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Technical Writer(QC Compliance,海归优先)

面议

无锡

|

经验不限

|

硕士及以上

职位诱惑:绩效奖金,带薪年假,交通补助,午餐补助,定期体检,免费班车,技能培训,五险一金
应聘职位

无锡药明生物技术股份有限公司

制药/生物工程  | 1000-2000人

无锡滨湖区梅梁路108号查看地图

职位描述

Job Summary: This is a full-time position to write and review departmental SOPs, protocols, reports, and CMC regulatory documents. The Technical Writer is responsible for:

Essential Job Functions:
• Work in collaboration with technical and functional area SMEs to generate and review SOPs, protocols, and reports
• Analyze documents for accuracy, usability, clarity, flow, and identifying opportunities for improvement
• Manage and support document development and maintenance for multiple documents simultaneously
• Work in a team environment and independently as required
• Understand and apply ICH, FDA, EMA, ChP, and other relevant regulatory and guidance documents to daily work
• Some evening or weekend work may be required
• Contributes to the overall operations and to the achievement of departmental goals
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
• Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices


Experience / Education
• A minimum of 2 years of relevant experience or equivalent
• A minimum of a Bachelor’s degree is required, preferably in life or physical sciences
• Previous experience in the Pharmaceutical or Biotechnology industry is preferred

Knowledge / Skills / Abilities:
• Proficient in Oral & Written communication skills (English and Mandarin)
• Need to be able to read, write and understand English and Mandarin
• Must have expertise in translating documents from Mandarin to English and English to Mandarin. A writing sample will be required prior to interview.
• Proficient in Microsoft (Excel, Word, Outlook)

岗位要求

  • 不限
  • 英语 + 普通话
  • QC
  • 0人

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