Technical Documentation Expert

Roles & Responsibilities
• Develop, review, and maintain technical and regulatory documentation including SOPs, system manuals, validation documents, regulatory submissions, and user guides
• Create compliant documentation aligned with FDA, HIPAA, GxP, and 21 CFR Part 11 requirements
• Collaborate with IT, QA, Regulatory Affairs, Clinical, and Business teams to gather inputs and translate requirements into clear, structured documents
• Manage document lifecycle activities including version control, change management, and archival
• Support system implementations, upgrades, and CSV activities by producing required documentation deliverables
• Ensure documentation meets internal quality standards and external regulatory expectations
• Support audits and inspections by providing accurate, complete, and inspection-ready documentation
• Maintain audit trails and ensure ongoing documentation compliance

Qualification
• Bachelor’s degree in Life Sciences, Pharmacy, Healthcare, Engineering, or a related discipline

Experience
• Minimum 2+ years of experience in the US healthcare domain, preferably in pharma or life sciences
• 4+ years of overall experience in technical writing or documentation roles

Skills
• Strong understanding of FDA regulations, GxP, HIPAA, and healthcare compliance frameworks
• Experience documenting clinical systems, quality systems, regulatory platforms, or healthcare IT applications
• Proficiency with documentation tools such as MS Word, Confluence, SharePoint, FrameMaker, or similar
• Excellent written and verbal communication skills with high attention to detail
• Ability to work effectively in cross-functional, regulated environments

Good to Have
• Exposure to Computer System Validation (CSV) documentation
• Experience supporting clinical trials, pharmacovigilance, or manufacturing systems
• Familiarity with ICH guidelines, CDISC standards, or electronic submission formats
• Certification in technical writing, regulatory affairs, or quality systems

About the Organization
The organization operates within the healthcare and life sciences space, supporting regulated systems and processes through robust documentation practices, with a strong focus on compliance, quality, and continuous improvement across global regulatory standards.