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Job Descriptions

Regulatory Medical Writer, 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

• Writes and reviews clinical study reports and other clinical/regulatory documents
• Demonstrates technical expertise and background in the use of medical writing templates and software
• Writes clear and concise documents, including study reports, protocols, core data sheet, dossier summary documents, and other regulatory submission documents
• Drive the document preparation process, review primary statistical output, draft and distribute regulatory documents for review, and incorporate/resolve comments from all reviewers

Qualifications

• PhD in pharmacology or relevant areas required, open to entry level and newly graduated candidates
• Fluent in English and Chinese
• Excellent scientific/medical 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 regulatory guidelines applicable to submission documents
• Excellent interpersonal and oral communication skills
• Proficient in MS Word, Excel, PowerPoint, and Outlook
• Ability to prioritize multiple projects

Employment Type

Full-time