Summary

Internal Role Title: Submission Readiness Document Manager Location: Hyderabad, India #LI-Hybrid About the Role: Clinical Document Governance Management (CDGM) is accountable for strategy and delivery of clinical document management (CDM) systems, processes, standards and operations of CDM services (including Trial Master File management (TMF), clinical submission readiness, record retention and archiving, Good Documentation Practice capability build) across Novartis globally. In addition, CDGM is driving the transformation of TMF at Novartis, through the introduction and adoption of new technologies, processes, and ways of working. The Submission Readiness Document Manager. Will be responsible for delivery and oversight of submission readiness of clinical documents, to support authoring and publishing of clinical documents required for regulatory submissions and achieve rapid, accurate and timely submissions to health authorities Drives implementation of CDGM initiatives, projects and process improvement activities to improve clinical document management systems, processes and standards at Novartis.

About the Role

• Responsible for efficient and appropriate management of submission-relevant documentation ((e.g., Protocol, CSR, ICF, PDR, etc.) for global clinical,) to meet electronic publishing requirements, Health Authority guidelines, Good Clinical Practices and Novartis SOPs.
• Support implementation of the submission document readiness management strategy for clinical documents and clinical documents templates.
• Develop and maintain submission readiness processes, contribute to or drive initiatives to improve and innovate business and technical aspects of submission readiness activities, in collaboration with other CDGM groups, business and IT Functions.
• Collaborate with cross-functional partners (e.g., Regulatory Writing & Submissions, Regulatory Affairs, Trial Management, etc.) on the planning, preparation, and delivery of high-quality documents within timelines, including expedited support for urgent requests to meet regulatory deadlines.
• Identifies and communicate processing risks/trends/patterns related to regulatory submission documents and works with key stakeholders to define and implement appropriate remediations.
• Serves as Subject Matter Expert on Regulatory Document Manager training materials, formal and informal processes and tracking tools for submission readiness oversight activities in collaboration with CDM Process team and other key partners
• Provides Audit/Inspection support, contributes to root cause analysis identification and creation/delivery of CAPAs.

Essential Requirements

• Proficient English (both spoken and written)
• Bachelor\xe2\x80\x99s degree or equivalent experience in life sciences/healthcare/pharmacy/information management and relevant proven experience.
• Detailed knowledge of clinical document management processes
• Sophisticated knowledge of clinical documentation standard methodology guidelines & principles (good documentation practice, data integrity)
• 3-5 years in clinical development/clinical operations or similar business area
• 2-3 years working experience with document management systems and excellent understanding of system structures and generic document management functionality
• Experience with project work or project management in a global, cross- functional multicultural and international matrix organisation
• Good understanding of technical processes and PC environment including Microsoft suite of products
• Sophisticated ability to work independently

Why Novartis? Our purpose is to reimagine medicine to improve and extend people\xe2\x80\x99s 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\xe2\x80\x99ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards 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

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\xe2\x80\x99 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


Division
Development
Business Unit
Innovative Medicines
Location
India
Site
Hyderabad (Office)
Company / Legal Entity
IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No


Novartis is committed to building an outstanding, inclusive work environment and diverse teams\' representative of the patients and communities we serve.