Job Description

Join to apply for the CSR Appendices Oversight Manager role at Novartis

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Join to apply for the CSR Appendices Oversight Manager role at Novartis

Summary

This position will be located at East Hanover, NJ site and will not have the ability to be located remotely.

Note: Please note that this role does not provide relocation support; only local candidates will be considered.

Responsibilities include delivery and oversight of CSR appendices authoring, formatting, compilation, and publishing required for regulatory submissions, ensuring rapid, accurate, and timely submissions to health authorities.

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

Key Responsibilities

1. Manage, coordinate, and oversee CSR appendices for assigned studies to meet electronic publishing requirements, Health Authority guidelines, Good Clinical Practices, and Novartis SOPs.


2. Support implementation of the submission document readiness management strategy for clinical documents and templates.


3. Execute vendor oversight plans, monitor service metrics, and identify opportunities for improvement, acting as a point of escalation for issues.


4. Develop and maintain submission readiness processes, and collaborate with other groups to improve and innovate submission activities.


5. Collaborate with cross-functional stakeholders on planning, preparation, and delivery of high-quality documents within timelines, including urgent requests.


6. Identify and communicate processing risks/trends related to CSR appendices and work with stakeholders on remediations.


7. Serve as Subject Matter Expert on CSR appendices training materials, processes, and tracking tools.


8. Provide support for audits/inspections and contribute to root cause analysis and CAPA creation.

Requirements

• Bachelors degree in life sciences, healthcare, pharmacy, or information management, with relevant industry experience.


• Thorough knowledge of clinical document management processes.


• Advanced knowledge of clinical documentation guidelines (GDP, Data integrity, ICH eCTD, FDA PDF guidance).


• Experience authoring, compiling, and formatting CSR appendices according to ICH E3.


• Minimum of 5 years in clinical development/operations or similar.

Preferred

• Experience with document management systems and understanding of system structures.


• Good understanding of technical processes and proficiency with Microsoft Office.

Compensation and Benefits: The salary range at start is expected to be $114,100 - $195,600/year. Final pay depends on various factors. Benefits include bonuses, stock units, awards, and comprehensive health and retirement plans. Details will be provided upon offer.

Note: This role does not offer relocation support; only local candidates should apply.

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EEO & Accessibility

Novartis is an equal opportunity employer and committed to providing reasonable accommodations for individuals with disabilities. Contact: email@novartis.com or call +1(877)395-2339, including the job requisition number.

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