Associate Medical Writer, Medical Affairs Request ID: Req-22989 Location: USA, California, Irvine

Company: Edwards Lifesciences
Location: Irvine
Posted on: March 18, 2023

Job Description:

Associate Medical Writer, Medical Affairs Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring with a rapidly growing portfolio of innovative and less invasive solutions.The Transcatheter Mitral and Tricuspid Therapies (TMTT) division is passionate about developing breakthrough solutions for patients with Mitral and Tricuspid Valve disease. The Associate Medical Writer is an opportunity to join this rapidly growing, fast paced, dynamic TMTT Medical Affairs team and will play a pivotal role in supporting medical writing projects -- working with the Medical Writing/Clinical Science team and other cross-functional Edwards departments to meet internal and external deliverable timelines.This role is known internally titled as Associate Specialist, Medical Writing, and is an onsite role based at Edwards' corporate headquarters in Irvine, California.Essential Job Functions/Key Responsibilities:

• Draft, edit, proofread, and perform quality checks for, medical writing documents/deliverables for assigned project(s)
• Edit, proofread, perform quality checks, and manage ClinicalTrials.gov submissions
• Assist team with basic literature searches, manage the literature database and prepare literature reviews for clinical science team
• Set up and maintain applications that facilitate Medical Writing/Clinical Science processes (e.g. SharePoint, ClinicalTrials.gov submissions,document review software, literature review software, and reference management software)
• Collaborate with team members to provide input on other cross-functional deliverables (e.g., risk management review, IFUs, SSED) utilizing technical knowledge
• Support the primary contact with negotiating deliverables, timelines, and resolving project-related issues in collaboration with members of the team and cross-functional stakeholders to ensure alignment
• Other duties as assignedMinimum Requirements:
  • Bachelor's degree in related field with 1 year of previous related experience in medical writing.Preferred Qualifications:
    • Good editing and proofreading skills
    • Strict attention to detail
    • Good computer skills in Microsoft Office Suite including Word, PowerPoint, Access, and, Excel, and other applications such as SharePoint and Adobe Acrobat
    • Familiarity with clinical research
    • Familiarity with US and EU regulatory requirements
    • Good written and verbal communication skills and interpersonal relationship skills
    • Good problem-solving, organizational, analytical, and critical thinking skillsAdditional Talents and General Expectations:
      • Familiarity with policies, procedures and guidelines related to the development of scientific content
      • Familiarity with policies, procedures, and guidelines relevant in the development of scientific publications and medical writing styles and techniques
      • Good knowledge of medical writing
      • Familiarity with medical literature databases (e.g., PubMed, EMBASE)
      • Ability to interact professionally with all organizational levels
      • Ability to manage competing priorities in a fast paced environment
      • Ability to work in a team environment, including immediate supervisor and other team members in the section or group
      • Ability to build stable working relationships internally
      • Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/controlAligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.For California, the base pay range for this position is $64,000 to $91,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

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