Job Description Summary
- Senior Specialist for project delivery and / or operations in the given business sub-capability. Partner with Business Stakeholders and TT Strategic Business Partners for demand analysis, solution proposal / evaluation and project delivery.
Job Description
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 projectsHighlight / identify gaps in existing functionality and review requirements with stakeholdersDevelop a comprehensive requirement specifications that will determine the estimate of cost, time and resources to deploy solutionsLiaise 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 servicesEnsure the overall user experience is taken into account when designing and deploying new solutions and servicesEnsure 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” processesSupport 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 scopeWhat 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 executionExpert understanding of business process analysis & design and system architecture conceptsGood negotiation and facilitation skills and Ability to collaborate with a cross functional team on solution designProven experience analyzing business needs, eliciting and documenting effective user requirements for GxP systemKnowledge on business process modelling and canonical, Excellent verbal and written communication skills in English. Experience working with global teamsDesirable 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 toolsCommitment 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.
Skills Desired
Budget Management, Business Acumen, Influencing Skills, Performance Management, Risk Management, Service Delivery Management, Strategic Planning, Waterfall Model