Director, Regulatory Information Management - Business System Lead in Basking Ridge at Daiichi Sankyo

Date Posted: 12/7/2022

Job Snapshot

  • Employee Type:
  • Location:
    Basking Ridge
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description


The Business Systems Lead is responsible for providing or managing the operational, administrative, and tactical support of 1 or more business systems typically in a single function, along with inputting into the broader systems strategy and landscape. This role may serve as lead or contributor on projects and initiatives that optimize the use of information technology to achieve R&D and enterprise business objectives. The Business Systems Lead will function as a manager of one or more business systems, as a leader of sub-teams or workstreams within larger projects or programs, enhancements or changes, as a lead/contributor within various systems-related working groups, and as an experienced business analyst, as required.

This role regularly collaborates with leadership, business process owners, R&D Excellence team members, and information technology leads and specialists. The Business Systems Lead works under the direction of the Global Business Systems Owner in supporting one or more Line Functions as a part of the R&D Excellence Systems Management group. This role will have direct line management of RDEx business system analysts and project managers along with indirect management of business process engineers, trainers, organizational change managers and data analysts supporting systems projects within RDEx.


  • Systems Administration & Operational Support
    Lead the day-to-day management of the administrative and operational support of assigned systems
    Monitor, assess, and improve the administrative and operational support processes – including, but not limited, to user access, user experience, user adoption, procedural documents, user training, and issue resolution
    Identify, evaluate, govern, and prioritize proposed changes to assigned systems anchored to a roadmap, to address the evolving requirements of the user community and to support imperatives identified by Line Function leadership
    Ensure data within assigned systems is maintained to the highest levels of quality and defined standards, and propose improvements to address gaps or sustainability concerns
    Manage user access and monitor/manage ticket resolution/escalation
    Perform periodic voice-of-customer exercises for assigned systems to identify any necessary maintenance, expansion, or user experience improvements
    Define and monitor key metrics of risk and performance for assigned systems
    In collaboration with IT partners, determine the necessary Business/IT resource, budget and Steering Committee required on future IT projects
    Determine and track KPIs related to system utilization, stability, and data quality against defined targets for assigned systems
    Initiate periodic critical reviews of the overall effectiveness of assigned system, which includes taking any necessary corrective or preventive action to ensure continued success
    In collaboration with IT, maintain effective relationships with solution vendors to ensure R&D short and long-term objectives are met within each platform, with an eye towards continuous improvement
  • Project Execution
    Lead all business-led project deliverables including – but, not limited to – process engineering or reengineering, user requirements definition, test scenario & test case development, user training, acceptance testing, and business support & administration
    Ensure that all large and small projects have a formal problem/opportunity statement, business case, return on investment and project charter to clearly articulate the business challenge, benefits, and approach to affect positive information management change
    Oversee the establishment and management of integrated project plans, timelines, resourcing requirements, and risk/issue management evaluations for all projects to ensure on-time, high-quality delivery
    Ensure that the implementation or improvement of all GxP R&D Systems are properly documented to support business utilization and inspection readiness. Support system related inspections as required.
    Identify, investigate, escalate (if necessary), and develop mitigation approaches to identified risks & issues, and/or to overcome any challenges to successful delivery
    Manage and oversee the allocation, performance, and collaboration of internal & external project resources to ensure optimal delivery of R&D systems
    Manage approved budget expenditures and funded resources to effectively deliver system needs on-time, to budget, and with high quality
    Provide regular project status reports identifying progress, risks, mitigation strategies, and timelines for the benefit of stakeholders, leadership, and governance committees
    Lead and/or contribute to working groups or teams formed to address areas of improvement within the R&D scope of operations
    Ensure quality and oversight of delivery partners (DX,DSI IT etc) is in-line with expectations, with clear communication and escalation where needed
    Lead or contribute to ad hoc projects or initiatives, as assigned
  • Business Analysis
    Function as an experienced Business Systems Analyst within large projects or other appropriate situations, as assigned by the Global Business Systems Owner
    Directly develop formal problem/opportunity statements, business cases, and project charters to clearly articulate the business challenge, benefits, and approach to affect positive information management change, as required
    Provide business-focused project deliverables including – but, not limited to – process engineering or reengineering, user requirements definition, test scenario & test case development, user training, acceptance testing, and business support & administration
  • Relationships & Collaboration
    Collaborate with other Global R&D Excellence team members to work in a harmonized fashion across areas of specialization to support project and R&D objectives
    Build and maintain close relationships with subject matter experts, information technology colleagues, business leads, vendors and external resources in executing projects or other initiatives
    Contribute to System Roadmaps across assigned systems including current and planned release schedules and strategic investment direction

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university)

  • Bachelor's Degree Computer Science, Life Science, Engineering, Business Administration or a related discipline or equivalent work experience required
  • Master's Degree Life Sciences or Information Systems preferred

Experience Qualifications

  • Minimum of 10 years of experience within life sciences supporting the delivery of GXP validated global business systems serving cross-functional stakeholders is required required
  • Demonstrated experience within or supporting Research & Development processes, roles and systems is required required
  • Demonstrated experience serving as the liaison between Business & IT, translating business needs into technical solutions and technical considerations into business language is required required
  • Demonstrated experience managing R&D systems either on the IT or Business side is required required
  • Excellent oral and written skills are required required
  • Demonstrated experience involving data governance and/or data stewardship is preferred preferred
  • Knowledge of key industry regulations relating to the compliance of IT Data and Systems is required required
  • Proven ability to work in a global and highly matrixed environment is preferred preferred
  • Experience supporting an audit/inspection of an IT system is preferred preferred
  • Line Management experience of Business System Analysts, Project Managers and Business Process Engineers to deliver IT Projects is required required