilly UK & Ireland is seeking a Senior Director to lead the regulatory and medical writing function within ExploR&D. The role oversees document preparation, vendor management, systems implementation, and strategic direction across preclinical, clinical, and regulatory documents for global interactions.

Responsibilities include coordinating content across complex documents, ensuring accuracy and compliance, and building AI-enabled writing capabilities.