CMC Writer

Ardena Careers

. Write and compile scientific and technical documents related to drug substance development for new chemical entities and biological products .

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

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in scientific and technical writing for drug substance development, with a strong focus on regulatory compliance and collaboration in a dynamic environment. Proficient in preparing critical documentation for global regulatory submissions and conducting assessments per ICH guidelines.

Highest-signal resume keywords

Scientific WritingDrug Substance DevelopmentRegulatory SubmissionsICH Guidelines ComplianceMS Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Scientific WritingDrug Substance DevelopmentRegulatory SubmissionsNitrosamine AssessmentMutagenicity AssessmentSynthesis Criticality AssessmentImpurity ManagementControl Strategy EstablishmentOrganic ChemistryTechnical Document Preparation

Soft Skills

Attention to DetailProblem-SolvingCommunication SkillsOrganizational SkillsEager to Learn

Tools & Technologies

MS OfficeWordExcel

Industry Keywords

Drug DevelopmentBiopharmaceuticalsICH M7EU Work EligibilityBelgium Work Eligibility

About the role

Key responsibilities & impact

Write and compile scientific and technical documents related to drug substance development for new chemical entities and biological products
Prepare synthesis criticality assessments, starting material justification reports, impurity management reports, and documents related to upscaling of synthesis processes
Prepare documents used as the basis for global regulatory submissions, including clinical trial applications and marketing applications
Establish the control strategy for drug substance manufacturing, including specifications
Conduct nitrosamine and mutagenicity assessments per ICH M7
Align documents to ensure compliance with the latest ICH guidelines
Manage and coordinate technical writing and reviewing activities
Collaborate with experienced colleagues and other Ardena teams to provide CMC advice throughout drug development and dossier submission

Requirements

What you’ll need

Master’s degree or Ph.D. in chemistry or biotechnology
Affinity with organic chemistry and drug substance development is a plus
Passion for scientific and technical writing for chemical and biopharmaceutical products
Strong interest in drug development and regulatory guidelines
Proficient in MS Office, primarily Word and Excel
Very good written and spoken communication skills
Fluent in written and spoken English
Strong scientific writing skills
Attention to detail and accuracy
Eager to learn and able to work independently when necessary
Problem-solving skills with a quality-conscious attitude
Well-organized with the ability to work in a dynamic environment
AI savviness is a must
Only candidates eligible to work in the EU will be considered
Candidates must be entitled to work in Belgium

Benefits

Comp & perks

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
Supportive learning environment for skill development and growth
Opportunity to contribute to the development of new drugs
Involvement in a rapidly growing international company
Dynamic working environment with friendly and collaborative colleagues
Open, straightforward, and caring company culture