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. This role combines strong analytical skills with excellent cross‑functional collaboration abilities to deliver high‑quality results in a fast‑paced environment. You will also contribute to continuous learning and innovation, particularly in the areas of AI and clinical study data management. 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 recommend remediation strategies aimed at reducing error rates. Provide high‑quality preparation of AR /AR Amendment/PADER contributions and assist in the 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 and experience requirements are detailed below. 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. Benefits Supportive, future‑focused team. Ongoing opportunities to grow your talent and drive your career, whether through a promotion or lateral move, at home or internationally. Thoughtful, well‑crafted rewards package that recognizes your contribution and amplifies your impact. Wide range of health and well‑being benefits including high‑quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender‑neutral parental leave. Opportunity to be part of a pioneering biopharma company engaging patients early and using their insights. Frontier of drug discovery with cutting‑edge AI, data, and digital platforms. Help improve the lives of millions globally by expediting drug development. EEO Statement 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. Compensation & Benefits 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. #J-18808-Ljbffr Sanofi