Closely working with medical writers and clinical physicians tocontribute to clinical study related medical writing activities to meetcustomer’s clinical trial project needs. He / she will carry outday-to-day hands-on work and maintain good medical writing relationshipswith project related stakeholders internally and externally.
- To work directly with medical writing manager, clinicalphysician,biostatistician, programmers, or relevant parties involved inall medical writing activities.
- To carry out hands-on medical writing in accordance with company SOPsand GCP.
- To participate in the discussion and drafting the clinical developmentplan and editing
- To prioritize and plan workload to a high standard
- To work directly with medical team and clinical research physician tocarry out clinical study related medical writing including IB, studysynopsis, protocol, CSR, clinical document translation.
- To search product, target indication with market analysis and report
- To be involved in the preparations on the documentation for regulatorysubmissions (e.g. investigator brochures, protocols, and CSR).
- Develop and maintain solid knowledge of the relevant therapeutic areasand medical writing techniques.
- To undertake any activities involving writing and communication withothers, internally and externally, as requested.
Professional Experience & Education Requirement
- Bachelor degree in Medicine, pharmacology or other life sciencedegrees (or equivalent)
- Understand clinical trial operation process
- Excellent Chinese and English written and verbal communicationskills;excellent scientific and technical writing skills in both Chineseand English.