Position: Medical Writer
Location: Sandy, UT
Duration: 12+ Months Contract
Total Hours/weeks: 40.00
Position starts out remote, but candidate must be local.
3 Must haves on the resume:
o Minimum of a Bachelor’s Degree required.
o Experience in a relevant Medical Device Industry required
o Minimum of 2-3 years writing experience.
Job Title: Medical Writer
Job Description Summary Medical Affairs is responsible for ensuring the safety and efficacy of Medication Delivery Solutions (MDS) products worldwide. The Medical Writer will support this mission by assisting with and / or compiling, reviewing and summarizing, available data to access the safety and efficacy of MDS products worldwide.
Job Description: The Medical Affairs Medical Writer will combine their knowledge of science with their understanding of research and writing to present information effectively and with clarity. The Medical Writer will focus on scientific medical writing to prepare documents – clinical evaluation plans (CEPs) and clinical evaluation reports (CERs) – for submission to regulatory bodies. The Medical writer will collaborate with other functions as necessary to ensure accurate and timely completion and review of clinical documents for regulatory submissions. The Medical Writer will be expected to assist with comprehensive literature searches as needed regarding subject medical devices.
Education & Experience:
• Minimum of a Bachelor’s Degree required.
• Experience in a relevant Medical Device Industry required
• Minimum of 2-3 years writing experience.
• Certification through the American Medical Writing Association (AMWA) or other relevant association is preferred.
• Superior attention to detail.
• Ability to write with scientific accuracy
• Ability to compile, write, edit, and format documents for submission to regulatory agencies. (Writing samples required)
• Ability to assist with comprehensive literature searches as needed.
• Understanding of MEDDEV 2.7/1 rev4 guidelines and the MDR regulations related to clinical evaluation reports preferred.
• Ability to ensure that all deliverables are in accordance with applicable regulations, standards, and guidelines
• Excellent written and verbal communication skills.
• Proficiency in MS Office with expertise in Microsoft Word with a special focus on word processing, use of templates, and formatting. Working knowledge of Excel.
• Proficiency with a PC
• Excellent time management skills, and ability to meet deadlines
• Working knowledge of statistical concepts and techniques.
• Experience in working with collaborative, cross-functional teams.
• Ability to function well both individually and as part of a team.
• 40 hour / week
We provide man power in different job categories like admin, clerical, accounting, financial, light industrial, heavy industrial, engineering, professional and health care.
Why Work Here?We at Millenniumsoft staffing vertical serves our clients with contingent workforce, recruitment staffing, payroll staffing, contract to hire, temporary hire and direct hire as service. We provide man power in different job categories like admin, clerical, accounting, financial, light industrial, heavy industrial, engineering, professional and health care.
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