Principal Systems Analyst - Model N

Role Summary

Role focuses on anticipating and analyzing user requirements to design new IT application solutions and/or enhancements to existing solutions in order to meet new business needs and solve business problems. It applies a broad range of expertise in IT design, development, standards, procedures and compliance requirements to deliver complex solutions aligned with business and IT strategies. The role also supports existing systems by providing knowledge and training to users and coordinating resolutions to system-related issues. It plans, organizes and directs the tactical and strategic operational activities of the IT team.

Responsibilities

• Analyzes & Fulfills Business Needs:
  • Analyzes new needs in determining the solution approach and scope; participates in buy or build analysis
  • Analyzes user requirements and develops functional specifications for complex systems
  • Designs, develops and executes test scenarios and scripts to ensure the developed system(s) meet the technical and functional specifications; assesses and develops validation requirements; conducts functional testing, performance testing and integration testing; plans and coordinates user acceptance testing; documents the results of all tests
  • Leads in the development and/or maintenance of technical designs and specifications from functional specifications for systems of simple to moderate complexity; develops URS, FRS, TDS, DFD, test cases, traceability matrix and other design documents; reconciles design models with business requirements; designs application prototypes when necessary
  • Reviews and provides input for developing effective user and system documentation
  • Identifies the skills and resources needed to implement a new system or to enhance an existing system, and prepares cost estimates for development and timeline required to implement
• Builds Relationships & Influences Key Stakeholders:
  • Builds trusting, collaborative relationships with internal and external stakeholders, which help accomplish key business objectives
  • Develops and communicates strong, fact based rationales to build support for ones perspectives and initiatives
• Develops & Maintains Systems, Applications & Infrastructure:
  • Directs and leads prioritization of input to CAB process; identifies and plans responses for change requests (RFCs) by assessing the requests, technical options, and feasibility and impacts of options
  • Consults with and advises members of the application development staff on the system design aspects, business rules and processes and the use of various technologies, tools, standards, methods and best practices
  • Creates and advises in the creation of detailed functional specifications defining the system capabilities to be implemented along with accompanying data models, process models, and impact on IT and LoB processes
  • Ensures system design adheres to compliance requirements, SOX requirements, and other technology standards both local and corporate
  • Provides a primary point of contact for supporting the applications and coordinating all change functions in support of one or more specific business processes or areas
• Leverages Technology Principles, Knowledge & Practices:
  • Utilizes advanced IT knowledge to uncover unmet needs of stakeholders within Novo Nordisk, and communicates them to the technical staff and ensures all needs are met
  • Facilitates the technical communication and coordination among the project team, other technical staff and external vendors
  • Possesses and provides subject matter expertise for the various system solutions and the supported business processes
  • Ensures all stakeholder needs are met by communicating them to the technical staff
• Manages IT Vendors:
  • Ensures that vendors are compliant with contract expectations, and negotiates contracts to meet current and future work requirements
  • Evaluates vendor performance and effectiveness (i.e., against KPIs and SLAs) and makes recommendations for selecting vendors for future opportunities
• Team Leadership:
  • Helps others to build capabilities by proactively providing constructive feedback & coaching
  • Strategically seeks out, builds and maintains trusting and collaborative relationships with peers and senior staff members in IT and LoB to meet business needs and demands
  • Works with others to build mutual understanding and a shared vision of success
• Understands & Applies Risk Management Practices:
  • Leverages advanced knowledge of risk management processes and guidelines to ensure compliance and proactively identify risks throughout the system lifecycle
  • Uses in-depth knowledge of current and emerging risk management practices, and provides insight into the long-term implications of changes to ensure the sustainability of processes, projects and systems

Qualifications

• Required: BS Degree in Computer Science, Information Systems, Business Administration or other related field. Solid relevant experience may be substituted when appropriate.
• Preferred: Advanced degree.
• Required: Minimum of 12 years of relevant experience in Computer Science, IT, programming/systems analysis or other related experience with expertise in strategic platforms such as SAP, ModelN, Veeva, etc.
• Required: Ability to establish and maintain effective working relationships
• Required: Ability to independently determine and develop approaches to solutions; a demonstrated problem solver
• Required: Ability to lead, coordinate activities and provide technical support to project teams
• Required: Ability to provide technical solutions to a wide range of complex problems
• Required: Demonstrated superior written and oral communication skill at all levels
• Required: Demonstrates leadership capabilities; has the ability to act as a project lead in the development and implementation of process
• Required: Excellent technical writing, document organization, technical document review and analytical thinking skills are required
• Required: Experience in developing and measuring system performance KPIs and conducting post implementation reviews
• Required: Experience managing, integrating, and loading large volumes of data
• Required: Knowledge of CFR Title 21 Part 11 requirements, FDA regulated environments, industry practices on computer validation, and Sarbanes-Oxley regulatory requirements of computerized systems
• Required: Knowledge of operating systems (Windows, Unix and Linux), relational database architectures, query languages and interfaces, standard programming environments, data integration tools, application integration solutions, and web-based information solutions
• Required: Proficient with test case writing and execution
• Required: Project team lead experience
• Required: Superior attention to detail

Additional Requirements

• 0-10% overnight travel required