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Eli Lilly and Company
Eli Lilly and Company
BiotexnologiyaFarmatsevtika mahsulotlariSog‘liqni saqlash
Eli Lilly and Company retsept bo‘yicha beriladigan dori vositalarini ishlab chiqadigan, ishlab chiqaradigan va tarqatadigan global farmatsevtika hamda sog‘liqni saqlash kompaniyasidir. Uning faoliyati diabet, saraton, Altsgeymer kasalligi, autoimmun kasalliklar, dermatologiya, migren, semirish va uyqu apnesi yo‘nalishlarini qamrab oladi. Bu ishlar klinik tadqiqotlar, dori xavfsizligi dasturlari va ishlab chiqarish operatsiyalari bilan qo‘llab-quvvatlanadi. Kompaniya bemorlarga ta’lim berish, dori vositalaridan foydalanish resurslari, klinik sinovlar haqidagi ma’lumotlar va LillyDirect dorixona xizmatlarini ham taqdim etadi hamda genetik dori vositalari kabi yo‘nalishlarda tadqiqot olib boradi.
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Kompaniyadagi ish o‘rinlari

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.

IEIrlandiya
93 000 € – 136 400 € / yil
GibridTo‘liq stavkaSeniorTalab Qilinadigan Til: inglizchaKontent yozuvchisi
Google Cloud Platform

Tavsif

  • 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

Talablar

  • 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

Imtiyozlar

  • 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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