Technical Writer

2 days ago

Plainsboro, New Jersey, United States Xoriant Full time

Xoriant is an equal opportunity employer. No person shall be excluded from consideration for employment because of race, ethnicity, religion, caste, gender, gender identity, sexual orientation, marital status, national origin, age, disability or veteran status.

Job Title: Technical Writer/Documentation Specialist/Procedure Writer/Process Documentation Specialist/SOP Writer

Location: Plainsboro, NJ (Local candidates preferred)

Employment Type: Contract (1+ yrs Long Term)

Rate - Only Xoriant W2

Mode of Interview - Onsite/Teams.

Summary:

Seeking an experienced Technical Writer with strong pharmaceutical industry background to develop, revise, and manage GxP procedural documentation. This role supports process improvement, compliance, and training development within CMR Strategic Operations.

Key Responsibilities:

  • Lead cross-functional teams to create and maintain SOPs and process documentation in a GxP environment.
  • Manage multiple documentation and process enhancement projects.
  • Develop user-friendly training materials and job aids.
  • Ensure compliance with regulatory and corporate standards; support audit readiness.
  • Review and update global documentation per evolving regulations and best practices.

Qualifications:

  • Bachelor's degree (advanced degree or certification in process design/change management a plus).
  • 7+ years of experience in pharma business process design and documentation.
  • Proven expertise in GxP documentation; PV (pharmacovigilance) experience a strong plus.
  • Strong SOP writing and project management skills (PMP preferred).
  • Proficient in MS Word, Excel, Visio, Project, PowerPoint; SharePoint/Teams a plus.
  • Excellent communication, organizational, and multitasking skills.

Top Skills:

  • Pharma industry experience
  • GxP documentation expertise (not GMP)
  • SOP writing proficiency
  • Patient Safety / PV experience (huge plus)

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