Documentation Specialist
About this opportunity
Documentation Specialist
Location: Waterford
---
About the job
Our Team
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.
Job details
How this role compares
Computed from every other active Facilities & Administration role in our database, not just this employer's listings.
We currently track 103 comparable Facilities & Administration roles across 36 biopharma companies.
Salary context
21 of 103 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 103 comparable roles
+ 17 more countries
Seniority mix
23 of 103 peers have a known seniority level
Therapeutic area mix
2 of 103 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.