Kateric - Medical Editor - Remote
Kateric is a strategic partner for biopharmaceutical companies that consistently delivers superior quality regulatory documents through excellence, experience, and intelligent execution. Kateric's resources are located across multiple time zones in the United States, as well as in India, the EU and Canada, and also have experience working with client teams located across the globe.
About the Role
The Medical Editor is responsible for reviewing and substantively editing regulatory documents (e.g., clinical and/or nonclinical reports, including submission documents) in accordance with all relevant client and/or industry standards or guidelines. The Medical Editor may also be responsible for leading and organizing relevant review, approval, and publishing activities for nonclinical submissions. This may include but is not limited to ensuring adherence to client styles and formatting, managing stakeholder expectations, and ensuring timeline integrity across all nonclinical documents within the submission.
- Represent nonclinical editing as part of a global, cross-functional team and work independently to successfully review and edit each deliverable following the client business process.
- Proofread or substantively edit document(s) to correct and streamline grammar, spelling, punctuation, style, and format.
- Format, style, and troubleshoot functionality and presentation of documents and templates.
- Ensure compliance of document format per templates and style guides.
- Provide frequent and purposeful communication, ensuring all stakeholders are kept informed of progress and updates, as needed, in real time.
- Bachelor's degree within a relevant field, scientific degree is helpful.
- 3+ years of minimum experience with medical editing of clinical and/or nonclinical regulatory documents, preferably in the pharmaceutical industry.
- Knowledge and understanding of Good Publication Practices and clinical research process, including ICH GCP and FDA regulation.
- Mastery of the English language and relevant scientific terminology.
- Exceptional written and verbal communication skills.
- Superior attention to detail.
- Project/stakeholder management.
- Experience working with templates and style guides.
- Skilled (mastery level) in the following technologies:
- Microsoft Suite (Word, PowerPoint, and Excel)
- Adobe Acrobat/PDF software
- Document management systems and associated tools
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