Periodic Reporting Manager

About the role

As Periodic Reporting Manager, you will be responsible for managing and coordinating periodic reporting initiatives across Sanofi, ensuring compliance with regulatory requirements and timely submission of critical regulatory documents. Combines strong analytical skills with excellent cross-functional collaboration abilities to deliver high-quality results in a fast-paced environment. Committed to continuous learning and innovation, particularly in the areas of AI and clinical study data management.

Responsibilities

• Ensure timely delivery and compliance with regulatory requirements for Annual Reports (AR), Periodic Adverse (Drug) Events Reports (PADER/PAER), Addendum to Clinical Overview (ACO) publishing, and other regulatory documents as needed.
• Manage cross-functional collaborations to gather, analyze, and compile post-marketing reporting data while implementing process improvements that enhance reporting efficiency and quality control.
• Perform comprehensive quality assessment of regulatory documents, ensuring proper study classification, accurate documentation, and validation of all contributions to FDA submissions.
• Identify reportable studies and assemble data for submission to the FDA.
• Track and analyze errors to identify root causes and to recommend remediation strategies aimed at reducing error rates.
• Provide high quality preparation of AR /AR Amendment/PADER contributions and assist in execution of the process for generating these documents.
• Contribute to the development and implementation of processes for preparation of periodic reporting documents.
• Conduct QC review for Annual Reports & PADERs prepared by colleagues. Ensuring compliance with all applicable SOPs, Federal Guidelines and Regulations.
• Use Sanofi databases and tracking tools for reporting study/program progress.

Requirements

• Minimum 5 years of pharmaceutical industry experience in post marketing reporting.
• Strong regulatory knowledge is required.
• Proficiency with Microsoft Project, Microsoft Office Suite including SharePoint, Word, Excel, PowerPoint, and Adobe Acrobat.
• Knowledge of Good Clinical Practices, Corporate policies and standard operating procedures.
• Project management across multiple projects, preferred.
• Excellent attention to detail.
• Excellent time management.