Lead, R&D Document Standards & Integrated Services

Job title: Lead, R&D Document Standards & Integrated Services 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 champion technology solutions that support end-to-end submission readiness, including document assembly, publishing, and electronic submission tools (e.g., eCTD) Stakeholder Collaboration & Change Management Strategically lead cross-functional stakeholders — including Clinical, Nonclinical, PSPV, M&S / CMC, and GRA — to ensure process alignment, integration, adoption of the new model Build and maintain strong relationships across the R&D authoring community to drive sustained onboarding and adoption of standardized processes and tools Design and deploy change management strategies and training programs that support authors through process and technology transitions Develop communication strategies to ensure stakeholders are continuously informed about standards updates, available resources, and process improvements Facilitate collaboration among global teams, including the Hyderabad Hub and Digital organization partners Contribute to specification mapping, transition planning, and Business as Usual (BAU) requirements for process integration Partner with Regulatory Operations and submission project managers to align document preparation timelines with submission planning milestones About you Education Bachelor’s degree or equivalent degree in regulatory affairs, sciences, related areas of study and/or relevant experience. Master's degree, preferred. Experience Minimum of 8 years of experience in pharmaceutical document management or regulatory operations, with demonstrated background in process optimization, continuous improvement methodologies, and cross-functional program leadership. Soft, digital and technical skills Proficiency with document management software and tools, such as electronic document management systems (EDMS), Adobe Acrobat, Microsoft Office Suite, Veeva Vault RIM Understanding of eCTD submission standards required; understanding of regulatory Information Management systems is highly valued. Excellent verbal and written communication skills to effectively collaborate with multiple levels in the organization Strong decision-making abilities with analytical approach to problem-solving. Ability to manage simultaneous priorities and coordinate complex projects in a matrix environment Demonstrated capacity to identify process inefficiencies and propose practical solutions Strong decision-making abilities with an analytical approach to problem-solving Strong analytical skills with the ability to translate data into actionable insights Adaptability and flexibility to work in a fast-changing, innovation-driven environment Ability to manage simultaneous priorities and coordinate complex, multi-workstream programs in a global matrix environment Languages English language proficiency required (verbal and written) 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 drug development quicker and more effective. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affimative 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. 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