Cactus Communications—a company dedicated to the pursuit of good English. We provide editing, educational, transcription, and training services to individual and institutional clients worldwide. All our businesses are linked together by one common factor—great written English. Since our establishment in April 2002, we have carved a niche for ourselves as a company providing language solutions of the highest quality.
Post : Quality Reviewer, Regulatory Writing
Job Description
- Review regulatory documents (e.g., protocols, amendments, IBs, CSRs, eCTD, summary documents, appendices, and clinical trial disclosures) for data accuracy against source data and consistency between the document text and the in-text tables.
- Review the content of the above-mentioned regulatory documents from a scientific and regulatory perspective
- Check for grammar, syntax, style, and compliance with style guides, regulatory guidelines, and publishing requirements
- Check documents generated by writers for data errors by checking annotated references
- Check documents generated by writers for fact errors (discrepancy between source data and document, discrepancy within text, discrepancy between figures/tables and text)
- Be responsible for the accuracy of data (numerical and otherwise) in the documents/projects assigned
- Ensure timely delivery of documents
Candidate Profile
- Minimum 3 years of experience in writing CSRs and/or other CTD sections either as part of a pharmaceutical regulatory writing team or in large, global CROs.
- A university degree (MBBS/MD/MS degree preferably in the pharmaceutical sciences) or equivalent industry experience
- Ability to work efficiently and independently, multitask, and prioritize
- Excellent attention to detail
- Ability to concentrate and work under pressure and meet tight deadlines
- Excellent written and oral communication skills
- Functional with Microsoft Word, Excel, and PowerPoint
- Flexible and adaptable to changing project priorities and work assignments
Additional Information:
Experience: 3 years
Location: Mumbai
Education: university degree (MBBS/MD/MS)
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Regulatory Writing
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