2 Medical Affairs Spec 2 Jobs in Sandy, UT
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Medical Affairs Spec 2
$64k-82k (estimate)
Full Time | IT Outsourcing & Consulting
3 Weeks Ago
millenniumsoft is Hiring a Medical Affairs Spec 2 Near Sandy, UT
Medical Devices Company
Position : Medical Affairs Spec 2Location : Sandy, UTDuration : 12 Months Total Hours/week : 40.00Client: Medical Device CompanyJob Category: HealthcareLevel Of Experience: MidlevelEmployment Type: Contract on W2 (Need US Citizens Or GC Holders Only)
Position : Medical Affairs Spec 2Location : Sandy, UTDuration : 12 Months Total Hours/week : 40.00Client: Medical Device CompanyJob Category: HealthcareLevel Of Experience: MidlevelEmployment Type: Contract on W2 (Need US Citizens Or GC Holders Only)
- The position will be remote.
- Ability to cross reference multiple documents
- Attention to Detail
- Flexibility
- Remote
- 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.
- 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.
- Minimum of a Bachelor’s Degree required.
Job Summary
JOB TYPE
Full Time
INDUSTRY
IT Outsourcing & Consulting
SALARY
$64k-82k (estimate)
POST DATE
05/31/2024
EXPIRATION DATE
07/22/2024
WEBSITE
gomillenniumsoft.com
HEADQUARTERS
FAIRFAX, VA
SIZE
50 - 100
FOUNDED
2000
CEO
SHAILAJA MASHETTY
REVENUE
$5M - $10M
INDUSTRY
IT Outsourcing & Consulting
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