Major accountabilities:

Team Leadership:

• Lead a team to ensure alignment with organizational goals and business priorities related to Migration activities, and support the strategic vision for Platform Operations from a Capability level; foster a culture of excellence and continuous improvement 
• Act as a Change Lead and implement change management strategies to ensure smooth adoption of technology initiatives, at the Capability level

Roadmap Development:

• Responsible for the oversight, the planning and the continuous execution of migration activities across Technology Projects/Products, and their alignment as part of an integrated roadmap, from a Capability level
• Coordinate with relevant affected Products/Capabilities/Platforms Teams to manage dependencies across multiple releases and ensure alignment of data, system configurations and user experience. Ensure that any interdependencies are identified, tracked, and resolved in a timely manner to prevent delays or conflicts, from a Capability level

Stakeholder Engagement:

• 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
• Communicate effectively to ensure understanding and support for new technology initiatives
• Support continuous expansion of knowledge and foster the adoption of a digital mindset within Regulatory Affairs

Collaboration and Partnerships:

• Build and maintain collaborative and productive partnerships within the Capability and the Platform, and with relevant stakeholders to achieve business priorities.
• Oversee vendors at the capability level, across product(s), in collaboration with IT and the External Partnerships Teams

Quality and Compliance:

• Ensure on-time, compliant, secure, and quality delivery of portfolio for the assigned Capability/Product(s), aligned with the NVS Quality Manual
• Ensure adherence to Security and Compliance policies and procedures within the scope of the Capability and prepare for audit readiness and inspection requirements (incl. Related mitigations or actions triggered by audits & inspections).

Migration activities:

• Ensure preparedness and successful migration activities in the context of new releases, across Products, to ensure compliance with regulatory and industry standards within the life sciences sector
• Ensure Migration Capability is fit for purpose (incl. related processes such as SOPs, WIs, Best Practices, etc.) and achieves the desired business value and impact
• Identify, assess, and manage risks associated with migration activities. Develop contingency plans to address potential issues and ensure minimal disruption to business operations
• Lead the resolution of complex migration issues, providing expert advice and solutions
• Establish key performance indicators (KPIs) to measure the effectiveness of the migration process. Regularly track and report on these metrics to identify areas for improvement and demonstrate the value of the capability team
• Establish and maintain migration frameworks/standards, and manage/execute migration projects, ensuring a seamless transition and integration of new Systems, Data and Products with minimal disruption to business, including but not limited to: Migration Plan, Data Mapping, Data Extraction Scripts, Data Cleansing Reports, Transformation Logic, Migration Scripts/Programs, etc.

Project and Program Support:

• Provide support/resources for key projects and programs impacting the Capability and/or underlying Service(s)/Product(s), ensuring timely delivery of high-quality milestones in alignment with business requirements

Demand Management:

• Effectively manage demand(s) for technology services and operational support related to validation activities, arising from various functions withing Regulatory Affairs
• Monitor service delivery performance and backlog

Industry Trends:

. Stay updated with industry trends and emerging practices to drive agility, innovation, speed, efficiency, effectiveness, and continuous improvement within the Capability

Key performance indicators:

• Achieve key Regulatory Affairs business objectives and stakeholder milestones by leading the Capability, ensuring timely and on budget delivery of the Capability roadmap
• Migrate data & content as part of Releases supported by the Capability in a timely and successful manner (e.g. through the measure of percentage of successful migrations, level of data integrity post-migration, percentage of migrations completed on schedule, average time taken for migrations, number of migration-related issues, etc.)
• Improve user experience for solutions and services for product(s) underlying the capability
• Enable RA operational execution through dedicated management of the Capability and underlying Products and Services, maximizing the value provided by our systems:
• Improvement of the landscape performance and user satisfaction
• Adoption and harmonization of high performing technology solutions leading to simplification of the landscape and reduction in number of systems, delivered on time and in budget
• No critical findings in audits and inspections related to the migration process for RA Products

Minimum Requirements:

Bachelor’s degree, master’s; Advanced degree in life science, pharmaceutical, technology, or data science preferred
Work Experience and Skills:

• 8+ years of relevant industry experience
• Strong understanding and direct relevant experience with the Migration landscape of pharmaceutical regulatory affairs
• Advance knowledge of drug development process as well as international drug registration and approval, of Regulatory Business processes and information management
• Hands-on experience in technology process requirements
• Extensive experience leading meetings, driving change and cross-functional teams
• Excellent problem-solving skills and in seeking clarity in ambiguous situations
• Leadership in risk assessment, strategic thinking, prioritization, and global awareness
• Excellent business writing, communication and effective presentation skills
• Technically savvy
• Broad experience in quality assurance/compliance, computer system validation within the pharmaceutical/biotech arena, and strong knowledge of relevant regulatory requirements
• Strong experience in data/content migration activities in the context of major projects/releases

Languages :

• Fluency in English as Business language