Technical Writer with focus on Synthetics and/or Biotherapeutics

Ardena; Oost-Vlaanderen; Ibrido; EUR 70.000 - 105.000; Tempo pieno

Vantaggi offerti da questo lavoro

Meal vouchers

Group insurance

Flexible working hours

Partial telework

Annual leave 32 days

Descrizione del lavoro

Ardena is seeking a Technical Writer focused on synthetics and biotherapeutics to support CMC documentation. You will prepare, organize, and harmonize technical files for regulatory submissions, collaborating with cross-functional teams to ensure accuracy and timeliness.

The role offers exposure to early development through regulatory support in a fast-evolving pharmaceutical environment, with flexible hours and partial telework available.

Competenze

• PhD in Pharmaceutical Sciences or related life sciences field, or equivalent professional experience.
• Strong interest in drug development, regulatory science, and scientific writing for chemical/biological products.

Mansioni

• Prepare high-quality technical documentation for synthetic and biotherapeutics development.
• Coordinate cross-functional Subject Matter Experts and manage timelines.
• Author and compile documents for global regulatory submissions.
• Ensure documents meet current ICH and regulatory guidelines.
• Discuss issues with customers and maintain high-quality deliverables.

Conoscenze

Team player

Technical writing

English fluency

MS Office

Attention to detail

Formazione

PhD in Pharmaceutical Sciences

Strumenti

Microsoft Word

Microsoft Excel

Descrizione del lavoro

About Us

At Ardena, we’re helping shape the future of medicine. Our teams work on the development of innovative and complex therapies that can improve the lives of patients around the world. As a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO), Ardena partners with pharmaceutical and biotech companies to turn scientific ideas into real treatments. From early development to manufacturing and regulatory support, we help bring new medicines to market faster and with the highest quality standards. With more than 750 colleagues across Europe and the United States, Ardena offers expertise in drug substance and drug product development, manufacturing, bioanalytical services, clinical logistics, fill & finish, and CMC regulatory support. But what truly makes Ardena special is our people. We are a science-driven and people-focused company where collaboration, innovation, and curiosity are encouraged. We offer an international environment where you can learn, take initiative, and grow your career across teams, functions, and locations. Our way of working is guided by our CARE values: Communicative, Accountable, Reliable, and Excellent. These values shape how we collaborate, solve challenges, and support each other every day. At Ardena, you’re not just building your career — you’re helping build the future of medicine. For the Ardena branch based in Gent, Belgium, our CMC Regulatory Team is looking for a

Technical Writer With Focus On Synthetics And/or Biotherapeutics

The CMC Regulatory team is dedicated to delivering customized and timely regulatory drug development services to our valued customers. Our support spans all aspects of Chemistry, Manufacturing & Control (CMC) writing activities across various stages of the drug development process. We collaborate closely with other Ardena teams, providing CMC advice throughout drug development and dossier submission.

Position Overview

As a Technical Writer with focus on Synthetics and/or Biotherapeutics, you will play a key role in supporting process development by preparing high-quality technical documentation. This position offers an excellent opportunity to collaborate with experienced professionals and gain hands-on exposure to the dynamic and fast-evolving pharmaceutical field.

Key Responsibilities

• Support the development, coordination and, where appropriate, authoring and compiling scientific and technical documentation related to the development of synthetic and biotherapeutics, including:
  • ICH M7 Nitrosamine Risk Assessments
  • Criticality Analyses
  • Process Development Reports
  • Investigation reports
  • 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

Your Profile

Education & Interests

• 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

Skills & Competencies

• 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!

What We Offer

• 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 and the possibility for partial telework.
• Generous annual leave entitlement of 32 days.

Email: [e-mail], Tel: [phone].

Only candidates eligible to work in the EU will be considered for the position. Unfortunately, given the high volume of applications we receive for our vacancies, these professionals (not entitled to work in Belgium) will not be given a status update.