General Summary

• Researches, writes, and edits clinical documents, including clinical study reports, clinical study protocols, clinical plan outlines, sections of regulatory submission documents, and scientific manuscripts by applying therapeutic expertise and clinical drug development knowledge and relevant experience to the development of drugs, biologics, devices and or other products for human use. May provide writing support for more complex clinical documentation, with appropriate departmental supervision. May serve as primary technical contact with client.

Accountabilities

• Writes, reviews, and edits scientific manuscripts, clinical study reports, plan outlines, protocols, documents for regulatory submissions, investigator brochures, posters, newsletters, or other clinical and regulatory documents

• Interprets non-clinical and clinical data in the preparation of various technical reports

• Perform literature searches and reviews

• Leads project teams in drafting individual report specifications, medical writing, and coordination of data analysis

• Schedules and conducts peer and team quality control review for assigned projects

• Serves as primary functional representative on project teams

• Provides both in-house and outside consulting services

• Reviews all relevant documents and interacts with functional leader and project manager to develop a thorough understanding of project timelines

• Contributes to clinical protocol development

• Performs other tasks as directed by the line manager
  

Qualifications

• Experience in publishing/publications is preferred.

• A bachelor degree from an accredited institution in Life Sciences or Health-related Sciences, or equivalent

• Science or medical related writing experience required

• Familiarity with medical terminology

• Experience using computerized systems (PC-Windows and MS Word)

• Excellent written, oral communication and presentation skills

• Fluent in English reading, writing and speaking

• Pharmaceutical company or CRO experience developing pharmaceutical drugs for human use (e.g. pre-clinical science, medical related writing, clinical trials management, monitoring, or as an investigator or study coordinator for clinical trials)

• Experience in clinical study design and protocol development/writing

• Knowledge of regulatory submissions requirements, ICH clinical study report writing guidelines

上班地址：海淀区海淀西大街36号昊海楼8楼