Content Writer

• Lead the regulatory and medical writing function within ExploR&D
• Oversee preparation and delivery of clinical and regulatory documents
• Develop IT tools supporting document-writing needs for ExploR&D and partners
• Manage business processes, vendors, systems, system implementation, and emerging technology implementation
• Provide strategic, tactical, technical, and operational direction across the ExploR&D portfolio
• Lead writing deliverables and strategies
• Collaborate with internal and external multidisciplinary stakeholders
• Coordinate content across complex preclinical, clinical, regulatory, and scientific documents
• Lead cross-functional teams to deliver writing outputs on time
• Manage and track workload and escalate resource-capacity issues
• Plan, write, edit, review, and strategically coordinate regulatory documents, development strategies, and scientific publications
• Oversee quality review and document finalization
• Provide expertise on databases and document-management tools
• Represent ExploR&D in assigned projects and interact with biotech partners
• Build and manage relationships with biotech partners and vendors
• Contribute to collaboration opportunity identification, prioritization, and assessment
• Maintain knowledge of regulatory and publication guidelines and share best practices across Lilly
• Build AI writing capabilities and implement systems and tools such as AI authoring, automation, and document-management tools
• Allocate medical-writing resources to incoming projects
• Implement document standards, workflows, priorities, process improvements, SOPs, and templates
• Coach, mentor, train, recruit, develop, and retain medical-writing staff as assigned
• Champion quality, safety, inclusion, innovation, and judgment-based decision-making

Senior Director – ExploR&D Regulatory Writing and Capabilities

• Lead the regulatory and medical writing function within ExploR&D
• Oversee preparation and delivery of clinical and regulatory documents
• Develop IT tools supporting document-writing needs for ExploR&D and partners
• Provide strategic, tactical, technical, and operational direction across the ExploR&D portfolio
• Lead writing deliverables and strategies
• Collaborate with internal and external multidisciplinary stakeholders to produce regulatory and scientific documents
• Coordinate content across complex documents to ensure accuracy, compliance, and clarity
• Prepare and manage protocols, investigator’s brochures, clinical study reports, briefing documents, regulatory responses, Target Product Profiles, regulatory strategy documents, Integrated Development Plans, IND/CTA documents, abstracts, posters, manuscripts, and presentations
• Lead cross-functional teams and ensure timely writing deliverables
• Manage workload and escalate resource capacity issues
• Plan, write, edit, review, strategically coordinate, quality-review, and finalize documents
• Provide expertise on databases and document management systems
• Represent ExploR&D in assigned projects and interact with biotech partners
• Build and manage biotech partner and vendor relationships
• Advise on medical writing activities and asset development
• Identify and assess collaboration opportunities
• Maintain regulatory and publication guideline knowledge and share best practices
• Build AI writing capabilities and implement systems, automation tools, AI authoring tools, and document management systems
• Allocate medical writing resources and implement document standards, workflows, priorities, SOPs, and templates
• Coach, mentor, and train staff and cross-functional colleagues
• Recruit, develop, and retain medical writing staff if assigned
• Champion quality, safety, inclusion, innovation, and judgment-based decision-making