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Responsibilities: Over the next few years Eli Lilly and Company’s China Regulatory Affairs function will implement electronic submission. This journey begins with understanding China regulation requirements, develop implementation plan to adapt and modify global eCTD submission process and system to meet China regulatory needs. The application analyst role will be leading technical implementation through translating business requirements into solution configuration, data integration and effective oversight of vendors. This dynamic position combines the roles of technical integrator, technologist and architect providing for personal development opportunities to become well-skilled in multiple technical disciplines. Your key responsibilities in this position will include but are not limited to: Key Objectives/Deliverables:
Delivery of technical integration of COTS or SaaS into the Lilly IT environment through installation, programming and software/data integration.
Leading a technical team in developing a technical design (configuration/development and data integration) from business requirements
Manage expectations and development activities with software vendors for project deliverables.
Obtain and leverage deep knowledge of business processes and technologies, to ensure solutions meet the needs and to influence future application and business direction
Networking and aligning technical design with architecture and internal service teams.
Impact analysis of current and future regulatory requirements on existing systems
Actively monitoring and sharing industry, supplier and regulator trends to anticipate needs and opportunities and share with peers
Communicate and adhere to the global strategy, IT processes and best practices for technology integration and solution analysis, to develop solutions that are scalable and sustainable.
Bachelor’s Degree in Computer Science or related field
Deep technical knowledge with more than 5 years of experience with software development life cycle, spanning the entire lifecycle from project initiation to development, deployment, support, and retirement
More then three years of hands on programming such as Java, .Net, scripting languages such as Perl, Python etc.
Proficient in Unix like OS and shell scripting.
Prior experience with COTS (configurable off-the-shelf) or SaaS implementations
Excellent self-management skills and ability to work independently, seeking guidance when necessary
Demonstrated initiative to build relationships, learn and identify opportunities to improve systems and processes
Prior experience working with pharmaceutical regulatory affairs
Prior experience working with pharmaceutical research and development
Experience with Software Quality Assurance methods and techniques
Experience leading teams or in formal leadership roles
Ability to influence peers
Experience working in diverse and multicultural teams
Excellent oral and written communication skills
Detail requirement and what we offer
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