Migration Capability Lead, Regulatory Affairs Platform Operations
Migration Capability Lead, Regulatory Affairs Platform Operations
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$ 132300 - 245700
1 Vacancy
Job Description
Band
Level 5Job Description Summary
As a member of the Regulatory Affairs (RA) Platform Operations team the Migration Capability Lead will play a pivotal role in enhancing the organizations operational efficiency and technological advancement. This position is crucial for planning and delivering the migration aspects of production releases of Technology Products across RA Data & Technology Platforms.The Migration Capability Lead is responsible for ensuring that all Data Content systems migrations are executed seamlessly so that releases are deployed successfully thereby minimizing disruptions to business operations. This role directly impacts the organizations ability to meet business needs and technical standards ensuring the continuity and reliability of the Regulatory Affairs Technology infrastructure.
Job Description
Key Responsibilities:
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
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 SOPsWIs 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
Essential Requirements:
- Bachelors degree masters; 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 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 business writing communication and effective presentation skills
- Excellent problem-solving skills and in seeking clarity in ambiguous situations
- Leadership in risk assessment strategic thinking prioritization and global awareness
Desirable Experience
- 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
he salary for this position is expected to range between $132300 and $245700 per year.
The final salary offered is determined based on factors like but not limited to relevant skills and experience and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and depending on the level of the role eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health life and disability benefits a 401(k) with company contribution and match and a variety of other addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an e-mail to call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Range
Skills Desired
Data Analysis Documentation Management Lifesciences Proactivity Process Improvement Regulatory Compliance Waterfall ModelEmployment Type
Full-Time
