Global Regulatory Data Manager

2 weeks ago

Bernards Twp, United States Daiichi Sankyo Full time

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

  • Partner with RD Excellence to support ongoing process improvement related to data governance to ensure data integrity, quality, consistency, and compliance with regulatory requirements.
  • Define data governance principles, policies, and standards specific to GRA, in line with corporate data policy.
  • Collaborate with cross-functional stakeholders (incl. RD / Corporate teams) to define data ownership, and data quality requirements.
  • Continuously assess and improve the data governance approach/framework with a continuous improvement mindset.

Coordinate GRA's data strategy with broader corporate IT projects and objectives

  • Collaborate with Corporate IT to align GRAs data strategy with the overall corporate IT strategy and objectives, particularly as corporate IT policies evolve
  • Drive initiatives to maximize integration and interoperability of GRA data with the broader enterprise infrastructure
  • Facilitate communication and collaboration between GRA and IT teams to address data-related challenges and leverage the latest technologies and tools available

Gather business requirements for reporting and analytics

  • Engage with key stakeholders, including Regulatory Affairs teams and cross-functional project team members, to gather business requirements for reporting and analytics.
  • Conduct analysis to identify business needs across GRA sub-functions
  • Translate business requirements into technical specifications and data models to guide the development of reporting and analytics solutions
  • Utilize fit-for-purpose analytics tools and techniques, to derive actionable insights from regulatory and operational data
  • Collaborate with stakeholders to prioritize and execute analytics and data-related projects aligned with GRAs strategic objectives (incl. coordinating external vendors or partners)

Develop, maintain and make available relevant regulatory reports and dashboards

  • Stay up to date on KPIs for Regulatory organizations
  • Drive ongoing optimization of GRA metrics and KPI definition
  • Develop reporting and dashboarding solutions to meet GRA needs and enable visibility across regions and sub-functions
  • Partner with the Process Excellence Lead and others to identify process improvements based on insights gathered; ensure new process definition keeps in mind KPIs and reporting best practices
  • Enable appropriate level of "self-service" for metrics accessibility (e.g., report for upcoming planned submissions)
  • Communicate findings and recommendations to key stakeholders through effective, visual materials

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)

  • Bachelors Degree Data Science, Computer Science, Engineering, Statistics, or related field required.

Experience Qualifications

  • 4 or More Years Experience developing presentations (e.g., PPT) and dashboards / reports, incl. experience with relevant tools (e.g., PowerBI) required.
  • 3 or more years of Experience supporting data-related initiatives in the healthcare sector (preferably pharma) incl. owning data governance activities (e.g. developing and implementing data standards)
  • 3 or more years Experience working with international teams; strong understanding of cross-cultural environments and different business practices across key markets (JP, US, EU preferred)
  • 2 or more years Familiarity with pharma and regulatory information management systems (RIMS); Veeva Vault experience preferred.

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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