Medical Writer

1970-01-01Davis Companieshttp://daviscos.com/wp-content/themes/davis_theme/assets/images/logo.svg325 Donald J. Lynch Boulevard, Suite 201MarlboroughMA01752USAcustomer support[+800-482-9494][+508-481-8519]
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Medical Writer

  • Specialty:

    Professional
    • City:

      Miami
    • State:

      FL
    • 33198
  • Assignment Type:

    Contract To Hire
  • Job Id:

    54338
  • Payrate:

    $36.71

Description

The Davis Companies is searching for a Medical Writer for their large medical equipment manufacturer located in Miami Florida.  This position additionally can be hired and work remotely!  This is a 12-18 month contract role which will report to the Global Clinical Compliance Manager and is looking to be filled immediately

Responsibilities of the Medical Writer:

  • Plan and execute systematic, scientific literature search, review, appraisal and report process for multiple in vitro diagnostic (IVD) products.
  • Compile and author Clinical Performance Reports (CPR) incorporating literature findings with clinical performance data from multiple sources in support of IVDR remediation project.
  • Collaborate with cross-functional team members (product management, regulatory, quality, R&D, program management) to communicate and escalate status of project milestones.
  • Support cross-functional questions regarding requirements for scientific validity, analytical and clinical performance, PEP/PER, PMS, PSUR and PMPF.
  • Support on time delivery of Performance Evaluation Plans (PEP), Performance Evaluation Reports (PER), Periodic Safety Update Reports (PSUR), Post-Market Performance Follow-up (PMPF) and PMS plans and reports, as needed per project timelines.
  • Author annual report updates and ensure data gathering, analysis, conclusions and reports are delivered on schedule as per Regulatory requirements.
  • Preparation of relevant information / responses for regulatory submissions and EUDAMED working with other members of the QA/RA department. Coordinate multiple projects at one time and provide regular reports to Management and other stakeholders as required. 

Requirements of Medical Writer:

  • Bachelor's degree required, Advanced degree preferred – scientific or medical focused.
  • Minimum 5 years of clinical evaluation, medical or scientific writing experience in an academic setting or the diagnostic, medical device or pharmaceutical industry.
  • Experienced in the use of scientific/clinical research methodology and databases. Knowledgeable of global regulations on clinical evidence required under IVDR or MDR.
  • Excellent technical writing skills.

#MON
#MINN-A

Quick Apply

  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
  • Accepted file types: pdf, doc, docx, txt, rtf.
  • By applying to this position and providing my contact information, I give The DAVIS Companies permission to provide me with email communications and information.

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