Astellas is a global life sciences company committed to turning cutting-edge science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace current ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact
Purpose and Scope:
The Clinical Data Information Specialist position is an exciting prospect to significantly contribute towards the compliance requirements of Astellas, by developing relevant and applicable data management solutions on the Regulatory data modelling platform.
This role is critical for managing regulatory information utilizing IDMP requirements as a baseline. It involves building a system landscape that unlocks the potential of data, wherein a centralized repository for accurate and up-to-date regulatory information.
In close collaboration with DigitalX Pod or Value Team Captains and business leads, this role will facilitate IDMP, CMC, and other regulatory requirements through the creation, governance, and maintenance of accurate, unique, and standardized data records and models, reducing time for product approvals. The role will be responsible for defining and implementing data modeling standards, business rules, data structures, and relationships that support regulatory data domains, while fully leveraging platform capabilities and functionality to enforce data standardization, quality, and uniqueness. This will be aligned with IDMP requirements to enable interoperability and seamless data e
📌 Clinical Data Informatics Specialist (India)
🏢 Astellas Pharma
📍 India
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