Summary

This role purpose is to act as a consultant and advisor providing guidance to improve complex global business processes, products, and services. We are looking for an experienced individual in Global Drug Development Regulatory Affairs to lead the business analysis activities for the solutions that re-define how Novartis operates.

You will be working on strategic initiatives with the mandate to deliver solutions, which will bring transformative change to the business domain and will allow Novartis to realize a competitive advantage.

#LI-Hybrid

About the Role

Role Responsibilities:

• Engage with global business associates and leverage the appropriate teams and business functions to determine requirements and deliver data-driven recommendations to improve efficiency and add value.
• Analyses the business domain and author business requirements. Coordinate and facilitate ongoing reviews of business processes.
• Ensure consistency and traceability between user requirements, functional specifications, and testing & validation. Support the validation and testing as appropriate.
• Work closely with Project Manager and workstream leads. Work together with a product squad in delivering the Product's roadmap. Actively participate in sprint planning discussions and ensure sprint functional deliverables (prioritized backlog, user stories completed and demonstrated etc.) are on track.
• Liaise with vendor, Novartis internal IT teams and business to ensure documentation is at the appropriate level of details and that the requirements are accurately interpreted and implemented.
• Act as interface between business and Implementation partners. Review the sprint demos and ensure that gaps are documented.

• Bachelor's degree in engineering or pharmaceutical discipline. An advanced degree (MBA, MS etc.) and related accreditations (IIBA, Veeva, Agile certifications etc.) is a plus.
• 7+ years of IT Business Analysis experience with excellent communication skills.
• Must have proven strong knowledge of SDLC, Validation & Compliance
• Proficiency with tools such as Jira, Confluence, HPQC, Business process modelling tools
• Experience in Data migration and System integration related projects.
• Experience in managing GxP Projects and related fields
• Multi-national global experience in interacting with senior management, collaborating across boundaries and relationship management, and influencing without authority.
• Experience in Regulatory Affairs business processes is a plus (e.g. Registration Management, Submission Management, Submission Content management, Submission Publishing & Clinical Publishing, Product Labelling)

• Implementation experience of Veeva Submission and Registration module is a plus.