Technical Writer/Procedure Document Specialist IV

Location: Plainsboro, NJ - Onsite

Duration: 12 Months Contract

Job Summary:

Seeking an experienced professional to support strategic operations, GxP compliance, and technical operations. The role focuses on developing, revising, and managing procedural documentation, improving business processes, and ensuring inspection readiness.

Key Responsibilities:

• Lead cross-functional teams to create and update SOPs and process documents.
• Develop user-friendly training materials and job aids.
• Ensure documentation meets global GxP standards and audit requirements.
• Manage multiple documentation projects and support continuous improvement.
• Create process maps and visuals using Visio or similar tools.

Qualifications:

• Bachelor’s degree required; advanced degree/certification in technical writing or change management preferred.
• 7 years’ experience in pharma process documentation, GxP compliance, and change management.
• Pharmacovigilance (PV) or Patient Safety experience is a strong plus.
• Strong skills in MS Office, Visio, SharePoint, and project management (PMP preferred).

Top Skills:

• GxP documentation
• SOP writing
• PV experience
• Project management
• Training material development
• Visio process mapping

We are committed to creating a diverse and inclusive environment and welcome applications from all qualified individuals. For immediate consideration please click APPLY.