Note: The job is a remote job and is open to candidates in USA. Kaztronix LLC is partnering with a growing biopharmaceutical organization seeking an experienced Senior Non-Clinical Editor to support regulatory submission activities. This role involves ensuring the quality and readiness of complex scientific and regulatory documents through thorough editing and quality control processes.
Responsibilities
- Perform comprehensive quality control reviews of scientific and regulatory documents to ensure accuracy, consistency, formatting, and submission readiness
- Copyedit and proofread documents for grammar, spelling, punctuation, style, and adherence to established editorial standards
- Verify consistency across text, tables, figures, appendices, references, and cross-references
- Ensure documents comply with submission templates and formatting requirements
- Prepare and publish submission-ready PDF documents, including bookmarking, hyperlinking, and document compilation
- Review and manage references within electronic document management systems
- Partner with Medical Writing, Regulatory Affairs, CMC, Toxicology, and other technical teams to deliver high-quality documentation under aggressive timelines
- Support continuous improvement initiatives related to document quality, publishing processes, and editorial standards
Skills
- Perform comprehensive quality control reviews of scientific and regulatory documents to ensure accuracy, consistency, formatting, and submission readiness
- Copyedit and proofread documents for grammar, spelling, punctuation, style, and adherence to established editorial standards
- Verify consistency across text, tables, figures, appendices, references, and cross-references
- Ensure documents comply with submission templates and formatting requirements
- Prepare and publish submission-ready PDF documents, including bookmarking, hyperlinking, and document compilation
- Review and manage references within electronic document management systems
- Partner with Medical Writing, Regulatory Affairs, CMC, Toxicology, and other technical teams to deliver high-quality documentation under aggressive timelines
- Support continuous improvement initiatives related to document quality, publishing processes, and editorial standards
- Bachelor's degree in English, Life Sciences, Business, or a related field (or equivalent industry experience)
- 4+ years of experience in pharmaceutical or biotechnology document quality control, regulatory editing, medical writing operations, or document publishing
- Demonstrated experience reviewing documents for regulatory submission readiness
- Advanced proficiency in Microsoft Word, including styles, templates, cross-references, and complex formatting
- Strong Adobe Acrobat skills, including PDF publishing, bookmarking, and hyperlink creation
- Experience using document management systems such as Veeva Vault, SharePoint, or similar platforms
- Exceptional attention to detail with the ability to identify inconsistencies and formatting issues
- Strong organizational, communication, and time management skills in a deadline-driven environment
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