Posted 3 years ago

Key responsibilities

  • Author and review clinical and regulatory documents such as Study Protocols, ICFs, CSRs, IBs, Paediatric Investigation Plans, Briefing Books, Requests of Product Specific Waivers, applications for Orphan Drug Designations, and responses to Health Authorities; the documents should be accurate, suited for the intended audience and easy to read
  • Review work of other writers (contractors or internal functional area representatives) for accuracy, quality, focus, and adherence to format and stylistic requirements
  • Drive process improvement and/or cross-functional initiatives (e.g., SOP review, template development)
  • Develop the strategy for document preparation and the document review processes: you collaborate closely with the teams to better understand the needs, the planning, and timelines & facilitate document review meetings and discussions
  • Provide advice in the development and implementation of best practices in medical writing
  • Trigger annual IB reviews and updates
  • Collaborate closely with internal specialists/colleagues/departments to obtain/provide information, ensure smooth review processes, incorporate editorial comments, and solve queries to present a ‘finished’ final document within the required deadline
  • Ensure understanding and implementation of international quality standards (ICH GCP) and internal company procedures
  • Facilitate document review meetings and discussions
  • Contribute to the development of project timelines

Your profile

  • Master’s Degree required, advanced Clinical/Science Degree is preferred (e.g. PhD, MD, etc.).
  • 5 years experience supporting the development of Study Protocols, Protocol Amendments, Briefing Books, IBs, CSRs or ICFs in Pharmaceuticals
  • Strong experience of writing guidelines (e.g. EMA, FDA, ICH, AMA, etc.) used for the preparation of clinical documents
  • Strong working knowledge of the clinical drug development process, clinical trial design and biostatistics
  • Strong experience integrating information into clinical and regulatory documents
  • Fluency in English and solid writing/editorial skills
  • Ability to prioritize and manage multiple demands and projects within deadline
  • Good command of MS Word
  • Good presentation skills and ability to interpret and present data in a logical manner
  • Self-starter, flexible in adapting to changing circumstances or new information, able to adapt quickly in a fast-moving environment.
  • Attention to detail, accuracy, and logical organization. Expert grammatical and communication skills, both written and oral

Job Features


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