Regulatory Quality Control Specialist

The opportunity:

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 QC specialist who wishes to be part of a world-class delivery team, and work in an exciting, fast-paced global environment.

 

Responsibilities:

  • 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

 

Requirements (Desired skills & experience):

  • Minimum 2-5 years experience in performing QC review of regulatory/scientific documents
  • A university degree (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

Job location : 
Remote, anywhere in India

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Cactus Communications Pvt. Ltd.
B-502, Satellite Gazebo, Guru Hargovindji Marg,
Andheri (East), Mumbai - 400093, India
Phone: +91–22–67148888 Fax: +91–22–67148889