IT Business Analyst - Regulatory Affairs

Role Title: IT Business Analyst - Regulatory Affairs
Location: Hyderabad

Key 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.

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.

Role Requirements :

Essential Requirements:

Education and Qualifications
• 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.

Experience
• 7+ years of IT Business Analysis experience.
• Implementation experience of Veeva Submission and Submission Archive module is a plus.
• 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, Product Labeling)
• Business analysis, requirements definition & management, analytical thinking, managing challenges, proactive thinking, effective communication, developing and delivering presentations
• Proficiency with tools such as Jira, Confluence, HPQC, Business process modeling tools
• Must have proven strong knowledge of SDLC, Validation & Compliance
• Should be self-motivated, take complete ownership for the tasks and drive to completion

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network