Sanofi

Documentation Specialist

Sanofi • $69K — $99K *
Swiftwater, PA 18370In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree preferred.
  • 4+ years in document management within the pharmaceutical industry.
  • Experience with digital tools and AI platforms for documentation workflows.
  • Proficiency in CMS and digital lifecycle management tools like Veeva Vault.
  • Basic data literacy for interpreting analytics and identifying trends.

Responsibilities

  • Manage the GxP documentation lifecycle from creation to obsolescence.
  • Collaborate across departments to align document content with business needs.
  • Ensure compliance of documentation with regulations and company standards.
  • Maintain a lean documentation package to eliminate redundancies.
  • Support audits by ensuring all documentation is up-to-date and accessible.

Benefits

  • Supportive, future-focused team environment.
  • Opportunities for career advancement, including international moves.
  • Comprehensive health and wellness benefits, including at least 14 weeks of parental leave.
  • Cutting-edge technology for transformative work in medicine.
  • Commitment to leveraging digital and AI innovations.
Full Job Description
Job Title: Documentation Specialist
  • Location: Swiftwater, PA

Main Responsibilities
  • Managing the GxP documentation lifecycle (creation, revision, and obsolescence
  • Collaborating with other departments to ensure document content addresses the business needs and processes
  • Ensuring, with the support of relevant experts that the documentation content is compliant with regulatory requirements and company standards
  • Ensuring the overall documentation package is kept lean (i.e., avoiding redundancies and duplication)
  • Ensuring accuracy, completeness, and compliance of the documentation with writing rules (incl. clarity and grammar)
  • Collecting needs for documentation changes, prioritizing and managing document updates
  • Ensuring the documentation is regularly updated to remain current and aligned with the needs and processes
  • Ensuring document distribution and access complies with the information classification level
  • Supporting internal and external audits and inspection by ensuring all required documents are up-to-date and retrievable
  • Supports record retention archiving procedures as a Business Archives Coordinator (BAC) on behalf of the Swiftwater site
  • Acts as liaison with approved third-party storage subcontractors
  • Provides guidance on archiving tools and processes
  • Supports 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 To locally support M&S Swiftwater site:
  • Site Representation & Communication: Serves as the site's backup representative for the CMS Community of Practice (CoP) and participates in Centers of Excellence (CoE) when requested, ensuring effective local communication and knowledge transfer
  • Third-Party Storage Coordination: Acts as support liaison with approved third-party vendors for off-site storage activities, ensuring compliance with records retention requirements
  • Leadership & Project Support
  • Provides supervisory support on behalf of management as needed and serves as team member or lead for cross-functional improvement initiatives and project teams
  • Training & User Support: Delivers advanced guidance to CMS users and conducts specialized training sessions on documentation management processes and best practices
  • Access Management: Processes CMS Care access requests for all user roles (excluding Consumer level) to ensure appropriate system permissions
  • Priority Reporting & Monitoring: Issues weekly high-priority Document Change Request (DCR) reports to ensure timely implementation
  • MOSAIC Governance Support: Supports documentation governance activities in alignment with MOSAIC project requirements and objectives
  • Fly (Paperless) Deployment Program Support: Coordinates local project timelines and deliverables across multiple stakeholders. Serves as a point of contact for business users regarding Fly-related inquiries and support needs; Builds and maintain strong relationships with cross-functional teams and ensures clear, concise project communications to diverse audiences
  • Document Lifecycle Management: Distributes periodic review reports to ensure maintaining compliance with global and regulatory requirements. Initiates reconciliation processes for superseded or obsoleted paper logbooks.


About You

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


Preferred Qualifications
  • 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 as they are introduced.
  • Familiarity with AI-assisted document processing capabilities (e.g., intelligent search, automated classification, optical character recognition/OCR, generative AI for content drafting or summarization) is highly valued.
  • 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.
  • Ability to manage simultaneous priorities and coordinate complex, multi-workstream programs.


Languages
  • English language proficiency required (verbal and written).

Why choose us?
  • Bring the miracles of science to life alongside a supportive, future-focused 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.
  • Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
  • Power industry-leading performance by leveraging digital, data, and AI-driven innovation - at speed and scale
  • Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

The salary range for this position is:
$69,000.00 - $99,666.66

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.

About Sanofi

Sanofi is a global pharmaceutical company that specializes in the research, development, and manufacturing of prescription drugs and vaccines. The company operates in over 170 countries and has a diverse portfolio of products that includes treatments for diabetes, cancer, cardiovascular disease, and rare diseases. Sanofi is committed to improving global health and has a strong focus on innovation and sustainability. The company has received numerous awards for its research and development efforts and is recognized as a leader in the pharmaceutical industry.
Learn more about Sanofi
Market Cap
$121.6 billion
Industry
Pharmaceuticals & Biotech
Net Income
$12.3 billion
Founded
1990
5 Year Trend
+2.5%
Revenue
$37.3 billion
NASDAQ
SNYNF
* Ladders Estimates

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