Documentation Specialist

About the role

The Documentation Management function sits within the Quality System job family, specifically under the Quality Content Management System (CMS), Quality Systems. This team is part of the broader Quality organization that covers Quality Control, Quality Audit, Regulatory Compliance, and Quality Risk Management. The Documentation Management team is responsible for managing the lifecycle of Quality documents and records in compliance with good documentation practices, keeping documentation current, optimizing and simplifying it to ensure Sanofi compliance with regulations, and facilitating record retention and archiving procedures on behalf of the Swiftwater entity.

Responsibilities

• Manage the GxP documentation lifecycle (creation, revision, and obsolescence)
• Collaborate with other departments to ensure document content addresses business needs and processes
• Ensure, with the support of relevant experts, that documentation content is compliant with regulatory requirements and company standards
• Maintain a lean overall documentation package by avoiding redundancies and duplication
• Ensure accuracy, completeness, and compliance of documentation with writing rules (including clarity and grammar)
• Collect needs for documentation changes, prioritize and manage document updates
• Ensure documentation is regularly updated to remain current and aligned with needs and processes
• Ensure document distribution and access complies with the information classification level
• Support internal and external audits and inspections by ensuring all required documents are up-to-date and retrievable
• Act as Business Archives Coordinator (BAC) on behalf of the Swiftwater site, supporting record retention archiving procedures
• Act as liaison with approved third-party storage subcontractors
• Provide guidance on archiving tools and processes
• Support annual archival eligibility reviews

Key Roles (D, A, I)

• Establish and maintain documentation systems (D)
• Decide on compliance-related actions (D)
• Advise on documentation update needs (A)
• Advise on document access needs (A)

Additional Accountabilities

• Site Representation & Communication: Serve as the site's backup representative for the CMS Community of Practice (CoP) and participate in Centers of Excellence (CoE) when requested, ensuring effective local communication and knowledge transfer
• Third-Party Storage Coordination: Act as support liaison with approved third-party vendors for off-site storage activities, ensuring compliance with records retention requirements
• Leadership & Project Support: Provide supervisory support on behalf of management as needed and serve as team member or lead for cross-functional improvement initiatives and project teams
• Training & User Support: Deliver advanced guidance to CMS users and conduct specialized training sessions on documentation management processes and best practices
• Access Management: Process CMS Care access requests for all user roles (excluding Consumer level) to ensure appropriate system permissions
• Priority Reporting & Monitoring: Issue weekly high-priority Document Change Request (DCR) reports to ensure timely implementation
• MOSAIC Governance Support: Support documentation governance activities in alignment with MOSAIC project requirements and objectives
• Fly (Paperless) Deployment Program Support: Coordinate local project timelines and deliverables across multiple stakeholders; serve as a point of contact for business users regarding Fly-related inquiries and support needs; build and maintain strong relationships with cross-functional teams and ensure clear, concise project communications to diverse audiences
• Document Lifecycle Management: Distribute periodic review reports to ensure maintaining compliance with global and regulatory requirements; initiate reconciliation processes for superseded or obsoleted paper logbooks

Qualifications

• Bachelor's degree preferred
• Minimum of 4 years of experience in document management, continuous improvement methodologies, and cross-functional process involvement
• Pharmaceutical industry experience preferred

Skills

• Demonstrated experience leveraging digital tools and AI-enabled platforms to streamline documentation workflows, automate routine tasks, and improve data accuracy and retrieval efficiency
• Working knowledge of content management systems (CMS) and digital lifecycle management platforms (e.g., Veeva Vault), with the ability to quickly adapt to new digital and AI-driven tools
• Familiarity with AI-assisted document processing capabilities (e.g., intelligent search, automated classification, optical character recognition/OCR, generative AI for content drafting or summarization)
• Comfort working within paperless and digital transformation initiatives (e.g., Fly deployment program, MOSAIC governance), including supporting change management for digitized processes
• Basic data literacy able to interpret dashboards, reports, and system-generated analytics to identify trends, prioritize document updates, and support data-driven decision-making
• Proficiency with document management software and tools, such as content management systems (CMS), Adobe Acrobat, Microsoft Office Suite (including AI-enhanced features), and Veeva Vault
• Digital fluency and a growth mindset toward emerging AI tools; eager to learn and apply new technologies that increase documentation efficiency and quality
• Ability to evaluate, pilot, and champion AI and automation solutions within documentation and records management processes
• Excellent verbal and written communication skills to effectively collaborate with multiple levels in the organization
• Strong decision-making abilities with an analytical approach to problem-solving
• Ability to manage simultaneous priorities and coordinate complex, multi-workstream programs
• Adaptability and flexibility to work in a fast-changing, innovation-driven environment shaped by digital and AI transformation
• English language proficiency required (verbal and written)