Senior Medical Editor
Senior Medical Editor
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Job Description
As a Senior Medical Editor you will be supporting a global midsized biotech company. While being stably employed with ICON you will be fully embedded with our client.
The position is home based anywhere in Europe or UK. Your contribution will be in the field of solid and liquid tumors. While working for our client you will be able to profit from ICON through continued learning opportunities and building a longerterm career.
This position is responsible for quality control (QC) review of clinical documents intended for submission to health authorities worldwide. The Senior Medical Editor will copyedit/proofread format and verify data content in clinical documents in accordance with SOPs and processes to ensure documents meet required standards and may oversee the workload for the editors establishing schedules and interacting with crossfunctional authors. The Senior Medical Editor performs the activities with minimal oversight needed
What you will be doing:
- Perform QC review of documents (eg clinical study protocols and amendments clinical study reports CSRs Investigators Brochures and Module 2 clinical summary documents) to ensure compliance with the Style Guide and submission standards.
- Verify data in documents against the source tables figures and listings and format tables according to standards.
- Copyedit/proofread clinical documents for grammar style and formatting according to AMA and companyys style guides.
- Ensure internal consistency and confirm that data are reported correctly statements accurately reflect source documents or data (eg SAS tables and listings).
- Check reference list in documents including verifying citation information vs PubMed ordering copies of references and adding to the electronic document management system (EDMS) and ensuring each reference is crossreferenced in the document.
- Proofread documents against the standard templates to ensure compliance with required sections and text.
- Perform publishing of nonclinical and clinical documents and the compilation of required CSR appendices as needed.
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Remote Work :
No
Employment Type
Full Time
