technical writer

Join our client as a Join UCB as a CMC Technical Writer & Data Checker

Location: Braine-l’Alleud, Walloon Brabant, Belgium

Department: Knowledge Management & Analytical Program – CMC Documentation

Contract: project contract as a Freelancer or consultant

Profiles: 1-3 years of experience

Key responsibilities:

• Write, update, and perform data checks on CMC documents for regulatory submissions (major and minor variations, extensions, etc.).
• Coordinate and plan the document writing and review process with internal stakeholders and experts.
• Perform data verification and resolve inconsistencies to ensure data quality and compliance.
• Collaborate cross-functionally with departments involved in the CMC documentation process.
• Identify opportunities to improve writing and data verification processes and propose actionable solutions.
• Ensure adherence to regulatory and internal quality standards.

Your profile:

• University degree in Life Sciences or equivalent by experience.
• Basic understanding of CMC-related disciplines from early development to commercialization.
• Familiarity with GMP, Regulatory Affairs, and quality standards.
• Experience in drafting CMC technical documentation for (bio)pharmaceutical products is a plus.
• Knowledge of ICH, EMA, and FDA guidelines is considered an asset.
• Strong written and verbal communication skills in both French and English.
• Attention to detail, analytical thinking, and ability to synthesize complex information.
• A team player with a proactive mindset and willingness to learn.
• Comfortable using IT tools and digital platforms.

Your role: ensuring quality and consistency in CMC documentation

As a CMC Technical Writer & Data Checker, you will be responsible for the creation, update, and review of technical CMC documentation for one or more (bio)pharmaceutical products. You will work closely with subject matter experts to ensure the accuracy, clarity, and regulatory compliance of the documentation submitted to health authorities.