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.

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.

The salary range for this position is:
$148,500.00 - $214,500.00

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.