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 submission readiness of clinical documents: authoring, formatting, and publishing clinical documents required for regulatory submissions to support rapid, accurate and timely submissions to health authorities.

　　Drives implementation of CDGM initiatives, projects and process improvement activities to enhance clinical document management systems, processes and standards at Novartis.

　　Main accountabilities:

　　• 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 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 stakeholders

　　• Provides Audit/Inspection support, contributes to root cause analysis identification and creation/delivery of CAPAs.

　　Diversity & Inclusion / EEO

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

　　Role Requirements

　　• Bachelor's degree in life sciences/healthcare/pharmacy/information management and relevant industry experience.

　　Thorough knowledge of clinical document management processes

　　• Advanced knowledge of clinical documentation best practice 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

　　• Good understanding of technical processes and PC environment including Microsoft suite of products

　　• Advanced ability to work independently

　　• Experience with project work or project management in a global, cross- functional multicultural and international matrix organisation

　　#GCO

　　#CDGM

　　You'll receive:

　　Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 25 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.

　　(please note: applicable to Ireland, compensation varies in UK)

　　Why consider Novartis?

　　736 million. That's how many lives our products touched in 2022. 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!

　　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

　　Novartis Ireland Ltd. has been certified as a Top Employer 2022 by the Top Employers Institute for its exceptional employee offerings!

　　Division

　　Development

　　Business Unit

　　GCO GDD

　　Location

　　Ireland

　　Site

　　Dublin

　　Company / Legal Entity

　　Novartis Ireland Limited

　　Alternative Location 1

　　United Kingdom

　　Alternative Location 2

　　India

　　Functional Area

　　Research & Development

　　Job Type

　　Full Time

　　Employment Type

　　Regular

　　Shift Work

　　No