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Job Descriptions

Biostatistician, Level 1

Position Summary

CRC Oncology is looking for a Regulatory Medical Writer who researches, writes, and edits clinical and regulatory documents by applying functional expertise and clinical drug development knowledge. Writes clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documents. Exhibits excellent written and oral communication and presentation skills. Demonstrates technical expertise and background in the use of medical writing templates and software.

Responsibilities

• Manages all aspects of the medical writing function
• Writes and reviews clinical study reports, protocols, and other clinical/regulatory documents
• Contributes to clinical protocol development for first-in-human oncology studies
• Demonstrates technical expertise and background in the use of medical writing templates and software
• Writes clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documents
• Drive the document preparation process, receive, and review primary statistical output, draft and distribute documents for review, and incorporate/resolve comments with all reviewers
• Acts as a lead medical writer on complex programs and numerous individual studies

Qualifications

• PhD required, open to entry level and newly graduated candidates
• Fluent in English and Chinese
• Excellent writing skills
• Ability to understand and interpret clinical and scientific data; ability to present results in an understandable manner to a variety of audiences
• Knowledge of current requirements and guidelines applicable to submission documents
• Excellent interpersonal and oral communication skills
• Strong knowledge of MS Word, Excel, PowerPoint, and Outlook
• Ability to prioritize multiple projects

Employment Type

Full-time