Clinical Evaluation Report Medical Writer

hace 2 semanas

Desde casa, Colombia Criterion Edge A tiempo completo

**Clinical Evaluation Report Medical Writer**

**Job Type**:Part-Time, Contractor, Fully Remote Position

**Experience Level**: Experienced

Criterion Edge (CE) is seeking a remote contractor for the Clinical Evaluation Report (CER) Regulatory Writer role. The position is responsible for providing regulatory writing expertise for the development of initial and annual update CERs that support the overall global regulatory submission requirements for the client’s portfolio of medical device products. **Please note that previous CER writing experience is required for this role.**

**Specific responsibilities include**:

- Prepare regulatory documents and responses to regulatory authorities, specifically working on Clinical Evaluation Reports (CERs) and associated documents (CEP, SSCP, PMCFP, etc).
- Combine understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with MEDDEV 2.7/1 Rev 4, MDD, AIMDD, and EU MDR 2017/745.
- Collaborate with the client and Criterion Edge Librarian to build relevant literature searches for assigned projects (identify relevant key words, design search and selection strategies, etc), perform literature screening against inclusion/exclusion criteria, extract data from included studies, interpret study results, synthesize literature, and prepare summaries into formal reports) for specific medical devices and associated therapeutic fields.
- Perform comprehensive evaluation of device data within the context of the therapeutic field.
- Serve as the regulatory writer on assigned CER projects, collaborating with the CE Project Lead to meet all project deliverable timelines
- Ensure documents are produced in accordance with procedures, internal and external guidelines, and electronic templates

**Required Experience**:

- ** Previous experience writing CERs and related documents in accordance with EU MDR 2017/745 and 4, including execution and writing of state-of-the-art literature reviews**:

- Strong command of medical and surgical concepts and terminology
- Demonstrated independent execution of systematic literature reviews of available therapeutic or diagnostic treatment options, including search and selection, extraction, synthesis, and structured written presentation of data
- Demonstrated ability to identify and adapt to shifting priorities and competing demands
- Proficiency in document development and management using Word, Excel, PowerPoint and EndNote
- Training and degree in science, engineering, or medical fields. Scientific/research background (i.e., understands research design, methodology, and statistics)

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