1. Draft, review, and finalize clinical study documents in compliance with ICHGCP,
applicable regulatory guidelines, and sponsor specifications, including
but not limited to:
▪️Clinical study protocols and protocol amendments
▪️Investigator’s brochures (IB) and IB updates
▪️Clinical study reports
▪️Informed consent forms
▪️Briefing documents for regulatory meetings
▪️Patient narratives and safety summaries
▪️Clinical sections of regulatory submissions (e.g., CTD Module 2.5, 2.7)
2.Ensure scientific accuracy, clarity, and consistency of content across all
documents
3.Collaborate cross-functionally with biostatistics, data management, clinical
operations, medical affairs, pharmacovigilance, and regulatory affairs teams
Interpret statistical and clinical data for integration into reports and summaries
4.Follow internal SOPs, writing style guides, and client-specific templates or
standards
5.Maintain awareness of current regulatory requirements and industry best
practices in clinical documentation
6.Assist in developing and maintaining document timelines, ensuring timely
delivery
7.Respond to quality control or medical/scientific review comments and
incorporate revisions accordingly
8.Hold PI meetings, and present protocols and clinical trial results to PIs and
relevant personnel
9.Undertake other MA-related tasks as assigned by the line manager