Remote Medical Writer

• 5000 - 6000 USD per Month
• Full Time
• Posted : 11 months ago

Summary

• Prepare and/or assist in the preparation of Clinical Evaluation documents in accordance with the EU using relevant information compiled from research, peer-reviewed publications, risk management files, & post-market data.
• Summarizes findings and drafts risk vs benefit analyses and conclusions, for review by a Sr Medical Writer, based on clinical and post-market data in accordance with the EU
• Perform and/or assist in the comprehensive literature searches and clinical evidence mapping to develop and maintain in-depth knowledge and understanding of current scientific literature required to support identified product lines and related pre-clinical and clinical studies.
• Prepare and/or assist in the preparation of reviews of peer-reviewed literature for inclusion in post-market surveillance plan for general and product-specific PSP reports.
• File and/or assist in filing work in the Clinical Evaluation archives, provide documentation & clinical data searches to various departments, and provide verbal and/or written progress reports monthly.
• Distribute and/or assist in distributing reviewed final draft reports to Clinical Affairs, Regulatory Affairs, Post-Market Surveillance and Development Engineering groups to verify and approve content of final draft document.
• Manage and/or perform additional tasks and projects, as assigned

• BA or BS Degree
• 5+ years of strong Medical Writing Experience
• Experience in the development of clinical, scientific, and regulatory documents
• Experience conducting systematic literature reviews
• Demonstrated bibliographic research and editorial skills
• Experience writing and reviewing Clinical Evaluation Reports (CERs) and Clinical Evaluation Plans (CEPs)
• Strong ability to organize, interpret and disseminate relative product information (to analyze clinical research data)
• Ability to apply statistical knowledge and distinguish what pertinent Clinical data can be utilized in support of business initiatives.
• Ability to build and maintain strong relationships with business partners on all levels.
• This position requires an individual who is self-motivated, but happy to work as part of an extended team.
• Basic understanding with FDA compliance for medical devices
• Proficiency in MS Office (Word, Excel, PowerPoint)
• Excellent verbal, proofreading medical writing, and editing skills, and a keen attention to detail
• Ability to communicate to medical device industry professionals and customers
• Can work independently, set the right priorities and is a self-starter.

• Advanced degree in a scientific discipline (preferred - Ph.D., MD, or Pharm.D.)
• Experience with MEDDEV 2.7/1 Rev 4 and EU MDR Standards
• Experience with PMCF Plans & Reports and CERs
• Experience with Medical Device or Pharma Regulations relative to Clinical Research is preferred
• a background in spine or orthopedics
• Expertise in conducting focused literature searches on PubMed, Medline or other similar medical literature databases.
• Basic understanding with FDA compliance for medical devices
• Experience conducting systematic literature reviews

• Start ASAP
• 6+ month engagement
• Remote

Skills

• Medical Writing
• Literature
• Clinical Trials
• Proofreading
• Clinical Data