Spec , Medical Affairs

Medical Affairs Medical Writer

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.

Education & Experience:

• 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.

Skills:

• 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.