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Clinical Medical Writer

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Location
MN
Job Type
Direct Hire
Date
Oct 26, 2018
Job ID
2635879
Our mid-sized medical device client has created a new role for a Clinical Evaluation Report Writer! This role will report to the Director of Clinical and have a lot of visibility to the leadership team and able to make a huge impact on the business.
The CER Writer will be responsible for gathering, analyzing, and generating global clinical evidence for both the Ortho/Spine areas.  Support of development of regulatory clinical evaluations, as well as clinical summaries for submissions to regulatory bodies. Additional duties include reviewing existing literature and providing summaries when requested, clinical evidence gap analysis, clinical study report development and set publication plans.

Your role with the company:
 
  • Development and creation of the Clinical Evaluation Reports for submissions to regulatory bodies, including the EU, US and various APAC regulatory entities. Includes interfacing with Quality, Regulatory Affairs, Legal, and product development.  Conducts scientific literature reviews for regulatory compliance purposes, per SOP (Clinical Evaluation Reports).
  • Cultivates collaborative relationships with current and future thought leaders in academic and clinical practice at the local, regional, national, and international level.
  • Works internally to obtain input on the publication plan and updates regularly to address evidence gaps
  • Evaluates external research proposals for scientific soundness. · Development and ownership of scientific evidence toolkit. · Works closely with Professional Marketing and Clinical Education teams to provide scientific evidence to support NA strategies. · Ownership of the development of NA white papers.
  • Ownership of publications library (EndNote).
  • Advanced degree in science, medicine, or dentistry preferred.
  • Experience in technical writing such as clinical study plans, clinical reports, scientific manuscripts, clinical evaluation reports.
  • Experience in assessing medical evidence.
  • Familiarity with Good Publication Practices.
  • Strong critical thinking and analytical skills with proficiency in managing multiple tasks.
  • Demonstrated ability to identify issues and implement solutions, including identifying and involving the appropriate decision makers.
  • High attention to detail and accuracy.
  • Working experience with clinical and outcomes research study design, Good Clinical Practices, and global clinical regulations, including FDA regulations and industry guidelines for devices.
  • Strong interpersonal skills including communication, collaboration and negotiation capabilities.
  • Ability to independently set and manage multiple competing priorities while guiding others.
Background Profile:
  • Knowledge of research methodology (including clinical investigation design and biostatistics)
  • Have experience in relevant databases (e.g. Emabase and Medline) to be able to complete thorough systematic literature reviews and clinical summaries
  • Understand regulatory requirements, (e.g. MEDDEV 2.7/1 rev 4, upcoming MDR)
  • Training and experience in medical writing and data appraisal
  • Medical knowledge with expertise in areas of the device technology and applications
  • A degree of higher education in the respective field and 5 years of documented professional experience or 10 years of documented professional experience if a degree is not a prerequisite