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Medical Writing Specialist - Transcatheter Heart Valve (USA Remote Position)

Company: Edwards Lifesciences Corp
Location: Irvine
Posted on: May 3, 2021

Job Description:

Edwards is the global leader in transcatheter heart valve replacement technologies designed for the nonsurgical replacement of heart valves. Delivered via catheter while the heart is beating, these valves can enable patients to experience a better quality of life sooner than patients receiving traditional surgical therapies. Launched commercially in Europe in 2007, and in the United States in 2011, our transcatheter aortic heart valves are now available in more than 70 countries and are the most widely used transcatheter heart valves in the world.

The Medical Writing Specialist will act as a primary contact for medical writing projects, working with other cross-functional Edwards departments and clients to set and meet internal and external deliverable timelines

Essential Job Functions & Key Responsibilities:

  • Develop medical writing documents/deliverables for assigned project(s) (e.g., IDE annual reports, Clinical Study Reports, etc.)
  • Serve as the primary contact, negotiating deliverables, timelines, and resolving project-related issues in collaboration with cross-functional stakeholders
  • Conduct literature searches and reviews including developing search strategy, manage associated documentation, and prepare literature summaries
  • Provide input on other cross-functional deliverables utilizing technical knowledge
  • Identify, recommend, and assist in the implementation of continuous process improvements as it relates to medical writing
  • Other incidental duties assigned by Leadership

Minimum Requirements:

  • Bachelor's Degree with 3 years of medical writing experience; or MS/PhD degree with relevant graduate research or post-doc experience
  • Familiarity and/or experience with literature searches and reviews for PubMed; and reference management software (e.g. EndNote or Distiller)
  • Advanced user of MS Word (e.g., formatting, templates).

Preferred Qualifications:

  • MS or PhD degree
  • Medical Device, Pharma, or Biotech industry experience
  • Experience in cardiology or interventional cardiology therapeutic areas
  • Knowledge of FDA regulations or MedDev/EU MDR regulations

Additional Talents & General Expectations:

  • Ability to travel up to 10% of the time to conferences and/or to our Irvine, CA corporate office
  • Proven expertise in Microsoft Office Suite including Word, PowerPoint, and Excel
  • Good written and verbal communication skills and interpersonal relationship skills
  • Good problem-solving, organizational, analytical and critical thinking skills
  • Moderate knowledge and understanding of policies, procedures and guidelines relevant in the development of scientific content and medical writing
  • Strict attention to detail

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Keywords: Edwards Lifesciences Corp, Irvine , Medical Writing Specialist - Transcatheter Heart Valve (USA Remote Position), Other , Irvine, California

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