Senior Medical Writer

Job Summary

Working remotely in a full-time capacity, the Senior Medical Writer will develop and maintain key clinical evaluation documents, including Clinical Evaluation Reports and Periodic Safety Update Reports, while collaborating with cross-functional teams to support regulatory and clinical documentation requirements.

Key responsibilities

• Conduct comprehensive literature searches and critically evaluate clinical evidence
• Develop responses for audit and submission queries while ensuring high-quality project delivery
• Collaborate with cross-functional teams to review and approve documentation related to device development

Required qualifications

• Bachelor's degree required
• Minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience
• Experience with medical and/or scientific writing in the medical device industry
• Knowledge of regulatory agencies' guidelines on clinical evaluation requirements
• Ability to engage with peers and foster a collaborative learning environment