Quality Reviewer,Regulatory Writing
The medical writing team at CACTUS works with multinational pharmaceutical companies, clinical research organizations, and researchers worldwide to help them communicate their science. We are currently looking to add to our team, an experienced regulatory writer who wishes to be part of a world-class delivery team, and work in an exciting, fast-paced global environment.
As part of his/her key responsibilities, the Quality Reviewer at CACTUS will
- 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
This position requires:
- 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 or masters 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
Location: Andheri (West), Mumbai
To apply, send in your CV's to email@example.com or call on 022-67148888.