• Manage clinical development of current cases including clinical trial initiations, execution, monitoring, CRA coaching, and proactively fulfil timelines within budget.
• Ensure clinical studies following ICH/GCP compliance.
• Conduct CRO management including vendor selection, contract negotiation, supervision of daily operations.
• Implement periodical QC review of TMF.

• Offering clinical support services such as biopsy workshops and training, consultation and troubleshooting for pre-implantation testing, endometrial testing, and research assistance to aid customers.
• Providing sales support through various platforms including product and sales presentations, seminars, webinars, and conferences.
• Delivering marketing support by offering guidance on promotional materials and related activities.

• Serve as as a key medical point for the brand team
  • Act as the main medical contact for the brand team, offering clinical and strategic insights.
  •  Plan and implement relevant customer meetings such as speaker training, advisory boards, scientific exchanges, and educational events.
• Scientific Expertise and Medical Affairs Delivery
  • Aid in data analysis and preparation of slide sets and publication
  • Contribute to Scientific Data Disclosure plans.
  • Act as the affiliate medical leader, handling research and regulatory tasks.
• Customer Support & Experience
  • Address external customer inquiries, including escalations from Medical Information and sales, following protocols for unsolicited information requests.
  • Provide scientific, educational, and promotional presentations both internally and to customers

Key Medical Contact for Brand Team:

• Provide clinical, scientific, and strategic insights to support cross-functional teams.
• Contribute to local brand plans and medical strategies.
• Communicate therapeutic knowledge effectively to the brand team.
• Plan and implement customer meetings such as speaker training, advisory boards, scientific exchanges, and educational events.

Scientific Expertise and Medical Affairs Delivery:

• Develop medical plans and strategies for the affiliate or therapeutic area.
• Aid in data analysis and preparation of publications.
• Act as the medical/scientific leader for research and regulatory tasks.
• .Monitor trends and projections in clinical practice and access.

Customer Support & Experience:

• Develop and maintain relationships with professional societies.
• Provide scientific, educational, and promotio

1. 規劃生產工程發展策略與部內人力運用、工作分配與組織。

2. 甄選、發展人力並安排工作與部內指標建立及監控。

3. 領導團隊、工作與人員指揮、激勵工作士氣。

4. 追蹤並控制資源運用、工作進度、效率與品質。

5. 推動與執行部門內/跨部門溝通協調整合。

6. 分析與解決製程問題，以及評估並選擇設備等相關決策。

1.審核QC報告(檢驗、確效、校正)。

2.制定QC相關文件。

3.化驗室人員、設備與進度管理

4.品質異常、客訴調查處理與矯正措施追蹤管理。

5.其他主管交辦事項。

1.督導及查核藥廠GMP執行成效

2.提升公司品質系統管控功能