Join a Legacy of Innovation 110 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, and analytics for RA. This will include working within and optimizing the defined, R&D data governance approach to facilitate consistency and quality of data across key Daiichi Sankyo regulatory systems. This includes defining regulatory data standards, data quality rules and data governance processes across GRA, and driving continuous improvement efforts for data-related topics. This role will also work on defining business requirements for reporting and analytics. The individual in this role will also be responsible for driving analytics and reporting capabilities, incl. creating reports and dashboards of key regulatory data/metrics from across systems, leveraging technical integrations and automation where possible, and using analytics tools to track process metrics/KPIs and flag areas to address process performance/adherence. As a result, this role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as well as cross-functional stakeholders (e.g., RA CMC, R&D Excellence, Clinical Operations, IT).
Responsibilities
Operate within and in support of the established RD data governance framework
Coordinate GRA’s data strategy with broader corporate IT projects and objectives
Gather business requirements for reporting and analytics
Develop, maintain and make available relevant regulatory reports and dashboards
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)
Experience Qualifications
Travel
Ability to travel up to 10% business travel
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.
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