Administrative Skills, Artificial Intelligence (AI), Biotech and Pharmaceutical, Business Ethics, Business Strategy, Cross-Functional, Data Science, Ecosystems, Employee Relations, Engineering, Establish Priorities, Information Technology & Information Systems, Lean Manufacturing, Lean Six Sigma, Maintain Compliance, Manufacturing, Marketing, Medical Products, Performance Metrics, Process Development, Process Engineering, Process Improvement, Regulations, Supply Chain, Systems Analysis, Taxonomies, Time Management, Value Chain Model, Vendor/Supplier Selection
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong to Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.
Astellas' Global Capability Centers - Overview
Astellas' Global Capability Centers (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are in India, Poland and Mexico.
The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.
Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company's strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.
This position is based in Bengaluru and will require some on-site work.
Purpose and Scope:
The Partner RA Data Governance should know how the Regulatory systems interact, and how they interface with other aspects of the Astellas information ecosystem. Responsibilities involve identifying and ensuring adherence to relevant data standards; and establishing relationships with key personnel within the global RAPV organization to identify process improvements. The position also requires collaboration to ensure consistency in interactions with multiple regional health authorities and other Astellas functions such as Marketing Operations, Data Science, Supply Chain, Manufacturing and other relevant areas across Astellas. The Partner RA Data Governance also leads or otherwise participates in significant and complex project teams/task forces.
Responsibilities and Accountabilities:
- Incorporates industry specifications/initiatives into our processes and deliverables
- Contributes to and sometimes leads cross-functional and/or industry initiatives including IT system
implementations and process re-engineering projects
- Contributes to RAPV strategy by implementing actionable plans for near- and long- process improvements involving RAPV systems as well as interactions with other functions such as supply chain, or Pharm Tech.
- Monitors the availability of and identifies ways to leverage opportunities provided by evolving Artificial Intelligence and other advanced digital capabilities
- Ensures compliance in processes and systems with both internal and external procedure and guidelines/legislation
- Tracks alignment of operating models across all concerned RAPV functional departments during vendor/system selection activities, while preparing for new/major system implementations, and evaluating ongoing process improvement opportunities in steady-state
- Implements methods to evaluate processes and standards against Key Performance Indicators, leveraging methodologies such as Lean Six Sigma where applicable
- Leads or participates in cross-functional initiatives involving regulatory information, with particular emphasis on integrations with systems outside of RAPV, shared information taxonomies and data dictionaries
- Leads or participates in industry working groups to represent Astellas, often in collaboration with other RA members including Regulatory Intelligence colleagues, spanning information needs for all RA functional departments
- Liaises with Information Systems and other Planning and Administrative functions on a variety of topics including platform strategies and IT roadmap prioritization
A
Astellas Pharma Inc
Astellas Pharma US, Inc., is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Located in Northbrook, Illinois, the company serves as the headquarters for the Americas and employs nearly 3,000 people. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.
Our commitment to changing tomorrow is measured not only by our focus on bringing innovative and effective new medicines to patients and physicians, but also by the importance we place on the impact we can make within the communities where we work and live. Astellas supports many causes and has created two initiatives to demonstrate our commitment: Changing Tomorrow Day, an annual, worldwide volunteer event, and Science WoRx, a nationwide mentoring program and online resource network for science teachers and their students.
2,500 to 4,999 employees
Biotechnology/Pharmaceuticals
https://www.astellas.com/us/