Eli Lilly and Company
Eli Lilly and Company
Eli Lilly and Company एक वैश्विक दवा और स्वास्थ्य सेवा कंपनी है, जो प्रिस्क्रिप्शन दवाओं का विकास, निर्माण और वितरण करती है। इसका कार्य मधुमेह, कैंसर, अल्ज़ाइमर रोग, ऑटोइम्यून स्थितियों, त्वचाविज्ञान, माइग्रेन, मोटापे और स्लीप एपनिया जैसे क्षेत्रों तक फैला है तथा इसे क्लिनिकल अनुसंधान, दवा-सुरक्षा कार्यक्रमों और विनिर्माण परिचालनों का समर्थन प्राप्त है। कंपनी रोगी शिक्षा, उपचार तक पहुंच से जुड़े संसाधन, क्लिनिकल ट्रायल की जानकारी और LillyDirect फार्मेसी सेवाएं भी प्रदान करती है, साथ ही आनुवंशिक दवाओं सहित अन्य क्षेत्रों में अनुसंधान करती है।

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.

विवरण

  • 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

आवश्यकताएँ

  • 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

लाभ

  • 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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