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Eli Lilly and Company
Eli Lilly and Company
Asistență medicalăBiotehnologieProduse farmaceutice
Eli Lilly and Company este o companie globală din domeniul farmaceutic și al asistenței medicale, care dezvoltă, produce și distribuie medicamente eliberate pe bază de rețetă. Activitatea sa acoperă diabetul, cancerul, boala Alzheimer, afecțiunile autoimune, dermatologia, migrena, obezitatea și apneea în somn, fiind susținută de cercetare clinică, programe de siguranță a medicamentelor și operațiuni de producție. Compania oferă, de asemenea, educație pentru pacienți, resurse pentru accesarea serviciilor medicale, informații despre studiile clinice și servicii de farmacie LillyDirect, cercetând în același timp domenii precum medicamentele genetice.
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Locurile de muncă ale companiei

Senior Director, ExploR&D Regulatory Writing and Capabilities — Cork, Ireland (Hybrid)

Lead regulatory and medical writing for Lilly ExploR&D’s biotech drug-development partnerships in Cork. Build AI-enabled writing capabilities, oversee vendors, and deliver clinical and regulatory documents.

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

Descriere

  • Lead the regulatory and medical writing function within ExploR&D
  • Oversee the preparation and delivery of clinical and regulatory documents
  • Develop IT tools that support document-writing needs for ExploR&D and its partners
  • Manage business processes, vendors, systems, implementations, and emerging technologies
  • Provide strategic, tactical, technical, and operational direction across the ExploR&D portfolio
  • Lead writing deliverables and associated 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 schedule
  • Monitor workloads and escalate resource-capacity concerns
  • Plan, write, edit, review, and strategically coordinate regulatory documents, development strategies, and scientific publications
  • Oversee quality review and document finalization
  • Provide expertise in databases and document-management tools
  • Represent ExploR&D on assigned projects and engage with biotech partners
  • Build and manage relationships with biotech partners and vendors
  • Support the identification, prioritization, and assessment of collaboration opportunities
  • Maintain knowledge of regulatory and publication guidelines and share best practices across Lilly
  • Develop AI writing capabilities and implement tools including AI authoring, automation, and document-management systems
  • 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

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 two or more areas: preclinical development including PK/PD, pharmacology, or toxicology; clinical development; CMC; regulatory affairs; or regulatory writing
  • At least three years of experience writing regulatory documents, clinical trial documents, and/or scientific publications
  • Mastery of written English
  • Experience with clinical trial processes and/or regulatory activities
  • Deep understanding of investigational product requirements, particularly GCP and GLP regulations
  • Experience leading document development across multiple document types and indications
  • Experience managing external partnerships and vendor relationships
  • Strong critical-thinking, strategy-development, and decision-making abilities
  • Ability to influence strategy and deliver results in complex or ambiguous environments
  • Project-management and time-management skills
  • Leadership and team-management capabilities
  • Strong interpersonal skills and flexibility across varied environments and customer groups
  • Advanced end-user computer skills, including word processing, tables and graphics, spreadsheets, presentations, and templates
  • Experience using, developing, or implementing automation tools and software solutions, including AI-driven tools
  • Ability to collaborate effectively across cultures and time zones
  • Relocation is not provided
  • A writing exercise may be required, and writing samples may be requested

Beneficii

  • Flexible hybrid working options
  • Healthcare benefits
  • Pension plan and pension benefits
  • Life assurance and life insurance or death benefits
  • Subsidised canteen
  • Onsite gym and fitness benefits
  • Travel subsidies
  • On-site parking
  • In-house People Development services
  • Educational assistance
  • ‘Live Your BEST Life’ wellbeing initiatives
  • Employee assistance program
  • Employee clubs and activities
  • Vacation benefits
  • Flexible benefits
  • Certain time-off and leave-of-absence benefits
  • Eligibility for a company bonus based on company and individual performance

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