Medical Writer (Remote)

About the Role

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.

The role includes interaction with various internal departments and external vendors or key opinion leaders to ensure high-quality clinical documentation and submission readiness.

Responsibilities

• Conduct comprehensive literature reviews and analyze clinical data.
• Support clinical development strategies.
• 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.
• Contribute to SOP improvements.

Requirements

• Bachelor's degree in a scientific field.
• 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.
• Proficiency in literature search tools and Microsoft Office.
• Ability to work independently, prioritize tasks, and collaborate with internal teams and external stakeholders.

Benefits

The role offers comprehensive benefits.

Pay

$105,000–$115,000 per year.

Schedule

Remote or hybrid work options available.