Lead, R&D Document Standards & Integrated Services

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* Job title:

** Lead, R&D Document Standards & Integrated Services

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* Location:

** Morristown, NJ / Cambridge, MA

** About the job*
* As  
** Lead, R&D Document Standards & Integrated Services
** within our  
** R&D team** , you will be part of our Submission & Document Services Platform that supports critical regulatory submissions across Sanofi's portfolio. In this role, you will be responsible for driving operational excellence across the R&D organization for document authoring and standardization efforts.

Based in the US, you will work closely with our global teams, including our Hyderabad Hub, colleagues throughout R&D, and the Digital organization to revamp our document management business processes, evaluate and integrate improved technology for R&D authoring, and drive continuous improvement initiatives. This role is pivotal in streamlining workstream management for R&D activities in support of eCTD acceleration and harmonization while ensuring cross-functional collaboration and operational efficiency across our global operations.

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*
* Strategic Leadership & Governance

+ Define and own the long-term strategy for all document standards, template governance, and submission-ready authoring across the global organization encompassing all

+ R&D Authoring functions

+ Standardize the preparation of documents intended for regulatory submission, ensuring alignment with regional and global Health Authority requirements across all submission types (e.g., NDA, MAA, IND, BLA, CTD)

+ Establish and lead a singular governance and quality control model for R&D encompassing document templates, including review cadence, approval workflows, and access controls to ensure quality at the source

+ Develop, version, and maintain Operational Procedures (OPEs) for template governance in alignment with GxP and regulatory standards

+ Drive continuous optimization of the template library to ensure efficiency, compliance, and alignment with evolving Health Authority requirements

+ Define and enforce clear template ownership, accountability, and maintenance responsibilities across various functions within R&D - including clinical, non-clinical, pharmacovigilance, regulatory and CMC.

+ Represent the Submission & Document Services Platform in governance committees and cross-functional initiatives, advocating for process optimization and standardization

Operational Excellence & Standardization

+ Lead the ongoing rationalization and harmonization of document templates across R&D ensuring a lean, well-governed, and consistently maintained library of documentation required for dossier submission.

+ Establish and sustain a single source of truth for formatting standards, ensuring consistent visual identity and style application across all R&D dossiers and authoring platforms

+ Lead cross-functional working groups - spanning Clinical, Nonclinical, Regulatory/Labeling, Quality, and PSPV - to drive workstream-specific alignment and continuous improvement

+ Partner with Digital in the management of style assets (including but not limited to .dot files and toolbar plug-ins) to ensure seamless author access and adherence to formatting standards

+ Create, maintain and monitor dashboards to track operational metrics and provide ongoing visibility to leadership on program health and performance

+ Develop and maintain standardized document preparation workflows specifically designed to meet submission requirements across multiple regulatory jurisdictions (e.g., FDA, EMA, PMDA, Health Canada, etc.)

+ Implement submission readiness checklists and quality review processes within Global Submissions management to ensure documents meet formatting, content, and structural requirements prior to dossier compilation

Technology Integration & Innovation

+ Partner with the eGSM lead, Digital and DDAI to evaluate, recommend, and implement tools and technologies that improve the efficiency and quality of document authoring and submission preparation, including AI-enabled and automation solutions

+ Ensure standardized templates and tooling serve as foundational enablers for the transition to GenAI-assisted authoring

+ Maintain awareness of the evolving regulatory technology landscape and proactively identify opportunities to modernize authoring and submission workflows

+ Partner with DDAI and Digital to integrate document standards capabilities into the broader R&D technology ecosystem

+ Evaluate and…