Snr Specialist, IT Business Analyst, Technical Design (Regulatory Affairs) Job ID : REQ-10018835
Aug 13, 2024
Location : Spain
Summary: This role is to act as a consultant and advisor, providing guidance to improve complex global business processes, products, and services. We are seeking an experienced individual in Global Drug Development Regulatory Affairs to lead business analysis activities for solutions that will redefine how Novartis operates.
You will work on strategic initiatives with the mandate to deliver solutions that will bring transformative change to the business domain, enabling Novartis to gain a competitive advantage.
Role Responsibilities:
* Engage with global business associates and leverage appropriate teams to determine requirements and deliver data-driven recommendations for efficiency and value addition.
* Analyze the business domain and author business requirements. Coordinate and facilitate reviews of business processes.
* Ensure consistency and traceability between user requirements, functional specifications, and testing & validation. Support validation and testing as needed.
* Flag issues, changes, or risks to the Project Manager and workstream leads. Collaborate with product squads to deliver the product roadmap. Participate in sprint planning and ensure deliverables are on track.
* Liaise with vendors, internal IT teams, and business units to ensure documentation is detailed and requirements are accurately interpreted and implemented.
* Act as an interface between business and implementation partners. Review sprint demos and document gaps.
Role Requirements:
* Bachelor's degree in engineering or pharmaceutical discipline; advanced degrees and certifications (e.g., MBA, MS, IIBA, Veeva, Agile) are a plus.
* 7+ years of IT Business Analysis experience with excellent communication skills.
* 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 projects.
* Global experience interacting with senior management and collaborating across boundaries.
* Experience in Regulatory Affairs processes (e.g., Registration, Submission Management, Content Management, Publishing) is advantageous.
* Experience with Veeva Submission modules and GxP projects is a plus.
Benefits & Rewards: Our handbook details how we support your personal and professional growth. Benefits in Spain include a company pension plan, life and accidental insurance, meals or canteen access, and flexible working hours.
Commitment to Diversity & Inclusion: We strive to build an inclusive, diverse work environment reflecting the communities we serve.
This role is based in Barcelona, Spain. Please only apply if this location is accessible to you, as we do not offer relocation support.
Why Novartis: Helping people with disease requires innovative science and a passionate community. Join us to collaborate, support, and achieve breakthroughs that change lives.
#J-18808-Ljbffr