Job Description Summary
Location: Barcelona #LI-HybridNovartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
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 technical 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.
Job Description
Role Responsibilities:
Create the detailed process designs necessary to operate the software/service on a day-to-day basis
Ensure designs produced adhere to architectural roadmap and support the development, execution and operations of software/service
Ensure that detailed designs adhere to solution architecture design (i.e. high-level conceptual design) and are traceable to functional as well as non-functional requirements in functional specification
Ensure the overall user experience is considered when designing new solutions and services.
Take accountability to ensure adherence with security and compliance policies and procedures within Service Delivery scope
Provide input to project proposals related to new technologies/innovations
Drive Proof of Concept; evaluate new technological standards and its application on a day-to-day basis
Work closely with program/ project manager and workstream lead. 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 technical requirements are accurately interpreted and implemented
Act as a technical expert between business and Implementation partners.
Role Requirements:
Bachelor's degree in engineering or pharmaceutical discipline. An advanced degree (MBA, MS etc.) and related accreditations (TOFAF, Veeva, Data Management certifications etc.) is a plus
12+ years of IT solution architecting experience with excellent communication skills
Must have proven strong knowledge of SDLC, Validation & Compliance
Proficiency with tools such as Jira, Confluence, HPQC, modelling tools
Experience in Data migration and System integration related projects
Experience in managing GxP Projects and related fields (desirable)
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)
Desirable:
Technical Implementation experience of Veeva Submission and Registration module is a plus.
Language: English
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
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.
Skills Desired
Data Migration, Gxp, solution architect, The Open Group Architecture Framework (TOGAF), VeevaSimilar Jobs
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What We Do
Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
