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Senior Medical Writer at CooperCompanies

Trumbull, Connecticut, United States -

Full Time

Start Date

Immediate

Expiry Date

06 Aug, 26

Salary

0.0

Posted On

08 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

EU MDR, FDA Regulations, ISO Standards, Medical Writing, Clinical Data Interpretation, Document Management Systems, Microsoft Office Suite, Analytical Thinking, Clinical Trial Reporting, PMCF Documentation, CER Writing, Cross-functional Collaboration

Industry

Medical Equipment Manufacturing

Description

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

Develop and manage high-quality clinical and regulatory documents to ensure compliance with EU MDR and FDA standards. Plan and report clinical data collection for Post-Market Clinical Follow-up and clinical trials.