Senior Director, Regulatory Writing & Strategy

Eli Lilly and Company; San Francisco (CA); Remote; USD 100,000 - 146,000; Full time

Benefits offered by this job

Pension plan

Healthcare benefits

Educational assistance

Job summary

Lilly Catalyze360 in the Bay Area, Cork, and Indy locations seeks a Senior Director to lead regulatory and medical writing across ExploR&D. You will oversee document preparation, manage systems, vendor relationships, and implement AI writing tools to accelerate regulatory strategies.

Collaborate with cross-functional teams, ensure compliance, and guide content from preclinical through external publications.

Qualifications

• Advanced degree in health-related or scientific field.
• 7+ years in pharmaceutical industry across regulatory writing and related areas.

Responsibilities

• Lead cross-functional teams to ensure timely writing deliverables.
• Manage workload and resource capacity.
• Coordinate complex regulatory documents and publications.
• Oversee quality review and finalization of documents.
• Develop and implement AI writing capabilities.

Skills

Regulatory writing

Project management

Leadership

Cross-functional collaboration

AI writing tools

Vendor management

Education

Advanced degree in health-related or scientific field

Tools

Document management systems

AI-driven tools

Automation tools

Job description

Lilly Catalyze360 in the Bay Area, Cork, and Indy locations seeks a Senior Director to lead regulatory and medical writing across ExploR&D. You will oversee document preparation, manage systems, vendor relationships, and implement AI writing tools to accelerate regulatory strategies.

Collaborate with cross-functional teams, ensure compliance, and guide content from preclinical through external publications.