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Medical Writer Senior Specialist

CooperCompanies
Posted a month ago, valid for 17 days
Location

Trumbull, CT 06611, US

Salary

Competitive

Contract type

Full Time

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Sonic Summary

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  • The Senior Medical Writer is responsible for creating and managing high-quality clinical and regulatory documents to support compliance with global standards such as EU MDR and FDA regulations.
  • Key responsibilities include planning, implementing, and reporting on clinical data collection for Post-Market Clinical Follow-up (PMCF) and clinical trials.
  • This position requires collaboration across various functions to maintain clinical documentation within the Quality Management System.
  • Candidates should have a minimum of 5 years of relevant experience in medical writing or a related field.
  • The salary for this role ranges from $80,000 to $120,000 per year, depending on experience and qualifications.

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.




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