Sanofi

biopharma

PeriodicReportingManager

$122–177k Cambridge, Massachusetts, United States; Somerville, Massachusetts, United States; Hyde Park, Massachusetts, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid candidates.

The Brief

“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.

biopharma
Problems you'll solve

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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