Sr. Business Analyst DDIT DEV RA

Position Title: Sr. Business Analyst DDIT DEV RA

Location – Hyd-India #LI Hybrid

Role Purpose

The primary objective of this position is to serve as a consultant and advisor, offering expert guidance to enhance complex global business processes, products, and services in Regulatory Affairs. We seek a seasoned professional in GDD Regulatory Affairs who will lead both the strategic and operational implementation of Veeva Vault capabilities for Regulatory Registration Module. This role is responsible for ensuring alignment with organizational objectives, regulatory requirements, and enterprise architecture standards, whilst promoting product innovation and managing the lifecycle.

The Business Analyst has a key role in describing and translating business requirements in a way that they are clear, complete and easily understood by the business and other relevant stakeholders. The Business Analyst is actively involved in pre-project discussions, solution design discussions, to ensure the implementation fulfills the business requirements with a key focus on purpose, consistence and usability. Good technical background in conjunction with proven business analysis techniques and well developed interpersonal skills are key success factor in this role.

Your responsibilities include but are not limited to

• Develop project rationale and perform scoping assessments to determine feasibility of projects
• Highlight/identify gaps in existing functionality and review requirements with stakeholders
• Develop a comprehensive requirement specifications that will determine the estimate of cost, time and resources to deploy solutions
• Liaise with the service development team to suggest a high level functional solution and support in the development of project estimates and complete financial model (costs, savings, revenue opportunities, investment horizon, etc.)
• Ensure that relevant stakeholders are involved in specification of new services and/or major upgrades to existing services
• Ensure the overall user experience is taken into account when designing and deploying new solutions and services
• Ensure consistency and traceability between user requirements, functional specifications and testing & validation. Support validation and testing (OQ, PQ, UAT...)
• Ensure implemented solutions are according to specifications and fit for purpose and Work with Business and Process architecture teams to understand “as-is” and define “to-be” processes
• Support super user training and Keep abreast with internal IT systems and documentation requirements, standards (including quality management and IT security)
• Keep abreast with industry best practices in leveraging technologies for the business and with regulatory environments / requirements if applicable.
• Take accountability to ensure adherence with Security and Compliance policies and procedures within Service Delivery scope

What you’ll bring to the role:

• Experience in Managing GxP Projects and Related Fields is a plus. Ability to manage medium size teams as part of project execution
• Expert understanding of business process analysis & design and system architecture concepts
• Good negotiation and facilitation skills and Ability to collaborate with a cross functional team on solution design
• Proven experience analyzing business needs, eliciting and documenting effective user requirements for GxP system
• Knowledge on business process modelling and canonical, Excellent verbal and written communication skills in English. Experience working with global teams

Desirable Requirements:

• Bachelor’s or master’s degree in computer science, Engineering, Business, or related field.

• 8 + years’ experience in SDLC, system validation and Business Analyst role and 5+ years in Drug Development domain. Implementation experience of Veeva RIM module is a plus.
• Regulatory domain knowledge (preferably Registration Information Management, IDMP, xEVMPD etc.). Proficiency with tools such as Jira, Confluence, Business process modelling tools

Commitment to Diversity & Inclusion:

Novartis embraces diversity, equal opportunity, and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

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

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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards