[Hiring] Senior Director - ExploR&D Regulatory Writing and Capabilities @Lilly

Role Description

The Senior Director will lead the regulatory and medical writing function within ExploR&D, overseeing the preparation and delivery of clinical and regulatory documents and development of IT tools to support the document writing needs of ExploR&D and our partners. The Senior Director will be responsible for:

• Business process management
• Vendor management
• Systems management
• Systems implementation
• Emerging technology implementation

The Senior Director will provide strategic, tactical, and technical/operational direction, and lead writing deliverables and strategies across the ExploR&D portfolio.

The Senior Director collaborates with cross-functional, multidisciplinary teams, including internal and external stakeholders, to produce high-quality regulatory and scientific documents intended to support:

• Regulatory interactions
• Clinical trial execution
• External partner’s strategies

The Senior Director is responsible for coordinating content across complex documents, ensuring accuracy, compliance, and clarity. These documents may include:

• Preclinical, clinical and regulatory documents (such as protocols, investigator’s brochures, clinical study reports, briefing documents, regulatory responses, Target Product Profiles, regulatory strategy documents, and Integrated Development Plans)
• Global clinical trial applications (IND/CTA documents)
• External scientific publications (such as abstracts, posters, manuscripts, and presentations)

Qualifications

• Advanced graduate degree (PharmD, PhD, MD) in a health-related or scientific field
• At least 7 years of experience in the pharmaceutical industry in two or more of the following areas: preclinical development (PK/PD, pharmacology, toxicology), clinical development, CMC, regulatory affairs, regulatory writing
• Demonstrated mastery of written English with at least 3 years’ experience in writing regulatory, clinical trial documents, and/or scientific publications

Requirements

• Experience in clinical trial process and/or regulatory activities
• Deep understanding of investigational product requirements, especially GCP and GLP regulations
• Demonstrated leadership in managing document development for various document types/indications
• Experience in managing external partnerships/vendor relationships
• Exceptional critical thinking, strategy development, and decision-making skills
• Demonstrated ability to influence strategies and proven ability to deliver results in a complex or ambiguous environment
• Demonstrated project management and time management skills
• Demonstrated strong leadership and team management skills
• Experience as a direct supervisor or leading cross-functional teams preferred
• Strong interpersonal skills and the ability to be flexible in varying environments and with multiple customer groups
• Demonstrated high-level end-user computer skills (such as word processing, working with tables and graphics, spreadsheets, presentation and templates)
• Experience in use, development or implementation of automation tools and software solutions, including AI-driven tools to streamline document creation and development process
• Ability to work well across cultures and time zones

Benefits

• Healthcare benefits
• Pension and life assurance benefits
• Subsidised canteen
• Onsite gym
• Travel subsidies
• On-site parking
• Inhouse People Development services
• Educational Assistance
• ‘Live Your BEST Life’ wellbeing initiatives

Company Description

Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.

Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!