Regulatory Biologics Technical Writer & Training Lead

BioMarin Pharmaceutical Inc.; Ireland; On-site; EUR 48,000 - 64,000; Full time

Job summary

BioMarin Pharmaceutical Inc. in Cork, Ireland is seeking a technically skilled Technical Writer to support Biologics CoE operations with document management and training administration.

This 12-month contract requires strong technical writing, regulatory compliance, and collaboration with SMEs to produce SOPs, protocols, reports, and training materials, ensuring ALCOA data integrity and inspection readiness.

Qualifications

• Requires a third-level qualification in a Science or Engineering discipline.
• Demonstrated technical writing experience in regulated environments.
• Experience coordinating training activities and programs.

Responsibilities

• Lead and manage documentation strategies and ensure data integrity per ALCOA.
• Draft, review, and approve regulatory documents (BPDs, SOPs, technical protocols, reports).
• Collaborate with SMEs to capture in-depth product knowledge for accurate documentation.
• Support training development programs and e-learning materials.
• Assist in transitioning documents to Veeva Quality Documents and manage change requests.

Skills

Technical writing

Training coordination

Regulatory compliance

ALCOA data integrity

Education

Science or Engineering degree

Tools

Veeva Quality Documents

Compliance Wire

Job description

BioMarin Pharmaceutical Inc. in Cork, Ireland is seeking a technically skilled Technical Writer to support Biologics CoE operations with document management and training administration.

This 12-month contract requires strong technical writing, regulatory compliance, and collaboration with SMEs to produce SOPs, protocols, reports, and training materials, ensuring ALCOA data integrity and inspection readiness.