Sr. Business Analyst DDIT DEV RA

Job Description Summary

The primary objective of this position is to serve as a consultant and advisor, offering expert guidance to enhance complex business processes in Knowledge Management and Content Management in Regulatory Affairs leveraging the power of AI. We seek a seasoned professional with knowledge and expertise in the products and services developed globally to support the Regulatory Affairs function in Life Sciences Industry. This role brings in the expertise of AI assisted content generation, structured content authoring and automated content translation to support the business SMEs in enhancing the current processes and implementing the right fit IT solutions for the enhanced processes.

Job Description

Position Title: Sr. Business Analyst | DDIT DEV RA|

Location – Hyd-India #LI Hybrid

About the Role:

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 responsible for driving the discussions with product vendors for vendor selection, fit gap assessment along with refining the business requirements and configuration specifications to meet the business objectives. The Business Analyst is also actively involved supporting our inhouse Innovation teams in developing custom inhouse solutions as well as evaluating market offerings for GenAI based content generation and component based authoring solutions.  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

• Research and assessment of leading products and offerings from various solution providers in the areas of Knowledge Management, Structured Content Management and translation

• Analyze the regulations coming up in the Regulatory Affairs area in collaboration with the business SMES to determine the impact on existing business processes and IT system configurations  

• Work closely with business functions to identify AI opportunities, build business cases, and ensure AI investments deliver measurable business value.

• Develop a comprehensive requirement specification that will determine the estimate of cost, time and resources to implement new solutions for ensuring regulatory compliance.

• Support RFP process for vendor selection

• Liaise between product vendor and business stakeholders to finalize the functional scope

• Support in the development of project estimates and complete financial model (costs, savings, revenue opportunities, investment horizon, etc.)

What you'll bring to the role:

• 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)

• Take accountability to ensure adherence with Security and Compliance policies and procedures within Service Delivery scope

• Experience in Managing GxP Projects and Related Fields is a plus and ability to manage medium size teams as part of project execution. Knowledge on business process modelling and canonical

Desirable Requirements:

• Bachelor's degree in engineering, Computer Science/Information Technology,

• Min 10 years' experience in SDLC, system validation and Business Analyst role

• 5+ years in Drug Development domain and experience working in AI based solutions implementation for document generation, management

• Implementation experience of products in the Regulatory affairs area like, Veeva Vault, Documentum, Docuvera, Yseop etc.  

• Knowledge of component based structured authoring solutions

• Life sciences Regulatory domain knowledge

• 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.

Skills Desired

Analytical Thinking, Business Acumen, Communication Skills, Digital capabilities, Effective use of technology, Requirements Analysis, Requirements Gathering, Stakeholders Management

---