Documentation Specialist

Sanofi; Waterford; Hybrid; EUR 45,000 - 65,000; Full time

Job summary

Sanofi Waterford is seeking a Documentation Specialist to join our Site Documentation Management team. You will manage the full GxP documentation lifecycle, ensuring accuracy, traceability, and compliance across CMS and archiving systems.

You will collaborate with cross-functional teams to reflect business needs, support audits, and maintain alignment with global procedures and regulatory requirements. Fluency in English is required.

Qualifications

• Experience in documentation management within a GxP environment.
• Familiarity with quality and documentation management systems is essential.
• Understanding regulatory standards and writing rules is required.

Responsibilities

• Manage the complete GxP documentation lifecycle, including creation, revision, and obsolescence.
• Collaborate across departments to ensure content reflects business needs and processes.
• Ensure documentation compliance with regulatory requirements and company standards.
• Maintain lean documentation by removing redundancies and duplication.
• Review documentation for accuracy, completeness, and grammar.
• Collect, prioritize, and manage documentation change requests to keep content current.
• Control document distribution and access according to classification levels.
• Support audits and inspections by ensuring documents are readily retrievable.
• Establish and maintain documentation systems and advise stakeholders on updates.

Skills

Documentation management

Quality assurance

Regulatory compliance

GxP experience

Tools

Documentation Management Systems

Job description

Documentation Specialist

Location: Waterford

About the job

Join our Site Documentation Management team, where we play a critical role in ensuring the integrity and compliance of all GxP documentation systems. We manage the complete lifecycle of critical documentation through our Content Management Systems (CMS) and Archiving platforms, ensuring alignment with Global procedures and regulatory requirements. Our team is at the heart of quality assurance, supporting both internal operations and external audits by maintaining accurate, accessible, and compliant documentation that enables Sanofi to deliver safe, effective treatments to patients worldwide.

Main Responsibilities

• Manage the complete GxP documentation lifecycle, including creation, revision, and obsolescence processes
• Collaborate across departments to ensure documentation content accurately reflects business needs and operational processes
• Ensure documentation compliance with regulatory requirements and company standards, working with relevant subject matter experts
• Maintain a lean documentation package by identifying and eliminating redundancies and duplication
• Review and ensure accuracy, completeness, and compliance of documentation with established writing rules, including clarity and grammar standards
• Collect, prioritize, and manage documentation change requests to keep content current and aligned with evolving processes
• Control document distribution and access in accordance with information classification levels
• Manage the issue, control, and reconciliation of logbooks to ensure compliance with site needs
• Maintain onsite archives and ensure alignment between onsite and offsite archiving processes with Global procedures
• Support internal and external audits and inspections by ensuring all required documents are readily retrievable.
• Establish and maintain documentation systems, making key decisions on compliance-related actions
• Advise stakeholders on documentation update needs and document access requirements

About You

Experience: Background in documentation management, quality assurance, or regulatory compliance within a GxP environment; familiarity with Quality and Documentation Management Systems is a must.

Soft skills

• Strong attention to detail and commitment to accuracy
• Excellent collaboration and communication abilities across diverse teams
• Ability to prioritize and manage multiple documentation projects simultaneously
• Problem-solving mindset with a focus on continuous improvement
• Proactive approach to identifying and addressing documentation gaps

Technical skills

• Knowledge of GxP documentation requirements and regulatory standards
• Understanding of documentation lifecycle management principles
• Proficiency with documentation management systems
• Strong writing and editing capabilities

Languages

Fluency in English is required.

Pursue Progress, Discover Extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! #LI-EU

Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

The salary range for this position is : Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.

We are an R&D driven, AI-powered biopharma company committed to improving people's lives and creating compelling growth.

Our team is guided by one purpose: we chase the miracles of science to improve people's lives. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world.

Discover more about us visiting www.sanofi.com or via our movie

We are Sanofi Start a career that makes a difference. Reinvention is in our DNA. It's what drove our evolution from a small French enterprise to one of the world's leading biopharma companies. Whether it's using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people's lives.