Snr. Specialist, IT Business Analyst - Regulatory Affairs Job ID REQ-10018834
Aug 13, 2024
Spain
Summary Role Title: IT Business Analyst - Regulatory AffairsLocation: Barcelona#LI-HybridThis 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.
About the Role Role Responsibilities:
• Engage with global business associates and leverage the appropriate teams and 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.
• Flag issues/ changes/ risks to the 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.
Role Requirements:
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.
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 Submission Archive module is a plus.
Experience in Managing GxP Projects and Related Fields is a plus
Benefits & Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally:Novartis Life Handbook
Benefits in Spain include Company Pension plan; Life and Accidental Insurance; Meals; Allowance or Canteen in the office; Flexible working hours.
Benefits in Spain include Company Pension plan; Life and Accidental Insurance; Meals; Allowance or Canteen in the office; Flexible working hours
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
This role is based in Barcelona, Spain. Novartis is unable to offer relocation support for this role:please only apply if this location is accessible for you
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
Division Operations
Business Unit CTS
Location Spain
Site Barcelona Gran Vía
Company / Legal Entity ES06 (FCRS = ES006) Novartis Farmacéutica, S.A.
#J-18808-Ljbffr