Medical Writer

Skills & Competences

• Scientific Literacy: strong foundation in life sciences, biomedical sciences, or medicine; able to understand and accurately interpret complex scientific and clinical data.
• Knowledge of regulatory guidelines: familiarity with applicable regulatory guidelines (e.g., EU MDR, IVDR, FDA, MDCG guidance documents) and Good Clinical Practices (GCP).
• Data Interpretation: Ability to interpret, synthesize and present clinical and scientific data clearly and concisely, without unnecessary complexity.
• Time Management & Prioritization: Capable of handling multiple projects and deadlines efficiently, with strong organizational skills.
• Attention to Detail: Strong focus on accuracy, consistency, grammar, and data integrity in all written materials while maintaining oversight of the bigger picture.
• Adaptability: Comfortable working in dynamic environments, managing shifting priorities, evolving project scopes and cross-functional collaborations.
• Self-Motivated & Independent Worker: Proactive and reliable, with the ability to work independently and contribute meaningfully to team efforts.

In This Role, You Will Have The Opportunity To

• Develop, write and edit regulatory documents and technical documentation for medical devices and IVDs, such as Clinical Evaluations Plans and Reports, Performance Evaluation Plans and Reports.
• Perform MDR or IVDR-compliant systematic literature reviews.
• Develop, write and edit documentation for clinical studies for medical devices and IVDs, such as protocols, informed consent forms, and study reports.
• Write scientific publications and communication documents related to medical devices and IVDs.
• Ensure all documents are compliant with relevant regulations, industry standards, client-specific requirements and internal procedures.
• Collaborate closely with cross-functional teams and clients to gather and interpret input for the documents and ensure alignment on regulatory strategy.
• Deliver within the agreed timelines and budget.
• Stay updated on regulatory changes and medical writing best practices.

Essential Requirements

• Master or advanced degree in a scientific, medical, or life sciences field.
• Previous experience in a medical writing role or clinical operations role in the medical device or IVD field and/or willingness to follow medical writing training.
• Proficiency in Microsoft Office Suite and reference management software.
• Excellent written and verbal communication skills in English.