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Sr Medical Writer (Sr. Clin Evidence Specialist)

New Brighton, 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

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About New Brighton, MN

Discover exciting job opportunities in the vibrant area surrounding New Brighton, Minnesota! Nestled in the Land of 10,000 Lakes, this charming city offers a perfect blend of small-town charm and big-city amenities. With its close proximity to the Twin Cities, job seekers can enjoy a plethora of career growth opportunities while savoring the unique culture and picturesque beauty of the region. Explore local landmarks like Long Lake Regional Park, catch a show at the historic Mounds Theatre, or cheer on the Minnesota Twins at Target Field. Don't miss out on the delectable cuisine, art galleries, and outdoor recreation this area has to offer. Take the next step in your career journey and browse our job listings in New Brighton, MN today!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.