Spec 2, Medical Affairs
Company: Calsoft Labs
Location: Sandy
Posted on: August 3, 2022
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Job Description:
Job DescriptionThe position will be remote.The 3 must have
qualities for a Medical Writer are:-Ability to cross reference
multiple documents-Attention to Detail-FlexibilityJob 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 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.
Keywords: Calsoft Labs, Sandy , Spec 2, Medical Affairs, Other , Sandy, Utah
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