Medical Affairs/Medical Writer
Medical Affairs/Medical Writer
MillenniumSoft Inc
Sandy, UT
See who MillenniumSoft Inc has hired for this role
Position : Medical Affairs/Medical Writer
Location : Sandy, UT
Duration : 12 Months contract
Total Hours/week : 40.00
Client: Medical Device Company
Job Category: Medical / Clinical Affairs
Level Of Experience: Mid-Level or Senior Level
Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)
Job Description
Location : Sandy, UT
Duration : 12 Months contract
Total Hours/week : 40.00
Client: Medical Device Company
Job Category: Medical / Clinical Affairs
Level Of Experience: Mid-Level or Senior 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.
-
Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Health Care Provider -
Industries
Staffing and Recruiting
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