Snr Specialist, IT Business Analyst, Technical Design (Regulatory Affairs)

Novartis Farmacéutica; Barcelona; Presencial; EUR 55.000 - 85.000; Jornada completa

Descripción de la vacante

Novartis is seeking a Snr Specialist, IT Business Analyst in Barcelona to lead business analysis for Global Drug Development Regulatory Affairs. This role involves engaging with stakeholders to improve efficiency and enable transformative business changes. The ideal candidate will possess extensive experience in IT business analysis and a strong knowledge of regulatory affairs.

Servicios

Company Pension plan

Life and Accidental Insurance

Meals allowance

Canteen in the office

Flexible working hours

Formación

• 7+ years of IT Business Analysis experience required.
• Proven strong knowledge of SDLC, Validation & Compliance essential.
• Experience in Regulatory Affairs business processes is a plus.

Responsabilidades

• Engage with global business associates to determine requirements and deliver recommendations.
• Analyze the business domain and author business requirements.
• Coordinate and facilitate ongoing reviews of business processes.

Conocimientos

Communication

Business Analysis

Stakeholder Management

Data Migration

System Integration

Regulatory Affairs Process Knowledge

Educación

Bachelor's degree in engineering or pharmaceutical discipline

MBA or MS

Related accreditations (IIBA, Veeva, Agile)

Herramientas

Jira

Confluence

HPQC

Business Process Modelling Tools

Descripción del empleo

Snr Specialist, IT Business Analyst, Technical Design (Regulatory Affairs)

Job ID REQ-10018835

Aug 13, 2024

Spain

Summary

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 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