Medical Writer Senior Specialist

CooperCompaniesTrumbull, CT
1d

About The Position

The Senior Medical Writer is responsible for developing, writing, and managing high-quality clinical and regulatory documents that support compliance and product lifecycle needs for global standards such as EU MDR and FDA regulations. This includes planning, implementing, and reporting clinical data collection for Post-Market Clinical Follow-up (PMCF) and clinical trials, ensuring adherence to global regulatory standards. The role collaborates cross-functionally to maintain clinical documentation within the Quality Management System and stays current with scientific literature and regulatory requirements.

Responsibilities

  • Developing, writing, and managing high-quality clinical and regulatory documents
  • Planning, implementing, and reporting clinical data collection for Post-Market Clinical Follow-up (PMCF) and clinical trials
  • Ensuring adherence to global regulatory standards
  • Collaborating cross-functionally to maintain clinical documentation within the Quality Management System
  • Staying current with scientific literature and regulatory requirements
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