Senior Director, Regulatory & Medical Writing

Eli Lilly and Company; Indianapolis (IN); Remote; USD 104,000 - 153,000; Full time

Benefits offered by this job

Pension plan

Life insurance

Subsidised canteen

Onsite gym

Travel subsidies

On-site parking

Educational assistance

Wellbeing programs

Job summary

Lilly is seeking a Senior Director to lead regulatory and medical writing within ExploR&D, overseeing the preparation and delivery of clinical and regulatory documents and the development of IT tools to support document writing needs. The role drives business process management, vendor management, systems management, and strategy across the ExploR&D portfolio.

The Senior Director collaborates with cross-functional teams to deliver high-quality documents for regulatory interactions, clinical

Qualifications

• Minimum 7 years in pharma with regulatory writing experience.
• Advanced graduate degree required in health/science field.
• Experience leading cross-functional teams and external partnerships.

Responsibilities

• Lead regulatory and medical writing across ExploR&D portfolio.
• Coordinate content for protocols, briefs, reports and publications.
• Manage vendors, processes, and emerging tech for writing workflows.
• Ensure quality and compliance across documents for regulatory submissions.

Skills

Regulatory writing

Leadership

Cross-functional leadership

Project management

Strategic thinking

Vendor management

AI writing tools

Team development

Education

Advanced graduate degree (PharmD, PhD, MD)

Tools

Document management systems

AI writing tools

Job description

Lilly is seeking a Senior Director to lead regulatory and medical writing within ExploR&D, overseeing the preparation and delivery of clinical and regulatory documents and the development of IT tools to support document writing needs. The role drives business process management, vendor management, systems management, and strategy across the ExploR&D portfolio.

The Senior Director collaborates with cross-functional teams to deliver high-quality documents for regulatory interactions, clinical