Senior Director, Regulatory Writing & Strategy

Eli Lilly and Company; Cork; Ibrido; EUR 93.000 - 136.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension plan

Healthcare benefits

Vacation benefits

Wellbeing programs

Descrizione del lavoro

Lilly Cork is seeking a Senior Director to lead regulatory and medical writing within ExploR&D, overseeing preparation of clinical and regulatory documents and development of IT tools to support writing needs. You will manage business processes, vendor relationships, systems, and strategic writing deliverables across the portfolio.

You will collaborate with cross-functional teams across multiple sites to ensure regulatory compliance and publication quality, coordinating content across documents

Competenze

• At least 7 years in the pharmaceutical industry with regulatory writing experience.
• Advanced degree in health-related field.
• Proven leadership of cross-functional teams.
• Experience with regulatory submissions and publications.

Mansioni

• Lead and coordinate writing deliverables for regulatory documents and publications.
• Oversee vendor management and strategic partnerships.
• Develop and implement AI-driven writing capabilities.
• Manage processes, SOPs, and quality review.
• Mentor staff and manage resources.

Conoscenze

Regulatory writing

Project management

Leadership

Cross-functional collaboration

Regulatory affairs

Formazione

Advanced degree in health field (PharmD/PhD/MD)

Strumenti

AI writing tools

Document management systems

Regulatory databases

Descrizione del lavoro

Lilly Cork is seeking a Senior Director to lead regulatory and medical writing within ExploR&D, overseeing preparation of clinical and regulatory documents and development of IT tools to support writing needs. You will manage business processes, vendor relationships, systems, and strategic writing deliverables across the portfolio.

You will collaborate with cross-functional teams across multiple sites to ensure regulatory compliance and publication quality, coordinating content across documents