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Regulatory Sciences and Medical Writing

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Sr Medical Writer (Sr. Clin Evidence Specialist)

Saint Paul, MN 55112

Posted: 04/16/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 603214 Is job remote?: Yes Country: United States

Job Description

Max pay 50-65/h depending on experience

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 company business needs. This specialist provides 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. The specialist collaborates 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. The specialist plans and develops clinical evaluation plans, reports, post market clinical follow-up plans and reports, summary of safety and clinical performance, and other related deliverables. This individual also manages project schedules for each document to ensure timely execution. This individual may interact with regulatory agencies.

HM's Top 3: 
  1. 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
  2. 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.)
  3. Experience in a clinical or industry setting with  knowledge of cardiovascular disease device therapies 

Education Required: Bachelor’s degree

Years’ Experience Required: 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
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