Snr Business Analyst, Ddit Dev. Regulatory Affairs
hace 6 días
Snr Business Analyst, DDIT Dev.
Regulatory Affairs Job ID REQ-10033824 Location: Spain Summary This role's 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 redefine how Novartis operates.
You will be working on strategic initiatives with the mandate to deliver solutions that will bring transformative change to the business domain and allow Novartis to realize a competitive advantage.
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.
Analyze 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 validation and testing as appropriate.
Work closely with Project Manager and workstream leads.
Collaborate 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 vendors, Novartis internal IT teams, and business to ensure documentation is at the appropriate level of detail and that the requirements are accurately interpreted and implemented.
Act as an 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.
Proven strong knowledge of SDLC, Validation & Compliance.
Proficiency with tools such as Jira, Confluence, HPQC, and business process modeling 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, 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.
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 a Company Pension plan; Life and Accidental Insurance; Meals; Allowance or Canteen in the office; Flexible working hours.
Commitment to Diversity & Inclusion: Novartis is 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 to achieve breakthroughs that change patients' lives.
Ready to create a brighter future together?
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.
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Snr Business Analyst, Ddit Dev. Regulatory Affairs
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Barcelona, España Novartis Farmacéutica A tiempo completo.Snr Business Analyst, DDIT Dev. Regulatory Affairs Job ID REQ-10033824Location: SpainSummary This role's 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...
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