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MDR - Sr Medical Writer

Danvers, MA 01923

Posted: 04/16/2024 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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About Danvers, MA

Ready to take the next step in your career? Explore our job opportunities in the vibrant area around Danvers, Massachusetts! Nestled in Essex County, this charming region offers a perfect blend of historic charm and modern amenities, making it an ideal place to live and work. With easy access to picturesque landmarks like Endicott Park and the Peabody Essex Museum, delectable seafood cuisine, and cultural hotspots like the North Shore Music Theatre and The Cabot, there's something for everyone here. Consider joining our team and immerse yourself in the unique culture and endless growth opportunities this enchanting area has to offer!

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