Lead, R&D Document Standards & Integrated Services

Lead, R&D Document Standards & Integrated Services Location: Morristown, NJ / Cambridge, MA About the Job As Lead, R&D Document Standards & Integrated Services, you will drive operational excellence across Sanofi’s R&D organization for document authoring and standardization. You will collaborate with global teams—including our Hyderabad Hub—to revamp document management processes, evaluate and integrate improved technology, and lead continuous improvement initiatives. Main Responsibilities Define and own the long‑term strategy for document standards, template governance, and submission‑ready authoring across global R&D. Standardize the preparation of regulatory documents (NDA, MAA, IND, BLA, CTD) to meet regional and global Health Authority requirements. Establish and lead a unified governance and quality control model for R&D document templates, including review cadence, approval workflows, and access controls. Develop, version, and maintain Operational Procedures for template governance in line with GxP and regulatory standards. Drive continuous optimization of the template library to ensure efficiency, compliance, and alignment with evolving Health Authority requirements. Represent the Submission & Document Services Platform in governance committees and cross‑functional initiatives, advocating for process optimization and standardization. Lead the rationalization and harmonization of document templates across R&D to maintain a lean, well‑governed library. Establish a single source of truth for formatting standards and ensure consistent visual identity across all R&D dossiers. Lead cross‑functional working groups (Clinical, Nonclinical, Regulatory, Quality, PSPV) to drive alignment and continuous improvement. Partner with Digital to manage style assets and ensure seamless author access to formatting standards. Create, maintain, and monitor dashboards that track operational metrics and provide visibility to leadership. Develop standardized document preparation workflows for multiple regulatory jurisdictions and implement submission readiness checklists. Partner with eGSM, Digital, and DDAI to evaluate, recommend, and implement tools and technologies that improve document authoring, including AI‑enabled and automation solutions. Ensure standardized templates and tooling enable GenAI‑assisted authoring and integrate with the broader R&D technology ecosystem. Maintain awareness of the regulatory technology landscape, identify modernization opportunities, and champion solutions for end‑to‑end submission readiness. Strategically lead cross‑functional stakeholders to ensure process alignment, integration, and adoption of the new model. Build and maintain strong relationships across the R&D authoring community to sustain onboarding and adoption of standardized processes and tools. Design and deploy change management strategies and training programs supporting authors through process and technology transitions. Develop communication strategies to keep stakeholders informed about standards updates, resources, and process improvements. Facilitate collaboration among global teams, including the Hyderabad Hub and Digital partners. Align document preparation timelines with submission planning milestones in collaboration with Regulatory Operations and submission project managers. Qualifications Bachelor’s degree in regulatory affairs, sciences, related area, or equivalent experience; Master’s preferred. Minimum of 8 years of experience in pharmaceutical document management or regulatory operations with a proven background in process optimization, continuous improvement, and cross‑functional program leadership. Proficiency with document management software and tools (EDMS, Adobe Acrobat, Office Suite, Veeva Vault RIM). Understanding of eCTD submission standards; knowledge of regulatory Information Management systems highly valued. Excellent verbal and written communication skills and strong decision‑making ability with an analytical approach to problem‑solving. Ability to manage simultaneous priorities, coordinate complex projects in a matrix environment, and identify process inefficiencies with practical solutions. Adaptability and flexibility to work in a fast‑changing, innovation‑driven environment. Proficiency in English (verbal and written). Benefits Competitive salary range: $148,500.00 – $214,500.00, paid commensurate with experience. Access to a comprehensive benefits package, including high‑quality health and wellness programs. At least 14 weeks of gender‑neutral parental leave. Opportunities for professional growth, promotion, and lateral moves both domestically and internationally. Supportive, future‑focused team culture that values innovation and collaboration. Equal Employment Opportunity 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, marriage, domestic partnership, civil union status, sex, gender identity or expression, affliction, sexual orientation, disability, veteran or military status, or any protected characteristic of law. #J-18808-Ljbffr Sanofi