Medical Writer (Remote

Role Overview:

This position involves leading and developing clinical evaluation and investigation documents, including Clinical Evaluation Reports (CER), literature reviews, and safety summaries in compliance with EU MDR and MEDDEV guidelines.

Conduct comprehensive literature reviews, analyze clinical data, support clinical development strategies, and prepare clinical study documentation such as protocols, Investigator's Brochures, and reports. Serve as a subject matter expert on clinical aspects of technical documentation, assist with manuscript and abstract development for publication and conferences, and contribute to SOP improvements.

Bachelor's degree in a scientific field, with at least 3 years of medical writing experience, preferably within the Medical Device industry. Strong knowledge of regulations (EU MDR, ISO standards, GCP), excellent project management, analytical, and communication skills are essential. Proficiency in literature search tools and Microsoft Office is required. Ability to work independently, prioritize tasks, and collaborate with internal teams and external stakeholders is vital.

The role offers remote or hybrid work options, with a salary range of $105,000–$115,000, and includes comprehensive benefits. The position involves interaction with various internal departments and external vendors or key opinion leaders to ensure high-quality clinical documentation and submission readiness.