Medical Writer - Miami


Detalles del trabajo

Area del puesto: Servicios Generales / Varios

Publicación: hace 4 dias
Ubicacion del puesto: Florida - Estados Unidos
Trabajo remoto: No
Our client, a leading Medical Devices company is looking for a Medical Writer . This is for an initial duration of 12 months and is located in Miami, FL
Primary Responsibilities:
  • Plan and execute systematic, scientific literature search, review, appraisal and report process for multiple hematology and Urinalysis in vitro diagnostic (IVD) products.
  • Compile and author Scientific Validity (SVR) and Clinical Performance Reports (CPR) incorporating literature findings with clinical performance data from multiple sources in support of IVDR remediation project.
  • Provide critical thinking and analysis of conclusions drawn from clinical evidence to ensure intent of the Regulation is being met.
  • 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.
  • Provide critical review of the clinical evidence compiled for the PER by other functional team members to meet the applicable regulatory requirements.
  • Support on time delivery of Performance Evaluation Plans (PEP), Performance Evaluation Reports (PER), as needed per project timelines.
  • 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.
  • Perform additional scientific writing assignments or duties as assigned.

  • Position Qualifications:
  • 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.
  • Ability to work in a fast-paced environment with effective use of prioritization, organization and time management skills.
  • Excellent communication and interpersonal skills with the ability to communicate clearly and concisely in English.
  • Proven problem-solving skills.
  • Excellent technical writing skills.

  • Qualified candidates please send your word format updated resume at the earliest to . Thank You.

    Sobre el Anunciante
    Sunrise Systems | Neuvoo
    Estados Unidos

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