Technical Writer

About PSC Biotech

• Who are we?
• PSC Biotech is a leading Biotech Consultancy firm founded
• in 1996, headquartered in Pomona, California, USA, with Global operations in
• Ireland, India, Singapore, Australia and the US, serving 350 clients in more
• than 23 countries worldwide. We provide cloud-based software solutions for
• Quality Management and Regulatory Inspections, pharmaceuticals contract
• manufacturing professionals, and metrology services to our clients.
• ‘Take your Career to a new Level’
• PSC Biotech disrupts the conventional consultancy model
• by aligning our EVP as one of the unique selling point which includes the
• opportunity to work with the most talented cohort of like-minded professionals
• operating in the Pharma/ Biotech Industry. We offer a permanent contract of
• employment giving exposure of working in Top Pharmaceutical client sites in a
• diverse-cultural work setting.

Employee Value Proposition

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

Summary

• The Biologics Centre of Excellence Technical Writer
• supports Biologics CoE operations through effective document management and
• training administration. This role requires strong technical writing expertise
• with training coordination, thereby ensuring regulatory compliance, inspection
• readiness, and support personnel cross-training. The role requires demonstrated
• skills for initiative, self-motivation, outstanding organisational skills, and
• a 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 the
• documentation management strategy
• Produce high-quality, accurate documentation by applying
• data integrity and ALCOA principles, adhering to compliance best practices, and
• ensuring all materials are appropriate for their intended audience
• Serve as Subject Matter Expert (SME) for Veeva Quality
• Documents & Compliance Wire, offering guidance and support to colleagues in
• the use of these systems
• Draft, review, and approve BPDs, SOPs, technical
• protocols & reports, forms, work instructions, and other document types
• Collaborate closely with technical SMEs and teams to gain
• deep business and product knowledge for accurate documentation requirements
• Demonstrate excellent verbal and written communication
• skills to engage and motivate diverse audiences
• Propose and implement continuous improvements to the
• technical writing process, such as developing Advanced Templates
• Support Technical Writing activities across the site and
• collaborate with various departmental SMEs
• Manage the transition of documentation into Veeva Quality
• Documents and initiate Change Requests as necessary
• Support Global Training &/or Bus Ops with BcoE
• training development programs and materials, guides, and e-learning modules to
• address identified learning requirements

Education and Experience (required)

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