Technical Writer

PSC Biotech Corporation; Cork; On-site; EUR 50,000 - 70,000; Full time

Job summary

PSC Biotech Corporation in Cork seeks a dedicated Technical Writer for the Biologics Centre of Excellence. The role focuses on documentation management, training coordination, and producing compliant GMP documentation.

You will serve as SME for Veeva QualityDocuments and Compliance Wire, draft and review BPDs, SOPs, protocols and reports, and drive continuous improvements to the writing process across the site. This is a 12-month contract with potential extension.

Qualifications

• Experience in technical document writing within pharma/biotech.
• Experience with Veeva QDocuments and regulatory document workflows.
• Strong training coordination and materials development abilities.
• Ability to work independently with disciplined organization.

Responsibilities

• Lead the documentation management strategy and ensure regulatory readiness.
• Produce high-quality, compliant documentation applying data integrity and ALCOA.
• Serve as SME for Veeva QualityDocuments & Compliance Wire across teams.

Skills

Technical writing

Training coordination

Data integrity

ALCOA principles

Regulatory compliance

Education

Science or Engineering degree

Tools

Veeva QualityDocuments

Compliance Wire

Job description

• Industry Pharma/Biotech/Clinical Research
• City Cork
• State/Province Cork
• Country Ireland

Job Description

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient’s expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.

Summary

• The Biologics Centre of Excellence Technical Writersupports Biologics CoE operations through effective document management andtraining administration. This role requires strong technical writing expertisewith training coordination, thereby ensuring regulatory compliance, inspectionreadiness, and support personnel cross-training. The role requires demonstratedskills for initiative, self-motivation, outstanding organisational skills, anda proven ability to work independently.
  
• 12 Month of Contract with possibility of an extension
  

Requirements

Key Responsibilities

• Lead, develop, and drive the ongoing enhancement of thedocumentation management strategy
  
• Produce high-quality, accurate documentation by applyingdata integrity and ALCOA principles, adhering to compliance best practices, andensuring all materials are appropriate for their intended audience
  
• Serve as Subject Matter Expert (SME) for Veeva QualityDocuments & Compliance Wire, offering guidance and support to colleagues inthe use of these systems
  
• Draft, review, and approve BPDs, SOPs, technicalprotocols & reports, forms, work instructions, and other document types
  
• Collaborate closely with technical SMEs and teams to gaindeep business and product knowledge for accurate documentation requirements
  
• Demonstrate excellent verbal and written communicationskills to engage and motivate diverse audiences
  
• Propose and implement continuous improvements to thetechnical writing process, such as developing Advanced Templates
  
• Support Technical Writing activities across the site andcollaborate with various departmental SMEs
  
• Manage the transition of documentation into Veeva QualityDocuments and initiate Change Requests as necessary
  
• Support Global Training &/or Bus Ops with BcoEtraining development programs and materials, guides, and e-learning modules toaddress identified learning requirements
  

Education and Experience (required):

• Third level qualification in a Science or an Engineeringdiscipline, and/or extensive related proven experience in the required areas:technical document writing