Sr Medical Writer - Exempt Sr Medical Writer - Exempt - Integrated Resources, Inc
Mounds View, MN 55112
About the Job
JOB DESCRIPTION
HM's Top 3:
HM's Top 3:
- Strong understanding of regulatory requirements & experience in writing regulatory reports including Clinical Evaluation Report (CER), Clinical Evaluation Plan (CEP), Post Market Clinical Follow-up (ProductF) Plan, ProductF- 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
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
Up to 40 hrs/week
Hybrid (3 days a week in the office if local to Minnesota), open to remote if out of state
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. 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.
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
Up to 40 hrs/week
Hybrid (3 days a week in the office if local to Minnesota), open to remote if out of state
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. 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.
Source : Integrated Resources, Inc