English

Position Title:Medical Writing Project Manager/Manager
Department:Clinical Development
Location:Shanghai

Position Summary

Work with medical and clinical physician team to manage clinical study related medical writing activities, and meet customers’ project needs. This role will build and maintain good medical writing relationships across all functionas. With the opportunities to be exposed to a diverse portfolio of clients, this role will also undertake activities involving writing and communication with relevant parties internally and externally.

Key Responsibilities

  • Conduct and manage medical writing activities
  • Manage and carry out clinical study related medical writing including IB, study synopsis, protocol, CSR, clinical document translation, etc.
  • Ensures all final document adheres to SOP, good clinical practice (GCP), and the international conference on harmonization (ICH).
  • Plan, schedule, review, approve, and track all assigned medical writing activities in close cooperation with the teams to ensure deliverables meet project specification, within timelines to defined quality, and content standards at each point in the document life cycle.
  • Act as the primary client’s contact for medical writing projects.
  • Perform literature searches for drafting document content. Interpret literature information and make recommendations for application to clinical regulatory documents.
  • Search product, target indication with market analysis and report
  • Work with Quality Assurance throughout clinical regulatory document audit process.
  • Manage and work on document preparation for regulatory submissions in collaboration with regulatory and BD teams under client specifications.
  • Assist the training for junior medical writers, may supervise team members as requested
  • Develop and maintain scientific and clinical trial knowledge, as well as relevant therapeutic areas and medical writing techniques and capabilities.
  • Lead and conduct any activities involving writing and communication with others, internally and externally, as requested

  • Education and Key Competency Requirement
    Professional Experience & Education Requirement

  • Minimum Bachelor degree in Medicine, pharmacology, or related life science degrees (or equivalent); Master will be a plus.
  • 4+ years of experience in medical writing or clinical science or equivalent fields in biopharmaceutical or CRO companies, plus solid experience in complex project management or large scale registration trail projects

  • Key Competency Requirement

  • Solid knowledge in clinical research process and understand submission requirements
  • Project management and organizational skills.
  • Excellent scientific and technical writing skills in both Chinese and English
  • Proactively seeks out process improvements, efficiencies, and innovations.
  • Detail oriented to consistency, grammar, syntax, and scientific accuracy for deliverables.
  • Well-developed of time management, communication, presentation, analytical and interpersonal skills.
  • To have a detailed knowledge of the regulatory guidance for ICH/GCP
  • Excellent Chinese and English written and verbal communication skills
  • Proficient in the use of Word, Excel, PowerPoint, PDF, etc. and applications for medical writing
  • Customer oriented and proactive working attitude
  • Self-initiative for continued enhancement of quality, process and skills
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