We are currently searching for a skilled professional to join a well-known client’s team as a Senior Medical Writer/Clinical Evidence Specialist in Mounds View, Minnesota or Remotely. The Senior Clinical Evidence Specialist oversees the clinical evaluation process for cardiac medical devices in compliance with applicable clinical and regulatory standards and in alignment with business needs. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES
• Provide scientific and/or medical expertise, analytical thought processes and a robust, systematic clinical evaluation approach in order to continuously collect, analyze and assess clinical data on Cardiac Rhythm (CRM) products throughout their lifecycle.
• Collaborate with cross-functional teams on establishing clinical safety and performance objectives for medical devices and defining the associated appraisal and analysis plans for various types of data sets across the lifecycle of the medical device.
• Plan and develop clinical evaluation plans, reports, post market clinical follow-up plans and reports, summary of safety and clinical performance, and other related deliverables.
• Manage project schedules for each document to ensure timely execution.
• May interact with regulatory agencies.

EXPERIENCE
Minimum of 4 years of clinical/medical/scientific writing experience, or advanced degree with a minimum of 2 years of clinical/medical/scientific writing experience

EDUCATION
Minimum of Bachelor’s Degree

To be a best-fit your strengths must include:
• Strong understanding of regulatory requirements & experience in writing regulatory reports including Clinical Evaluation Report (CER), Clinical Evaluation Plan (CEP), Post Market Clinical Follow-up (PMCF) Plan, PMCF- Report
• Experience in clinical evidence planning and/or development (e.g. creating surveys, identifying data needed to substantiate claims, developing literature search protocols, defining endpoints, etc.)
• Experience in a clinical or industry setting with knowledge of cardiovascular disease device therapies

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