Responsible for delivery and oversight
of CSR appendices authoring, formatting, compilation, and publishing required for regulatory submissions, achieving 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. 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.
Execute vendor oversight plan, monitor service metrics, and identify opportunities for improvement to the operating model. Act 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 work with key stakeholders to define and implement appropriate remediations.
Serve 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.
Provide Audit/Inspection support, contribute 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. #J-18808-Ljbffr
of CSR appendices authoring, formatting, compilation, and publishing required for regulatory submissions, achieving 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. 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.
Execute vendor oversight plan, monitor service metrics, and identify opportunities for improvement to the operating model. Act 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 work with key stakeholders to define and implement appropriate remediations.
Serve 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.
Provide Audit/Inspection support, contribute 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. #J-18808-Ljbffr
