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.
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