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Associate Director, Regulatory (RIM) Business Systems and Operations

Daiichi Sankyo, Inc. -
Basking Ridge, NJ

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Job Details

$157,920 - $236,880 a year

Qualifications

Data compliance
GxP
Regulatory compliance
Cross-functional collaboration
Research & development
Cross-functional communication

Full Job Description

Job Title:
Associate Director, Regulatory (RIM) Business Systems and Operations

Job Requisition ID:
1483

Posting Start Date:
6/8/26

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

Job Summary

The Associate Director, Business Systems & Operations Management is responsible for managing the operational, administrative, and tactical support of assigned business systems; as well as contributing to projects and initiatives that optimize the use of information technology to achieve departmental, divisional, and enterprise business objectives.

The Associate Director, Business Systems & Operations Management will function at various times as a manager of one or more business systems, as a leader of sub-teams or workstreams within larger projects or programs, as a contributor within various systems-related working groups, and as a senior business analyst, as required. This role regularly collaborates with business leadership, business process owners, business analysts, R&D Excellence team members, and information technology leads and specialists. This role often involves the oversight of internal or contracted staff. This individual works under the direction of the Global Business System Owner in supporting one or more Line Functions as a part of 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, but not limited, to user access, user experience, procedural documents, user training, and issue resolution

Identify, evaluate, and prioritize proposed changes to assigned systems 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

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 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, and project charter to clearly articulate the business challenge, benefits, and approach to affect positive information management change

Lead and participate in the establishment 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

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

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

Responsibilities Continued

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 collaborative 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, 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

Education Qualifications

Bachelor's Degree in Computer Science, Life Science, Engineering, Business Administration or a related discipline or equivalent work experience is required.

Master's Degree in Life Sciences preferred

Experience Qualifications

Minimum of 7 years of experience within life sciences supporting the delivery of GXP validated global business systems serving cross-functional stakeholders is required

Demonstrated experience within or supporting Research & Development processes, roles and systems is 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

Experience with Veeva RIM is preferred.

Demonstrated experience managing IT systems either on the IT or Business side is required

Excellent oral and written skills are required

Demonstrated experience involving data governance and/or data stewardship is preferred

Knowledge of key industry regulations relating to the compliance of IT Data and Systems is required

Proven ability to work in a global and highly matrixed environment is preferred

Experience supporting an audit/inspection of an IT system is 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

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