Job Description:

We are seeking a skilled Technical Writer with a strong background in IT systems and Computer System Validation (CSV) for electronic systems to join our pharmaceutical client in RTP. In this role, you will develop, organize, and manage critical documentation that supports our IT systems, ensuring compliance with regulatory standards and facilitating smooth communication among teams.

Key Responsibilities:

• Develop and maintain comprehensive documentation, including user manuals, standard operating procedures (SOPs), validation protocols, and system requirement specifications.
• Collaborate closely with IT teams, quality assurance, and project managers to gather detailed technical information and convert it into easily understandable documentation.
• Ensure all documentation adheres to applicable regulatory and compliance standards, including GxP and 21 CFR Part 11 requirements.
• Participate in the development and review of Computer System Validation (CSV) documentation, such as validation plans, test scripts, and traceability matrices.
• Conduct regular document reviews and updates to maintain accuracy and relevance, especially as systems evolve or regulations change.
• Assist in the creation of training materials and user guides to support system implementation and user adoption.
• Manage documentation repositories and maintain version control for all written materials.

Qualifications:

• Bachelor’s degree in Information Technology, Computer Science, Life Sciences, Technical Writing, or a related field.
• Proven experience as a Technical Writer in a pharmaceutical or life sciences environment, with a focus on IT systems.
• Hands-on experience with Computer System Validation (CSV) processes for electronic systems.
• Familiarity with regulatory requirements for documentation and system validation, including GxP and 21 CFR Part 11.
• Strong technical writing and communication skills, with the ability to present complex information clearly and concisely.
• Proficiency in Microsoft Office Suite and experience with documentation management systems.
• Detail-oriented with excellent organizational skills and the ability to manage multiple projects simultaneously.

*No C2C Sponsorship available*