Summary
About the Role
Reporting to the CDM Submission Readiness Team Lead, the 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.
Key responsibilities:
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 stakeholders (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 remediation.
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 stakeholders
Provides Audit/Inspection support, contributes to root cause analysis identification and creation/delivery of CAPAs.
Role Requirements:
Fluent English (both spoken and written)
Bachelor’s degree in life sciences / healthcare / pharmacy / information management.
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 organization
Thorough knowledge of clinical document management processes
Advanced knowledge of clinical documentation best practice guidelines & principles (good documentation practice, data integrity)
Good understanding of technical processes and PC environment including Microsoft suite of products
Skills:
Advanced ability to work independently
Agility
Collaboration
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
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
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn 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’ 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
