Astellas Pharma
Website:
astellas.com
Job details:
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
Required Qualifications
- Bachelor’s degree (science or technology is preferred)
- At least seven years’ experience in a regulatory operations role or similar position associated with regulated processes and content in the pharma industry
- Demonstrated accomplishments and/or education will be evaluated and substituted for extent of experience, as needed
- Proven ability to coordinate priorities and tasks across project teams, committees, etc. to attain group objectives
- Proven ability to anticipate and proactively resolve project or procedural issues
- Demonstrated experience championing new processes and leading change management activities
- If managing staff, the incumbent should have experience managing people and/or teams or otherwise demonstrate the ability to do so
- Strong ability to communicate effectively in writing and verbally in English
- Ability to multi-task across multiple projects and deliverables
- High integrity to maintain confidential and proprietary information
- Ability to keep calm under pressure
Preferred Qualifications
- Advanced degree (e.g., Masters, PhD, etc.)
- Experience with managing IT systems
- Proven expertise in document management, submission publishing, registration management, labeling, quality control and/or change control systems
- Experience in defining or interacting with information taxonomies, master data management or other structured data constructs
- Experience with data warehousing, data lakes and reporting/analytics platforms
- Proficiency in other language(s) – most common/useful are Dutch, Japanese, Spanish, Portuguese, French, Russian, Chinese
Working Environment
- This position is based in Global Capability Center (GCC) in India.
- To enable collaboration within the GCC 2-3 days per week on-site working is expected
- To enable collaboration with US stakeholders, this role is expected to work 2-11 pm.
- This role will be a member of a brand or pipeline specific Value Team working following agile methodology to deliver impact
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Category RAPV Intelligence, Quality & Compliance
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
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