Technical Writer - Shabally, Cork

RECRUITERS; Cork; On-site; EUR 50,000 - 70,000; Full time

Job summary

RECRUITERS seeks an experienced Technical Writer to support laboratory operations through high-quality documentation, document management and training coordination with a focus on regulatory compliance and data integrity.

You will lead documentation strategy, draft SOPs and reports, ensure ALCOA data integrity, and act as SME for Veeva Quality Documents and ComplianceWire, collaborating with technical teams to translate requirements into precise documentation.

Qualifications

• Third-level qualification in a Science or Engineering discipline or extensive relevant experience in technical document writing.
• Proven experience in technical writing and controlled documentation, ideally in pharmaceutical, biotechnology, laboratory or regulated environment.
• Strong understanding of GxP, regulatory compliance, data integrity and ALCOA principles.
• Experience with document management or quality systems, ideally Veeva Quality Documents and/or ComplianceWire.

Responsibilities

• Lead and enhance the site’s documentation management strategy and technical writing processes.
• Develop, draft, review and approve SOPs, reports, forms and work instructions.
• Ensure documentation meets data integrity and regulatory compliance requirements, while being audience-appropriate.
• Act as SME for Veeva Quality Documents and ComplianceWire, guiding colleagues.
• Collaborate with SMEs and cross-functional teams to translate requirements into accurate documentation.
• Manage transitions of documentation into Veeva and initiate Change Requests when needed.
• Identify and implement improvements to writing processes and templates.
• Support training development by creating training materials and e-learning content in collaboration with Global Training.

Skills

Technical writing

Documentation control

GxP compliance

Veeva systems

Education

Science or Engineering degree

Tools

Veeva Quality Documents

ComplianceWire

Job description

A leading biopharmaceutical organisation is seeking an experienced Technical Writer. The role will support laboratory operations through high-quality technical documentation, document management and training coordination, with a strong focus on regulatory compliance, data integrity and inspection readiness.

Key Responsibilities

• Lead and continuously enhance the site’s documentation management strategy and technical writing processes.
• Develop, draft, review and approve a range of controlled documents, including SOPs, BPDs, technical protocols, reports, forms and work instructions.
• Ensure documentation meets data integrity, ALCOA principles and regulatory compliance requirements, while remaining appropriate for its intended audience.
• Act as a Subject Matter Expert (SME) for Veeva Quality Documents and ComplianceWire, providing guidance and support to colleagues.
• Work closely with technical SMEs and cross-functional teams to understand business and product requirements and translate them into accurate, effective documentation.
• Manage the transition of documentation into Veeva Quality Documents and initiate Change Requests where required.
• Identify and implement continuous improvements to technical writing processes, including the development of advanced templates and improved documentation practices.
• Support training development programmes by creating training materials, guides and e-learning content, while collaborating with Global Training and Business Operations teams.

Requirements

• Third-level qualification in a Science or Engineering discipline, or extensive relevant experience in technical document writing.
• Proven experience in technical writing and controlled documentation, ideally within a pharmaceutical, biotechnology, laboratory or regulated environment.
• Strong understanding of GxP, regulatory compliance, data integrity and ALCOA principles.
• Experience working with document management or quality systems, ideally Veeva Quality Documents and/or ComplianceWire.
• Excellent written and verbal communication skills, with the ability to work effectively with technical SMEs and diverse stakeholders.
• Highly organised, self-motivated and able to work independently while managing multiple priorities in a regulated environment.