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Position Title:Medical Writing Specialist/Senior Specialist
Department:Clinical Development
Location:Shanghai

Position Summary

Closely working with medical writers and clinical physicians to contribute to clinical study related medical writing activities to meet customer’s clinical trial project needs. He / she will carry out hands-on work and maintain good medical writing relationships with project related stakeholders internally and externally.

Key Responsibilities

  • Work directly with medical writing manager, clinical physician, biostatistician, programmers, or relevant parties involved in all medical writing activities.
  • Carry out hands-on medical writing in accordance with company SOPs and GCP.
  • Participate in the discussion and drafting the clinical development plan and editing
  • Work with medical team and physician to carry out clinical study related medical writing such as IB, study synopsis, protocol, CSR, clinical document translation, etc.
  • Search product, target indication with market analysis and report
  • Support the preparation of documents for regulatory submissions (e.g. investigator brochures, protocols, and CSR).
  • Develop and maintain solid knowledge of relevant therapeutic areas and medical writing techniques.

  • Education and Key Competency Requirement
    Professional Experience & Education Requirement

  • Bachelor degree in Medicine, pharmacology or other life science degrees (or equivalent)
  • For Specialist, 2+ years of experience in medical writing or clinical science or relevant experience in biopharmaceutical or CRO companies
  • For Senior Specialist, 4+ years of experience in medical writing, clinical science or relevant experience, plus complex and large scale project management experience in biopharmaceutical or CRO companies

  • Key Competency Requirement

  • Understand clinical trial operation process
  • Have good knowledge of the regulatory guidance for ICH/GCP
  • Excellent Chinese and English written and verbal communication skills; Excellent scientific and technical writing skills in both Chinese and English
  • Ability to write fluent and grammatically correct English with solid understanding of medical and scientific terminology and procedures
  • Ability to work to tight timelines and changing needs while maintaining accuracy and quality
  • Ability to work to a variety of client-driven specifications
  • Customer oriented
  • Attention to detail and proactive working attitude
  • Ability in issue identification and problem solving
  • Apply for the position
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