Band
Level 5
Job Description Summary
As a member of the RA Data Strategy and Management Platform, the Business Architecture & Data Integrations Capability Lead owns and oversees all aspects the Capability and contributes to the overall Platform strategy delivering business benefits, harmonization and continuous improvements.The Business Architecture & Data Integrations Capability lead is accountable for the overall cataloging of business data, defining data model requirements and Data Integration requirements. This role requires a deep understanding of regulatory data and how it flows through systems across the regulatory landscape, e.g. Data Lakes, Enterprise Data Warehouses, 3rd-party data integrations, regulatory technology solutions, etc. and how data flows in the registrations ecosystem across the Novartis Enterprise.
Job Description
Major accountabilities:
- Lead a team to ensure alignment with organizational goals and business priorities related to Business Architecture and Data Integrations
- Support the strategic vision for the Data Strategy and Management Platform, from a Capability level
- Define, prioritize, and deploy an integrated Capability roadmap working in close collaboration with relevant stakeholders and DDIT partners, ensuring alignment with the Data Strategy and Management Platform, Development and Enterprise data and technology strategy roadmaps
- Represent the Capability in digital governance boards and leadership meetings across the organization
- Represent the Capability in digital networks, externally (e.g. across Industries) as needed
- Oversee integrations with Products underlying the Capability
- Build and maintain collaborative and productive partnerships within the Capability and the Platform, and with relevant stakeholders to achieve business priorities.
- Oversees the cataloging and technical controls of the RA Data model in line with Novartis strategy and Industry Standards, business data architecture, Logical data model, Integration requirements, data model requirements and approves and secures data governance policies and processes
Minimum Requirements:
- Bachelor’s degree, master’s; Advanced degree in life science, pharmaceutical, technology or data science preferred.
- 8+ years of relevant industry experience
- Strong understanding and direct relevant experience with the Business Architecture and Data Integrations landscape of pharmaceutical regulatory affairs and Regulatory Information Management
- Practical experience in technology process requirements and business administration management
- Deep knowledge of regulatory standards and structured data submissions
- Strong network and exposure to the external environment and ability to represent company and influence in Trade organizations (e.g., EFPIA, PhRMA), International Organizations (ISO), and collaboration with regulators (e.g. ICH, EMA SPOR), or consortiums
- Strong strategic problem-solving skills and ability to navigate un-charted territory without clear precedent
- Experience presenting/speaking at a senior management level with a proven track record of effectively communicating complex initiatives
- Demonstrated leadership in driving risk assessment and mitigation, clear strategic thinking, prioritization, maintaining awareness of business impact
- Excellent verbal and written communications
- Strong negotiation skills
- Broad experience in quality assurance/compliance, computer system validation within the pharmaceutical/biotech arena, the management and conduct of audits, stakeholder focus, and strong knowledge of regulatory requirements
Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Skills Desired
Data Analysis, Documentation Management, Lifesciences, Proactivity, Process Improvement, Regulatory Compliance, Waterfall Model
