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MDR - Sr Medical Writer

Danvers, MA 01923

Posted: 02/14/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 600073 Is job remote?: Yes Country: United States

Job Description

Top 3 things the manager is looking for: 
  1. Regulatory writing
  2. Ability to collate, analyze and discuss data from multiple sources
  3. Detailed oriented

Top 3 Tasks or Responsibilities in scope for this role:
  1. 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)
  2. Collaborate with the cross-functional team and manage review process of clinical documents to ensure timely document delivery
  3. 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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