Freelance Regulatory Specialist
The medical communications team at CACTUS supports a majority of the Top 10 global pharmaceutical companies across a wide range of communications needs including writing, graphics, animation, and strategy for their regulatory and publications teams.
As part of his/her key responsibilities, the Freelance Regulatory Specialist 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
- 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 5 years' of writing and reviewing experience with regulatory documents such as protocols, IBs, CSRs, eCTD sections, RMPs, PSURs, etc.
- A university degree (Bachelor’s/Master’s 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
Please send in your application to email@example.com.