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Senior Medical Writer

CooperCompanies
Posted 16 days ago, valid for 8 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 developing and managing high-quality clinical and regulatory documents to ensure compliance with global standards such as EU MDR and FDA regulations.
  • This role involves planning, implementing, and reporting clinical data collection for Post-Market Clinical Follow-up (PMCF) and clinical trials.
  • The Senior Medical Writer must ensure adherence to global regulatory standards throughout the documentation process.
  • Collaboration across functions is essential to maintain clinical documentation within the Quality Management System.
  • Candidates should have at least 5 years of experience and a salary range of $90,000 to $120,000 is offered for this 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.




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