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Eli Lilly and Company
Eli Lilly and Company
Asistență medicalăBiotehnologieProduse farmaceutice
Eli Lilly and Company este o companie multinațională farmaceutică și de asistență medicală, axată pe descoperirea, dezvoltarea, fabricarea și comercializarea medicamentelor eliberate pe bază de prescripție medicală. Activitatea sa acoperă domenii terapeutice precum diabetul, oncologia, imunologia, neuroștiința și durerea, combinând cercetarea și dezvoltarea cu studiile clinice, procesele de reglementare, producția de medicamente biologice și cu molecule mici, precum și distribuția globală.
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Senior Director, Regulatory Writing and Capabilities — ExploR&D, Cork Hybrid

Lead regulatory and medical writing for Eli Lilly’s ExploR&D organization in a senior leadership role. Develop AI-enabled writing tools and capabilities that support biotech partners and medicine development.

IEIrlanda
93.000 € – 136.400 € / an
HibridNormă întreagăSeniorLimbă Obligatorie: englezăRedactor de conținut
Google Cloud Platform

Descriere

  • Direct the regulatory and medical writing function within ExploR&D
  • Oversee the preparation and delivery of clinical and regulatory documentation
  • Develop IT tools that support document-writing needs for ExploR&D and its partners
  • Set strategic, tactical, technical, and operational direction across the ExploR&D portfolio
  • Own writing deliverables and associated strategies
  • Partner with internal and external multidisciplinary teams to produce regulatory and scientific documents
  • Coordinate content across complex documents to maintain accuracy, compliance, and clarity
  • Prepare and manage protocols, investigator brochures, clinical study reports, briefing documents, regulatory responses, Target Product Profiles, regulatory strategy documents, Integrated Development Plans, IND/CTA materials, abstracts, posters, manuscripts, and presentations
  • Lead cross-functional teams and maintain delivery of writing commitments on schedule
  • Manage workloads and escalate resource-capacity constraints
  • Plan, draft, edit, review, coordinate, quality-check, and finalize documents
  • Provide expertise in databases and document management systems
  • Represent ExploR&D on assigned projects and engage with biotech partners
  • Develop and manage relationships with biotech partners and vendors
  • Advise on medical writing activities and asset development
  • Identify and evaluate potential collaboration opportunities
  • Maintain knowledge of regulatory and publication guidelines and share best practices
  • Build AI writing capabilities and implement systems, automation, AI authoring tools, and document management solutions
  • Allocate medical writing resources and establish document standards, workflows, priorities, SOPs, and templates
  • Coach, mentor, and train staff and cross-functional colleagues
  • Recruit, develop, and retain medical writing personnel when assigned
  • Promote quality, safety, inclusion, innovation, and sound judgment in decision-making

Cerințe

  • Advanced graduate degree such as a PharmD, PhD, or MD in a health-related or scientific discipline
  • At least seven years of pharmaceutical-industry experience spanning at least two areas, including preclinical development, clinical development, CMC, regulatory affairs, or regulatory writing
  • Exceptional written English and at least three years of experience producing regulatory, clinical-trial, or scientific publication content
  • Experience with clinical-trial processes and/or regulatory activities
  • Thorough knowledge of investigational-product requirements, particularly GCP and GLP regulations
  • Proven leadership in managing document development across multiple document types or indications
  • Experience managing external partnerships and vendor relationships
  • Strong critical-thinking, strategic-planning, and decision-making abilities
  • Ability to influence strategy and deliver outcomes in complex or ambiguous settings
  • Effective project-management and time-management skills
  • Strong leadership and people-management capabilities
  • Excellent interpersonal skills and adaptability across environments and customer groups
  • Advanced end-user computer skills covering word processing, tables and graphics, spreadsheets, presentations, and templates
  • Experience using, developing, or implementing automation and software solutions, including AI-enabled tools
  • Ability to collaborate effectively across cultures and time zones
  • Direct-supervision or cross-functional team leadership experience is preferred
  • Willingness and ability to travel up to 10% within the US and/or internationally
  • Relocation support is not provided
  • A writing exercise may be required, and writing samples may be requested

Beneficii

  • Flexible hybrid work arrangements
  • Healthcare benefits
  • Pension plan
  • Life assurance, life insurance, and death benefits
  • Subsidized canteen
  • On-site gym and fitness benefits
  • Travel subsidies
  • On-site parking
  • Internal people-development services
  • Educational assistance
  • Wellbeing initiatives
  • Employee assistance program
  • Employee clubs and activities
  • Vacation benefits
  • Eligible time-off and leave-of-absence benefits
  • Eligibility for a company bonus based on company and individual performance
  • Quarterly travel to Indianapolis for remote US employees
  • Flexible benefits where applicable

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