Job Description

20 years and 2 million-years of patient data waiting for you to unlock the next breakthrough in medicine. Bringing life-changing medicines to millions of people, Novartis sits at the intersection of cutting-edge medical science and innovative digital technology. As a global company, the resources and opportunities for growth and development are plentiful including global and local cross functional careers, a diverse learning suite of thousands of programs & an in-house marketplace for rotations & project work. With strong medicines pipeline our current transformation will not just deliver growth for our business but continue to allow us to bring innovative medicines to patients quickly. The job 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 GDD 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 Your responsibilities include but are not limited to: . 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. Stay up to date on the latest process and IT advancements to automate and modernize systems. . Analyses the business domain, documents its processes and systems in Novartis enterprise tool and outline business requirements. Coordinate and facilitate ongoing reviews of business processes ensuring security and compliance and developing optimization strategies . Ensure consistency and traceability between user requirements, functional specifications, and testing & validation. Support the validation and testing as appropriate and ensure adherence to Security and Compliance policies and procedures within Service Delivery scope. Keep abreast with internal IT systems and documentation requirements, standards (including quality management and IT security), regulatory environments / requirements (if applicable) . 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 Service Integrator documents the gaps, if any into the product backlog for prioritization and release planning. Guiding vendor and product teams to develop and release functionality that solves business critical problems . Point of contact to coordinate and support migration activities involving Business, Migration vendor and Product team and perform following tasks: o Logical mappings and gaps between source and target systems and update the mapping sheets o Define migration rules and support Business for enrichment activities o Define the criteria for flagging documents in scope of migration o Initiate discussions for business inputs to Migration vendor related to metadata, documents, rendition, and Audit Trail information for migration activities o Reviews migration specific documents like Migration plan, mapping sheets, enrichment sheets and test scripts by vendor and business Diversity & Inclusion / EEO Minimum Requirements What will you bring to the role 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 Business Analysis experience with minimum 3+ years of business analysis experience in Global Drug Development (preferably Regulatory affairs) and GxP environment . 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 (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 #transformingforgrowth Why Novartis 766 million lives were touched by Novartis medicines in 2021, and while we\'re proud of this, we know there is so much more we could do to help improve and extend people\'s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity, and flexibility. And we can reinvent what\'s possible, when we collaborate with courage to aggressively and ambitiously tackle the world\'s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! 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. 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:

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