CSR Appendices Oversight Manager

About the Role

Key Responsibilities

• 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) on 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, and 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, and create/deliver CAPAs.

Requirements

• Bachelor's degree in life sciences, healthcare, pharmacy, or information management and relevant industry experience.
• 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).
• Experience of authoring, compilation, and formatting of CSR appendices according to ICH E3.
• Minimum of 5 years in clinical development/clinical operations or similar business area.
• Prior experience with document management systems and understanding of system structures and document management functionality.
• Good understanding of technical processes and PC environment including Microsoft suite of products.

Nice to Have

• Experience with system structures and generic document management functionality.

Qualifications

• Bachelor's degree in life sciences, healthcare, pharmacy, or information management.
• Relevant industry experience.

Benefits & Perks

• The total compensation package may include a sign-on bonus, restricted stock units, and discretionary awards.
• Full range of medical, financial, and/or other benefits including 401(k) eligibility and paid time off benefits such as vacation, sick time, and parental leave.
• Salary range expected to be between $114,100 and $195,600/year, with potential adjustments based on various factors.