Associate Director, Regulatory (RIM) Business Systems and Operations

Job Summary The Associate Director, Business Systems & Operations Management is responsible for managing the operational, administrative, and tactical support of assigned business systems and contributing to projects and initiatives that optimize the use of information technology to achieve departmental, divisional, and enterprise business objectives. The role functions as manager of one or more business systems, leader of sub‑teams, contributor to working groups, and senior business analyst. It collaborates with business leadership, process owners, R&D excellence team members, and IT leads and often oversees internal or contracted staff to support line functions under the Global Business System Owner within the R&D Excellence Systems Management group. Responsibilities Systems Administration & Operational Support Lead and manage the administrative and operational support of assigned systems Monitor, assess, and improve the administrative and operational support processes, including user access, user experience, procedural documents, user training, and issue resolution Identify, evaluate, and prioritize proposed changes to assigned systems to address evolving user requirements and support line function leadership imperatives Ensure data within assigned systems is maintained at the highest levels of quality and defined standards, and propose improvements to address gaps or sustainability concerns Manage user access and monitor ticket resolution and escalation Perform periodic voice‑of‑customer exercises for assigned systems to identify necessary maintenance, expansion, or user experience improvements Define and monitor key metrics of risk and performance for assigned systems 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 the assigned system, taking corrective or preventive action to ensure continued success Project Execution Lead all business‑led project deliverables, including process engineering or reengineering, user requirements definition, test scenario and test case development, user training, acceptance testing, and business support and administration Ensure that all large and small projects have a formal problem/opportunity statement, business case, and project charter that articulate the business challenge, benefits, and approach to drive positive information management change Lead and participate in establishing integrated project plans, timelines, resourcing requirements, and risk/issue management evaluations for all projects to ensure on‑time, high‑quality delivery Ensure that implementation or improvement of all GxP R&D systems is properly documented to support business utilization and inspection readiness Identify, investigate, and develop mitigation approaches to identified risks and issues, and overcome challenges to successful delivery Manage and oversee allocation, performance, and collaboration of internal and external project resources to ensure optimal delivery of R&D systems Manage approved budget expenditures and funded resources to deliver system needs on‑time, within budget, and with high quality Provide regular project status reports identifying progress, risks, mitigation strategies, and timelines for stakeholders, leadership, and governance committees Lead or contribute to working groups or teams formed to address areas of improvement within the R&D scope of operations 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 Responsibilities Continued Directly develop formal problem/opportunity statements, business cases, and project charters to articulate the business challenge, benefits, and approach to positive information management change Provide business‑focused project deliverables, including process engineering or reengineering, user requirements definition, test scenario and test case development, user training, acceptance testing, and business support and administration Relationships & Collaboration Collaborate with other Global R&D Excellence team members to work collaboratively across areas of specialization to support project and R&D objectives Build and maintain close relationships with subject matter experts, IT colleagues, business leads, and external resources to execute projects or initiatives Contribute to system roadmaps across assigned systems, including current and planned release schedules and strategic investment direction Qualifications Education Qualifications Bachelor’s Degree in Computer Science, Life Science, Engineering, Business Administration, or a related discipline, or equivalent work experience Master’s Degree in Life Sciences (preferred) Experience Qualifications Minimum of 7 years of experience in life sciences supporting GxP validated global business systems serving cross‑functional stakeholders Demonstrated experience in or supporting R&D processes, roles, and systems Served as liaison between business and IT, translating business needs into technical solutions and vice versa Experience with Veeva RIM (preferred) Experience managing IT systems either on the IT or business side Excellent oral and written communication skills Experience in data governance or stewardship (preferred) Knowledge of key industry regulations relating to IT data and system compliance Proven ability to work in a global, highly matrixed environment (preferred) Experience supporting audit or inspection of an IT system (preferred) Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range USD$157,920.00 – USD$236,880.00 #J-18808-Ljbffr