Sr. Director - ExploR&D Regulatory Writing and Capabilities

Lilly • Indianapolis, IN

6d • €93,000 - €136,400 • Hybrid

About The Position

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, and 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, and 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), and external scientific publications (such as abstracts, posters, manuscripts, and presentations).

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• Lead cross-functional teams to ensure timely development of writing deliverables
• Manage and track workload; escalate resource capacity issues as needed
• Plan, write, edit, review, and strategically coordinate complex regulatory documents, development strategies, and scientific publications
• Oversee and coordinate quality review and finalization of documents
• Provide expertise on databases and other tools necessary to perform work (such as document management systems)
• Represent ExploR&D in assigned projects, interacting directly with biotech partners
• Strategically build and manage relationships with biotech partners and vendors
• Serve as an expert for ExploR&D portfolio and associated asset development, as it pertains to medical writing activities and related expertise
• Contribute to the identification, prioritization, and assessment of collaboration opportunities
• Maintain and enhance knowledge of regulatory and publication guidelines
• Network with Lilly functions to share best practices
• Build a suite of AI writing capabilities to increase efficiency within ExploR&D, working with internal experts and external vendors
• Identify, evaluate, develop, and implement systems and tools that increase efficiency and streamline document development, such as AI Authoring tools, automation tools and document management systems
• Allocate medical writing resources to support incoming projects
• Support ExploR&D’s strategic direction by implementing document standards, workflows, and priorities in support of the portfolio
• Identify and implement improvements in writing processes, standard operating procedures (SOPs), and templates to ensure they are fit for purpose
• Provide informal coaching to others by sharing technical information, giving guidance, and answering questions
• Support cross-functional coaching, mentoring, and training
• Train, coach, and mentor staff to deepen their medical writing expertise, improve communication skills, and build strong relationships across ExploR&D functions and with external partners (this may be through direct or indirect reporting relationships, as assigned)
• If assigned, recruit, develop, and retain an operationally capable workforce skilled in medical writing and its application in clinical development
• Champion a commitment to quality and safety
• Support a culture that fosters inclusion, innovation, and judgement-based decision making

Benefits

• flexible hybrid working options
• healthcare
• pension
• 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 bonus
• pension plan
• vacation benefits
• healthcare benefits
• flexible benefits
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Director