Senior Medical Editor
1 week ago
As a Senior Medical Editor at Lifelancer, you will be part of a global mid-sized biotech company, fully embedded with our client. This home-based position is open to candidates in Europe or the UK.
This role is responsible for quality control 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.
Key Responsibilities:- Perform QC review of documents (e.g., clinical study protocols and amendments, clinical study reports [CSRs], Investigator's 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 company style guides.
- Ensure internal consistency and confirm that data are reported correctly, statements accurately reflect source documents or data (e.g., 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 cross-referenced 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.
Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talent with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains. For job application and quicker response, please use the below Lifelancer link.
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