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Senior Analyst, Medical Writing

Senior Analyst, Medical Writing

VirtualVocationsSaint Petersburg, Florida, United States
3 days ago
Job type
  • Full-time
Job description

A company is looking for a Senior Analyst, Medical Writing, Clinical & Regulatory Affairs.

Key Responsibilities

Plan, prepare, and finalize regulatory documents for global post-market surveillance, including clinical evaluation plans and reports

Conduct literature and clinical data reviews to support regulatory document preparation

Collaborate with cross-functional teams to ensure regulatory documents meet guidelines and company standards

Required Qualifications

Minimum of a Bachelor's degree (BS / BA); advanced degree preferred

At least 4 years of relevant scientific / med tech experience; clinical research experience preferred

At least 3 years of medical writing experience; cardiovascular disease experience preferred

Authoring experience with CERs, post-market surveillance plans, SSCPs, and PMCFs required

Strong knowledge of FDA and EU MDR regulations and post-market requirements

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Medical Writing • Saint Petersburg, Florida, United States

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