Job Description

Job Title: Technical Writer – Pharma IT Compliance

Location: Remote, Canada (Must Support EST Time Zone)

Position Summary

We are seeking a Technical Writer – Pharma IT Compliance to join our client’s global pharmaceutical IT team. The ideal candidate will develop, maintain, and enhance IT process documentation in compliance with GxP and regulatory requirements . This position plays a critical role in ensuring infrastructure qualification, documentation quality, and alignment with global IT compliance standards.

The role requires close collaboration with IT Compliance, Quality Assurance, and Global Shared Services teams to ensure all deliverables meet company and industry expectations.

Key Responsibilities

• Develop, author, and maintain IT policies, SOPs, plans, specifications, protocols, and reports.
• Lead and facilitate IT process improvement initiatives related to documentation and compliance.
• Act as the Infrastructure Qualification Lead for PSG sites to ensure global/local alignment on qualification deliverables.
• Guide project teams on GxP processes, qualification strategies, and compliance documentation.
• Manage and advise on change control processes in accordance with IT compliance standards.
• Collaborate with Global IT Shared Services to review and prepare GxP documentation for QA approval.
• Support the creation and review of IT-related agreements and compliance documentation.
• Participate in audit and inspection preparation, providing IT compliance support as needed.
• Support qualification/validation of mobile devices, scanners, and computers used in GxP environments.

Required Skills & Qualifications

• 5+ years of experience as a Technical Writer or in IT compliance documentation within the pharmaceutical or life sciences domain.
• Strong knowledge of GxP regulations, IT validation, and documentation management .
• Proven ability to author and manage controlled documentation (SOPs, protocols, and reports).
• Experience with infrastructure qualification and change control processes .
• Excellent written and verbal communication skills with exceptional attention to detail.
• Familiarity with audit support , regulatory inspections, and quality systems.
• Proficient with tools such as SharePoint, ServiceNow, and Power BI .
• Experience in manufacturing or regulated environments preferred.

Education

• Bachelor’s degree in Information Technology, Computer Science, Engineering, Life Sciences, or a related field.
• Master’s degree preferred but not required.

Preferred Experience

• Prior experience in pharmaceutical IT compliance and infrastructure qualification .
• Understanding of IT lifecycle documentation within regulated manufacturing systems.
• Ability to collaborate effectively with global and cross-functional teams .

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