LogoFresh Jobs Ahead
Eli Lilly and Company
Eli Lilly and Company
BiotechnologyHealthcarePharmaceuticals
Eli Lilly and Company is a global pharmaceutical and healthcare company developing, manufacturing, and distributing prescription medicines. Its work spans diabetes, cancer, Alzheimer’s disease, autoimmune conditions, dermatology, migraine, obesity, and sleep apnea, supported by clinical research, medication-safety programs, and manufacturing operations. The company also provides patient education, access resources, clinical-trial information, and LillyDirect pharmacy services, while researching areas including genetic medicines.
LinkedIn
Company Jobs

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.

IEIreland
€93,000 – €136,400 / year
HybridFull-timeSeniorEnglish RequiredContent Writer
Google Cloud Platform

Description

  • 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

Requirements

  • 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

Benefits

  • 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

Related Jobs

Anyone AI

AI Agent Evaluator (Argentina, Remote)

Anyone AI
11 – 50 Employees
Artificial IntelligenceEducationRecruitment
ARArgentinaRemotePart-timeMiddleSeniorArabic RequiredGerman RequiredEnglish RequiredSpanish RequiredFrench RequiredHindi RequiredIndonesian RequiredJapanese RequiredKorean RequiredPortuguese RequiredTurkish RequiredArtificial Intelligence

Compare two AI assistants on their use of personal context and connected services. Provide structured feedback to support frontier model training.

Open