Senior Director, Regulatory Writing & AI Capabilities

Regulatory Jobs; United States; Remote; USD 104,000 - 153,000; Full time

Benefits offered by this job

Healthcare

Pension and life assurance

Travel subsidies

On-site parking

Job summary

Lilly Cork and ExploR&D organizations seek a Senior Director to lead regulatory and medical writing for drug discovery and development, delivering high-quality regulatory and scientific documents. The role oversees business processes, vendor relationships, and IT tools to support multiple development programs, while driving innovation in AI-assisted writing and document standards.

Collaborating with cross-functional teams and external partners, the Senior Director coordinates complex content

Qualifications

• Advanced graduate degree (PharmD, PhD, MD) in health-related or scientific field.
• At least 7 years’ experience in the pharmaceutical industry in two or more areas (preclinical, clinical, CMC, regulatory, regulatory writing).
• Mastery of written English with 3+ years in regulatory, clinical trials documents, or scientific publications.

Responsibilities

• Lead regulatory and medical writing function within ExploR&D.
• Oversee business process management, vendor management, systems management and IT tools for writing needs.
• Coordinate content across complex dossiers ensuring regulatory compliance and clarity.
• Build AI writing capabilities to increase efficiency and manage external partnerships.

Skills

Regulatory writing

Medical writing

Project management

Leadership

AI writing tools

Document management

Education

Advanced graduate degree (PharmD, PhD, MD)

Tools

AI writing tools

Document management systems

Automation tools

Job description

Lilly Cork and ExploR&D organizations seek a Senior Director to lead regulatory and medical writing for drug discovery and development, delivering high-quality regulatory and scientific documents. The role oversees business processes, vendor relationships, and IT tools to support multiple development programs, while driving innovation in AI-assisted writing and document standards.

Collaborating with cross-functional teams and external partners, the Senior Director coordinates complex content