Technical Writer – Synthetics & Biotherapeutics (Hybrid)

Ardena Careers; Oost-Vlaanderen; Ibrido; EUR 70.000 - 100.000; Tempo pieno

Vantaggi offerti da questo lavoro

Meal vouchers

Group/hospitalization insurance

Flexible working hours

Partial telework

Descrizione del lavoro

Ardena Gent, Belgium, is seeking a Technical Writer focused on Synthetics and/or Biotherapeutics to support development by preparing high-quality technical documentation. You will collaborate with experienced professionals in a fast-evolving pharmaceutical field and contribute to regulatory submissions.

Ideal candidates hold a PhD in a life sciences field or equivalent experience, with strong writing skills, English fluency, and meticulous attention to detail.

Competenze

• Ph.D. in Pharmaceutical Sciences, Biotechnology, Bioengineering, or a related life sciences field or equivalent professional experience.
• Strong interest in drug development, regulatory science, and technical writing for chemical/biological products.

Mansioni

• Support the development, coordination and authoring of scientific and technical documentation for synthetic and biotherapeutics, including ICH M7 Nitrosamine risk assessments and related reports.
• Establish and maintain project workplans and coordinate cross-functional Subject Matter Experts.
• Track actions, dependencies and timelines; drive documentation through review and approval.
• Ensure documents comply with current ICH and regulatory guidelines.
• Ensure high-quality documentation and discuss potential issues with the customer.

Conoscenze

Team player

Communication

English fluency

Documentation

Attention to detail

Organized

Independence

Analytical mindset

AI savviness

Formazione

Ph.D. in Pharmaceutical Sciences

Strumenti

MS Office (Word, Excel)

Descrizione del lavoro

Ardena Gent, Belgium, is seeking a Technical Writer focused on Synthetics and/or Biotherapeutics to support development by preparing high-quality technical documentation. You will collaborate with experienced professionals in a fast-evolving pharmaceutical field and contribute to regulatory submissions.

Ideal candidates hold a PhD in a life sciences field or equivalent experience, with strong writing skills, English fluency, and meticulous attention to detail.