Eli Lilly and Company
Eli Lilly and Company
Eli Lilly and Company — рецептімен берілетін дәрі-дәрмектерді ашуға, әзірлеуге, өндіруге және нарыққа шығаруға бағытталған көпұлтты фармацевтикалық және денсаулық сақтау компаниясы. Оның қызметі қант диабеті, онкология, иммунология, неврология және ауырсыну сияқты терапиялық бағыттарды қамтиды. Компания зерттеулер мен әзірлемелерді клиникалық сынақтармен, реттеуші процестермен, биологиялық препараттар мен шағын молекулалы дәрілер өндірісімен және жаһандық дистрибуциямен ұштастырады.

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.

Сипаттама

  • 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

Талаптар

  • 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

Артықшылықтар

  • 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

Ұқсас жұмыс орындары

Covera Health

SVP of Engineering

Covera Health

Lead engineering for Covera Health’s AI-enabled healthcare platforms and a 30-person technology organization. Set technical direction across architecture, reliability, delivery, and cross-functional strategy.

Ашу
Eli Technologies

Staff Engineer, Remote (New York)

Eli Technologies

Lead the design of Eli Technologies’ ledger, AI decisioning, and platform systems. Build auditable software that helps energy programs manage projects and pay contractors.

Ашу
Supermicro

Product Engineer, Rack Systems — Supermicro, San Jose

Supermicro
5 001 – 10 000 Қызметкерлер
КонсалтингЛогистикаӨндіріс

Configure and document rack systems for Supermicro’s data center, cloud, and enterprise IT solutions. Support technical sales, compatibility checks, delivery issue resolution, and customer projects across teams.

Ашу
NinjaOne

Mid-Market Account Executive, Austin Hybrid

NinjaOne

Sell NinjaOne’s unified IT operations platform to mid-market and enterprise prospects. Own warm-lead sales cycles, product demonstrations, negotiations, forecasting, and quota performance.

Ашу
NinjaOne

Mid-Market Account Executive, SaaS Sales

NinjaOne

Close warm leads and guide mid-market prospects through sales cycles for NinjaOne’s unified IT operations platform. The role covers Austin hybrid or New Jersey remote territories.

Ашу
NinjaOne

Mid-Market Account Executive, Central and Plains

NinjaOne

Manage mid-market SaaS sales for NinjaOne, from qualifying warm leads and delivering product demonstrations to forecasting opportunities and closing strategic accounts. Own a defined territory and work toward monthly and annual sales targets.

Ашу
Eli Technologies

Senior Software Engineer

Eli Technologies

Build Eli Technologies’ platform for automating energy program eligibility, documentation, payments, and reconciliation. Take ownership of AI-assisted decisions, financial systems, and production infrastructure.

Ашу
Eli Technologies

Staff Software Engineer, Hybrid (California)

Eli Technologies

Lead TypeScript platform engineering for Eli Technologies’ energy programs, spanning AI-assisted decisions, financial ledgers, payments, and production reliability.

Ашу
Careers at Crown

Dock Door Account Representative

Careers at Crown

Crown Equipment is hiring a dock door equipment sales representative to manage customer accounts and territory sales. The role includes product demonstrations, developing service opportunities, and growing business across an assigned territory.

Ашу
NinjaOne

Mid-Market Account Executive – NinjaOne

NinjaOne

Own the sales cycle for warm B2B SaaS leads across NinjaOne’s strategic mid-market accounts. Run discovery, demos, negotiations, and forecasting while growing revenue in Austin or Western Canada.

Ашу