Technical design expert- gx Registration Management
- Hyderabad, India
530+ active trials with 80,000 patients; 9+ million case reports per year; 1 Regulatory submission every 6 minutes! As the technology and innovation Partner, Development IT supports every stage of drug development by delivering end-to-end service offerings. Join us and directly contribute to Novartis' vision to ReImagine Medicine.
Your responsibilities included but are not limited to :
• Play a key role in architecture designing and technical implementation of regulatory submission / document management solutions that deliver efficiencies for our business, enable global use of the regulatory submission / document management systems, and meet defined Novartis IT Security standards.
• Actively involved in creating the detailed IT solution/service design based on functional specifications, to meet quality and performance requirements and technical constraints. In this Position you will be working on global strategic initiatives within GxP compliant Regulatory environment.
• Create the detailed process designs necessary to operate the software/service on a day-to-day basis
• Ensure designs produced adhere to architectural roadmap and support the development, execution and operations of software/service
• Ensure 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
• Ensure the overall user experience is taken into account when designing new solutions and services
• Take accountability to ensure adherence with Security and Compliance policies and procedures within Service Delivery scope
• At least. 12- 16 year's experience in SDLC and system validation in highly regulated environment, ideally in Pharma industry - experience in Drug Regulatory Affairs domain.
• Experience in RIM (Regulatory Information Mgmt) business area would be considered as a big plus (i.e. managing complex Master Data Systems / Databases).
• Experience on Publishing / Submission Mgmt processes and tools (e.g. Lorenz docuBridge, eValidator, RSS, Insight Publisher, etc.) would be considered a big plus.
• Strong experience of eCTD (electronic Common Technical Document) specification. Open Text's Documentum, D2, and Life Science Suite software would be a plus.
• Strong experience architecting and implementing business, quality, and technical requirements for GxP systems
• Education: university degree equivalent to MS level in Computer or Life Sciences
Why consider Novartis?
799 million. That's how many lives our products touched in 2019. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
Imagine what you could do at Novartis!
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