Summary 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 skilled 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 As Associate Director - Service Delivery you will be responsible for leading and coordinating all phases of ongoing Veeva implementations The role collaborates with stakeholders manages vendor relationships communicates project status and ensures successful delivery through effective planning monitoring and issue resolution This role 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 About the Role Position Title Assoc Dir DDIT DEV RA BA Location - Hyd-India LI Hybrid 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 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 Support super user training 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 Work with Business and Process architecture teams to understand as-is and define to-be processes Desirable Requirements 13 years experience in SDLC system validation and Business Analyst role 5 years in Drug Development domain Implementation experience of Veeva RIM module is a plus Regulatory domain knowledge preferably Registration Information Management IDMP xEVMPD IDMP DADI HL7 EUDAMED I FHIR etc Proficiency with tools such as Jira Confluence Business process modelling tools Experience in Managing GxP Projects and Related Fields is a plus Ability to manage medium size teams as part of project execution Good negotiation and facilitation skills Ability to collaborate with a cross functional team on solution design Knowledge on business process modelling and canonical 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 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 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 Division Operations Business Unit Information Technology Location India Site Hyderabad Office Company Legal Entity IN10 FCRS IN010 Novartis Healthcare Private Limited Functional Area Technology Transformation Job Type Full time Employment Type Regular Shift Work No

📌 Associate Director Ddit Dev Ra (Telangana)
🏢 Novartis
📍 Telangana