Global Biotech Clinical Documents Specialist
2 weeks ago
This role involves providing 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.
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 connecting professionals with opportunities in Life Sciences, Pharma, and IT. We offer flexible work arrangements and professional growth opportunities.
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