Sanofi
biopharma
PeriodicReportingManager
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“Periodic Reporting Manager at Sanofi. Skills: Periodic Reporting, Regulatory Compliance, Document Management. managing and coordinating periodic reporting initiatives. ensuring compliance with regulatory requirements”
What You'll Achieve.
deliver high-quality results; enhance reporting efficiency and quality control; reducing error rates; improving the lives of millions of people globally by making drug development quicker and more effective
Industry & Context.
analytical skills; Track and analyze errors to identify root causes and to recommend remediation strategies aimed at reducing error rates
What They're Looking For.
Must Have
Minimum 5 years of pharmaceutical industry experience in post marketing reporting, regulatory knowledge is required
Nice to Have
Project management across multiple projects
What You'll Do.
managing and coordinating periodic reporting initiatives
ensuring compliance with regulatory requirements
timely submission of critical regulatory documents
preparation and review of Annual Reports (AR)
Annual Report amendments
Periodic Adverse Drug Events Reports (PADER)
other required regulatory documents
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
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
How You'll Work.
Team & Collaboration
excellent cross-functional collaboration abilities; Manage cross-functional collaborations to gather, analyze, and compile post-marketing reporting data
Process & Methodology
Project management across multiple projects
Full Job Description
**Job title:** Periodic Reporting Manager * **Location:** Cambridge, MA **About the job** 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. Responsible for preparation and review of Annual Reports (AR), Annual Report amendments, Periodic Adverse Drug Events Reports (PADER), and other required regulatory documents. Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. **About Sanofi** We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. **Main 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. **D
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