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Green Key Resources

Medical Writer - Medical Device

Post Date:Jan 08, 2018Type:Contract to Hire
Start Date:12/27/2017Salary:
Location:US-MA-Mansfield Job Reference:
Skills:

- Medical/Scientific writing experience
- Regulatory (submissions, notified bodies, regulations, reg associates)
- Clinical (clinical research managers, CRAs, clinical compliance, hospital research coordinators, grant writers)
- EU Regulation experience, Med Device Regulations, Med Device Directive



Job Description:

• Collaborate (writing, reviewing, editing, approval) with stakeholders from Clinical, R&D, Quality and Regulatory teams on clinical evaluation reports (CER), clinical impact assessments, post market surveillance reports, and other documents that require the evaluation of clinical data and/or clinical literature 
• Conduct proofreading, editing, document formatting, review comment integration and document completion/approval activities 
• Work with other functional groups (Marketing, R&D, Regulatory) to identify competitor devices and to understand state-of-the-art for the therapy area and product line 
• Develop and maintain therapeutic and device operation knowledge literature required to support identified product lines and related clinical studies, stay informed about applicable clinical landscapes and trends; apply this knowledge to the development of well-written, clear and concise reports 
• Work with Knowledge Center librarian(s) and other data retrieval specialists to develop literature or data search strategies 
• Actively participate, review and give input into development of post-marketing surveillance (PMS) and post-marketing clinical follow up (PMCF) plan 
• Actively participate, reviews and gives input into developing or updating risk assessments 





Contact Information
Green Key Resources



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