Global Regulatory Data Manager
Company: Daiichi Sankyo, Inc.
Location: Atlanta
Posted on: May 1, 2024
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Job Description:
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 travelDaiichi 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.
Keywords: Daiichi Sankyo, Inc., Roswell , Global Regulatory Data Manager, Executive , Atlanta, Georgia
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