The CSR Appendices Oversight Manager is responsible for managing and overseeing the authoring, formatting, and publishing of CSR appendices for regulatory submissions to health authorities. The role involves collaboration with cross-functional teams, ensuring compliance with guidelines, and driving process improvements in clinical document management.
Job Description Summary
Responsible for delivery and oversight of CSR appendices authoring, formatting, compilation and publishing 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 enhance clinical document management systems, processes and standards at Novartis.
This is a hybrid position based in either London or Dublin offices.
Job Description
Major accountabilities:
- Responsible for efficient and appropriate management, coordination and oversight of CSR appendices for assigned studies 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.
- Executes vendor oversight plan, monitors service metrics and identifies opportunities for improvement to the operating model. Acts as point of escalation for issues.
- 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.
- Identify and communicate processing risks/trends/patterns related to CSR appendices and works with key stakeholders to define and implement appropriate remediations.
- Serves as Subject Matter Expert on CSR appendices training materials, formal and informal processes, and tracking tools for CSR appendices 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.
Minimum Requirements:
- Bachelor’s degree in life-sciences/healthcare/pharmacy/information management and relevant industry experience.
- English fluency (written, oral) required.
- Thorough knowledge of clinical document management processes
- Advanced knowledge of clinical documentation practice guidelines & principles (Good Documentation Practice, Data integrity, ICH eCTD and FDA Portable Document formatting specifications (PDF) guidance)
- Experience of authoring, compilation and formatting of CSR appendices according to ICH E3
- 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 organization
- Excellent communication, organization and tracking skills
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Skills Desired
Budget Management, Clinical Trials, Negotiation Skills, People Management, Process Improvement, Project Planning, Vendor Management, Waterfall Model
Novartis London, England Office
The WestWorks, White City Place, London, United Kingdom, W12 7FQ
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