(CW) Technical Writer

BioMarin Pharmaceutical Inc. · Ireland · 2 months ago

Employment: Contract
Category: Technical writing
Company size: 1000+

regulatory-compliance technical-writing veeva

A technical writer at BioMarin drafts and manages regulatory documents, SOPs, and training materials for biologics operations, ensuring compliance and supporting cross-team training.

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Worldwide Research and Development

From research and discovery to post-market clinical development, our R&D engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases.

Title: (CW) Technical Writer

Contract type: 12 months

Location: Cork, Ireland

Role 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.

Key Responsibilities

Technical Writing

• 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

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Ireland Safety Responsibility
Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

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