MDR - Sr Medical Writer
Virtual Location Danvers, MA 01923 US
Job Description
- Regulatory writing
- Ability to collate, analyze and discuss data from multiple sources
- Detailed oriented
Top 3 Tasks or Responsibilities in scope for this role:
- Clinical evaluation deliverables related to MDR and other global regulations, such as: State of the Art (SOTA), Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance (SSCP), and Periodic Safety Update Reports (PSURs)
- Collaborate with the cross-functional team and manage review process of clinical documents to ensure timely document delivery
- Manage notified body feedback
Clinical Evaluation Medical Writing
- Review and summarize scientific literature
- Report instances of complaints/adverse events from literature to GCH
- Create responses for audit/submission queries
- Maintain database of peer-reviewed literature
- Appraise, analyze, summarize, and discuss clinical evidence from all the available sources
- Conduct comprehensive literature searches and performs a critical evaluation of clinical evidence
- Develop state of the art on product family for its intended purpose
- Create & maintain plans and reports for regulatory authorities
- Review/approve other documentation for device development
- Knowledge of regulatory agencies’ guidelines on clinical evaluation requirements.
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