Documentation Specialist
Sanofi
August 24, 2026
On-site
Swiftwater, PA
$69,000 - $99,666.66 USD yearly
Operations
Main Responsibilities
- Manage the GxP documentation lifecycle (creation, revision, obsolescence).
- Collaborate with other departments to ensure documentation addresses business needs and processes.
- Ensure documentation content is compliant with regulatory requirements and company standards.
- Keep documentation packages lean (avoid redundancies/duplication).
- Ensure documentation accuracy, completeness, and compliance with writing rules (clarity/grammar).
- Collect documentation change needs; prioritize and manage updates.
- Ensure documents remain current and aligned with evolving needs/processes.
- Ensure document distribution and access comply with information classification level.
- Support internal/external audits and inspections by ensuring documents are up-to-date and retrievable.
- Support record retention archiving procedures as a Business Archives Coordinator (BAC) for the Swiftwater site.
- Liaison with approved third-party storage subcontractors; provide guidance on archiving tools/processes.
- Support annual archival eligibility reviews.
- Serve as backup CMS Community of Practice (CoP) representative; participate in Centers of Excellence (CoE) when requested.
- Support CMS user training, access management (CMS Care requests), and weekly high-priority Document Change Request (DCR) reporting.
Basic Qualifications
- Bachelor’s degree preferred.
- 4+ years of document management, continuous improvement, and cross-functional process involvement (pharma preferred).
Preferred Qualifications / Skills
- Experience with digital tools and AI-enabled platforms to streamline workflows and improve accuracy/retrieval.
- Working knowledge of CMS and digital lifecycle management platforms (e.g., Veeva Vault).
- Familiarity with AI-assisted document processing (intelligent search, automated classification, OCR, generative AI).
- Comfort with paperless/digital transformation (Fly, MOSAIC); support change management.
- Data literacy; interpret dashboards/reports.
- Proficiency with CMS, Adobe Acrobat, Microsoft Office, Veeva Vault.
- Strong communication, analytical problem-solving, decision-making; manage multiple priorities.
- Ability to evaluate/pilot/champion AI and automation solutions.
Languages
- English required (verbal and written).
- Manage the GxP documentation lifecycle (creation, revision, obsolescence).
- Collaborate with other departments to ensure documentation addresses business needs and processes.
- Ensure documentation content is compliant with regulatory requirements and company standards.
- Keep documentation packages lean (avoid redundancies/duplication).
- Ensure documentation accuracy, completeness, and compliance with writing rules (clarity/grammar).
- Collect documentation change needs; prioritize and manage updates.
- Ensure documents remain current and aligned with evolving needs/processes.
- Ensure document distribution and access comply with information classification level.
- Support internal/external audits and inspections by ensuring documents are up-to-date and retrievable.
- Support record retention archiving procedures as a Business Archives Coordinator (BAC) for the Swiftwater site.
- Liaison with approved third-party storage subcontractors; provide guidance on archiving tools/processes.
- Support annual archival eligibility reviews.
- Serve as backup CMS Community of Practice (CoP) representative; participate in Centers of Excellence (CoE) when requested.
- Support CMS user training, access management (CMS Care requests), and weekly high-priority Document Change Request (DCR) reporting.
Basic Qualifications
- Bachelor’s degree preferred.
- 4+ years of document management, continuous improvement, and cross-functional process involvement (pharma preferred).
Preferred Qualifications / Skills
- Experience with digital tools and AI-enabled platforms to streamline workflows and improve accuracy/retrieval.
- Working knowledge of CMS and digital lifecycle management platforms (e.g., Veeva Vault).
- Familiarity with AI-assisted document processing (intelligent search, automated classification, OCR, generative AI).
- Comfort with paperless/digital transformation (Fly, MOSAIC); support change management.
- Data literacy; interpret dashboards/reports.
- Proficiency with CMS, Adobe Acrobat, Microsoft Office, Veeva Vault.
- Strong communication, analytical problem-solving, decision-making; manage multiple priorities.
- Ability to evaluate/pilot/champion AI and automation solutions.
Languages
- English required (verbal and written).