Snr Specialist, IT Business Analyst, Technical Design (Regulatory Affairs)
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Role Overview
This role's purpose is to act as a consultant and advisor, providing guidance to improve complex global business processes, products, and services. We seek an experienced individual in Global Drug Development Regulatory Affairs to lead business analysis activities that will redefine how Novartis operates.
You will work on strategic initiatives aimed at delivering transformative solutions, granting Novartis a competitive advantage.
Responsibilities
1. Engage with global business associates, leveraging appropriate teams to determine requirements and deliver data-driven recommendations for efficiency and value addition.
2. Analyze the business domain, author requirements, and coordinate reviews of business processes.
3. Ensure traceability between requirements, specifications, and testing; support validation and testing processes.
4. Identify issues, changes, and risks; collaborate with project teams and participate in sprint planning to ensure deliverables are on track.
5. Coordinate with vendors and internal teams to ensure documentation accuracy and requirement implementation.
6. Act as an interface between business and implementation partners, reviewing demos and documenting gaps.
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 strong communication skills.
* Proven knowledge of SDLC, Validation & Compliance.
* Proficiency with tools like Jira, Confluence, HPQC, and business process modeling tools.
* Experience in data migration and system integration projects.
* Global experience, interacting with senior management and influencing across boundaries.
* Experience in Regulatory Affairs processes is advantageous.
Desirable Skills
* Experience with Veeva Submission modules.
* Managing GxP projects and related fields.
Language: English
Location: Barcelona, Spain (relocation support not provided)
Benefits & Rewards
Includes pension, insurance, meals, flexible hours, and more. Details available in the Novartis Life Handbook.
Our Commitment
We value diversity and inclusion, aiming to build an inclusive environment reflective of our communities.
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