RA Data Governance and Quality Capability Lead

Band

Level 5

 

Job Description Summary

As a member of the RA Data Strategy and Management Platform team, the Data Governance and Quality Capability Lead is responsible for independently driving and implementing data standards and strategies for emerging data-driven HA requirements, and relevant systems’ governance processes across all domains and functions, in support of the NVS global product portfolios to improve data maturity according to RA business objectives.

The Data Governance and Quality Capability Lead is accountable to drive harmonization and continuous improvement of Data Governance related activities and initiatives in close alignment with internal and external stakeholders to improve data maturity according to RA business objectives. The Capability Lead will drive the Centralized Data Quality Management culture in Regulatory Affairs and ensure Data Quality consistency, correctness and completeness across all applicable RA systems and platforms.

 

Job Description

Major accountabilities:

• Lead a team to ensure alignment with organizational goals and business priorities related to Data Governance and Quality

• Serve as Data Governance and Quality Capability Lead for RA and as the point of contact for GDD Data team
• Lead RA cross-functional teams to develop data roadmap, in alignment with cross-domain Data Governance boards
• Accountable to create and implement data management and quality strategy
• Expert contributor to influence draft guidance on data standards / specifications / implementation from Health Authorities and Trade Organizations. Prepare interpretative analyses about impact on internal data and digital processes.
• Collaborate with Development Data Management and DDIT partners to develop and implement RA Data Governance structures (boards) and policies, ensuring involvement of Business Process Owners (BPOs) and business SMEs.
• Oversee vendors at the Capability level, in collaboration with IT and the External Partnerships Teams
• Manage Data Governance and metrics reporting on data operating model throughout the DQM lifecycle
• Responsible for configuration, decision making and outcome, impacting the capability, with involvement of relevant Business Process Owner(s), business SMEs and stakeholders

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 Data Strategy and Management landscape of pharmaceutical regulatory affairs and Regulatory Information Management
• 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
• Advanced knowledge of worldwide evolving external data standards as well as drug registration and approval processes and related document format requirements and in-depth knowledge of good Regulatory compliance and intelligence practices, policies, procedures
• Strong understanding of regulatory requirements and structured data submissions standards and initiatives
• Excellent business writing, communication and effective presentation skills.
• Extensive experience leading meetings, driving change and cross-functional teams
• Strong strategic problem-solving skills and ability to innovate, analyze and navigate un-charted territory without clear precedent, ability to troubleshoot effectively, accurately and independently.

• Strong negotiation skills

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 diversity.inclusion_ch@novartis.com 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

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

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