Sr. Business Analyst DDIT DEV RA

Your responsibilities include but are not limited to

• Develop project rationale and perform scoping assessments to determine feasibility of projects
• Research and assessment of leading products and offerings from various solution providers in the areas of Knowledge Management, Structured Content Management and translation
• Analyze the regulations coming up in the Regulatory Affairs area in collaboration with the business SMES to determine the impact on existing business processes and IT system configurations
• Work closely with business functions to identify AI opportunities, build business cases, and ensure AI investments deliver measurable business value.
• Develop a comprehensive requirement specification that will determine the estimate of cost, time and resources to implement new solutions for ensuring regulatory compliance.
• Support RFP process for vendor selection
• Liaise between product vendor and business stakeholders to finalize the functional scope
• Support in the development of project estimates and complete financial model (costs, savings, revenue opportunities, investment horizon, etc.)

What you’ll bring to the role:

• Ensure the overall user experience is taken into account when designing and deploying new solutions and services
• Ensure consistency and traceability between user requirements, functional specifications and testing & validation. Support validation and testing (OQ, PQ, UAT...)
• Ensure implemented solutions are according to specifications and fit for purpose.
• Support super user training, Keep abreast with internal IT systems and documentation requirements, standards (including quality management and IT security)
• Take accountability to ensure adherence with Security and Compliance policies and procedures within Service Delivery scope
• Experience in Managing GxP Projects and Related Fields is a plus and ability to manage medium size teams as part of project execution. Knowledge on business process modelling and canonical

Desirable Requirements:

• Bachelor’s degree in engineering, Computer Science/Information Technology,
• Min 10 years’ experience in SDLC, system validation and Business Analyst role
• 5+ years in Drug Development domain and experience working in AI based solutions implementation for document generation, management
• Implementation experience of products in the Regulatory affairs area like, Veeva Vault, Documentum, Docuvera, Yseop etc.
• Knowledge of component based structured authoring solutions
• Life sciences Regulatory domain knowledge
• Proficiency with tools such as Jira, Confluence, Business process modelling tools

Commitment to Diversity & Inclusion:

Novartis embraces diversity, equal opportunity, and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

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

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