Medical Affairs​/Medical Writer

Position :
Medical Affairs/Medical Writer Location :
Sandy, UT Duration : 12 Months Total Hours/week : 40.00

Client:
Medical Device Company Job Category:
Medical / Clinical Affairs Level Of

Experience:

Mid-Level

Employment Type:

Contract on W2 (Need US Citizens or GC Holders Only)
Job Description

• 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.
• 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 and with the Senior Medical Writer as necessary to ensure accurate and timely completion and review of clinical documents for regulatory submissions.

• Minimum of a bachelor's degree required.
• Experience in a relevant Medical Device Industry required
• Minimum of 2-3 years writing experience within the Medical Device Industry.
• 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.

Millennium Soft Inc