Summary
Responsible for detailed design, development, and delivery of system solutions for Regulatory Affairs (RA). You will engage with global business leaders and leverage the appropriate IT teams and Functions to determine requirements and deliver data-driven recommendations to improve efficiency and add value.
About the Role
Position Title: Assoc. Dir. DDIT DEV RA Sol. Del.
Location – Hyd-India #LI Hybrid
About the Role
As Assoc. Dir. DDIT DEV RA TD you will create the detailed IT solution/service design, based on functional specifications to meet quality and performance requirements and technical constraints.
Responsible for detailed design, development, and delivery of system solutions for Regulatory Affairs (RA). You will engage with global business leaders and leverage the appropriate IT teams and Functions to determine requirements and deliver data-driven recommendations to improve efficiency and add value.
Your responsibilities include but are not limited to
- Responsible for detailed design, development and delivery of system solutions for Regulatory Affairs area, in alignment defined solution architecture and create the detailed process designs necessary to operate the software/service on a day-to-day basis.
- Take accountability for delivery of projects / use cases for a specific business or technology area.
- Lead investigation and troubleshooting on critical RA application issues, coordinate with different teams to get desired results.
- Ensure designs produced adhere to architectural roadmap and support the development, execution, and operations of software/service.
- Collaborating across boundaries, Project Management, People Leadership, Ability to work and lead (a cross-functional team) in a matrix environment.
- Ensure peer review and sign off detailed designs by business and that detailed designs adhere to solution architecture design (i.e. high level conceptual design) and are traceable to functional as well as non-functional requirements in functional specification.
- Take accountability to ensure adherence with Security & Compliance policies and procedures within Service Delivery scope
What you’ll bring to the role:
- Successful delivery and operations of standardized IT solutions for the Novartis RA line functions that are well aligned to the business strategy and global IT Strategy.
- Key performance indicators which are relevant for customer satisfaction are clearly defined, constantly measured, and met.
- User experience and service performance acceptance from end users, measured through end user satisfaction survey
- Nice to have - Working knowledge of Project Management; experience with Agile methodologies is an added advantage. innovation initiatives including digital innovation projects (e.g., **GenAI**), data strategy, data science, or data standardization.
Desirable Requirements:
- Bachelor’s degree in computer science, Computer Engineering or related technical discipline or equivalent experience demonstrated
- 12+ years of experience in the Pharma or IT industry, including several years in the RA IT domain, with hands-on experience in RA applications and technologies (preferred: Veeva Vault RIM).
- Expert understanding of analysis & design and system architecture concepts. RA business processes an advantage. Good knowledge of GXP, 21CFR Part 11 and the CSV lifecycle
- Prior working experience in RA and knowledge on RA business processes is preferred. Ability to solve complex business process / information challenges.
Why Novartis:
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:
https://www.novartis.com/about/strategy/people-and-culture
You’ll receive
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
Commitment to Diversity and 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: https://talentnetwork.novartis.com/network
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
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)