Medical Device Writer Specialist (CER)

Minneapolis, MN

Job ID: 122664 Industry: Med

Medical Device Writer Specialist (CER)

Job Duties/Responsibilities:

This project will be supporting one of the largest medical device companies in the world with the remediation of their Clinical Evaluation Reports. The Medical Writer Specialist is responsible for the preparation of documents that support the presentation and/or publication needs of assigned areas and/or medical devices in the clients Strategic Medical Affairs Team for a wide range of audiences.

Key Job Activities:
  • Primarily focuses on preparing, writing, editing, and reviewing regulatory (e.g. Clinical Evaluation Reports (CERs), clinical data reports or summaries) documents and responses to regulatory authorities (e.g. notified bodies).
  • Participates in post-market surveillance activities by conducting routine systematic literature reviews (e.g. screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical device groups or sub-groups.
  • Performs scientific writing (e.g. abstracts, manuscripts, presentations).
  • Organizes and incorporates information for documents, such as references, graphics, tables, and data listings.
  • Ensures documents are produced in accordance with procedures, internal and external guidelines (e.g. MEDDEV 2.7.1), and electronic templates.
  • Reviews and provides input on clinical data being considered for presentation and/or publication to ensure alignment with scientific strategies and corporate goals.
  • Expert knowledge of clinical research, device/drug development processes, regulatory requirements, good clinical and data management practices.

 Required:
  • Experience writing CERs (start to finish)
  • Scientific/clinical background
  • Medical writing
  • Understanding of statistical analysis
  • BS degree

Plus:
  • Master’ s Degree or PHD

Job Type: Contract  

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