Periodic Reporting Manager

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.

Daily activities:

• 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.

About you

Education

• Bachelor’s degree in Computer Science, Life Science or related field, preferred.

Experience

• Minimum 5 years of pharmaceutical industry experience in post marketing reporting.

• Strong regulatory knowledge is required.

Technical Skills & Soft skills:

• 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.

Why Choose Us

• Bring the miracles of science to life alongside a supportive, futurefocused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.

• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

• Help improve the lives of millions of people globally by making drugdevelopment quicker and more effective.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.