Technical Writer – MSAT

Ardena Careers

. Support the development, coordination and, where appropriate, authoring and compiling of scientific and technical documentation related to the development of synthetic and biotherapeutics .

Posted 10/14/2026full-timeGhent • BelgiumMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in scientific and technical documentation for synthetic and biotherapeutics, with a strong focus on regulatory compliance and high-quality deliverables. Proficient in analytical problem-solving and project coordination within cross-functional teams.

Highest-signal resume keywords

Ph.D. In Pharmaceutical SciencesTechnical WritingRegulatory SubmissionsICH Guidelines ComplianceMS Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Scientific DocumentationNitrosamine Risk AssessmentsCriticality AnalysesProcess Development ReportsInvestigation ReportsProject WorkplansDocumentation ReviewQuality FocusAnalytical MindsetProblem-Solving Skills

Soft Skills

Team PlayerExcellent Communication SkillsHighly OrganizedProactiveEager to Learn

Industry Keywords

Drug DevelopmentRegulatory ScienceBiotechnologyBioengineeringLife Sciences

About the role

Key responsibilities & impact

Support the development, coordination and, where appropriate, authoring and compiling of scientific and technical documentation related to the development of synthetic and biotherapeutics
Prepare ICH M7 Nitrosamine Risk Assessments
Prepare Criticality Analyses
Prepare Process Development Reports
Prepare Investigation Reports
Prepare other supporting documents for global regulatory submissions
Establish and maintain project workplans
Coordinate cross-functional Subject Matter Experts
Track actions, dependencies and timelines and drive documentation through review and approval
Ensure documents comply with current ICH and other applicable regulatory guidelines
Ensure high-quality documentation and discuss potential issues with the customer

Requirements

What you’ll need

Ph.D. in Pharmaceutical Sciences, Biotechnology, Bioengineering, or a related life sciences field, or equivalent relevant professional experience
Strong interest in drug development, regulatory science, and technical/scientific writing for chemical and biological products
Team player
Excellent written and verbal communication skills
Fluency in English (both written and spoken)
Proficiency in MS Office, particularly Word and Excel
Strong technical writing and documentation skills with keen attention to detail
Highly organized, with the ability to prioritize and adapt in a dynamic environment
Independent, proactive, and eager to learn
Analytical mindset with problem-solving skills and a strong quality focus
AI savviness is a must
Only candidates eligible to work in the EU will be considered

Benefits

Comp & perks

Opportunity to contribute to the development of new drugs
A supportive learning environment for skill development and growth
Involvement in a rapidly growing international company with an intriguing services, product, and customer portfolio
Dynamic working environment with friendly and collaborative colleagues
Open, straightforward, and caring company culture
Attractive remuneration package with extra-legal benefits such as meal vouchers and group/hospitalization insurance
Flexible working hours
Possibility for partial telework
Generous annual leave entitlement of 32 days