Experience

YICHANG HUMANWELL PHARMACEUTICAL CO.,LTD

• China
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Medical Affairs Specialist

  • Jun 2016 - Present

  1. Project Management of bioequivalence study between different CRO and different project. 2. Clinical trial license management 3. Understanding and knowing about the guidance of bioequivalence study in FDA and EU. 4. Protocol review. bioequivalence study report review 5. Monitor report review and check 1. Project Management of bioequivalence study between different CRO and different project. 2. Clinical trial license management 3. Understanding and knowing about the guidance of bioequivalence study in FDA and EU. 4. Protocol review. bioequivalence study report review 5. Monitor report review and check



普瑞盛医药科技开发有限公司

• 上海

• CTA

  • Jul 2015 - Nov 2015

  1. Understanding the principal of GCP and procedure of clinical trial 2. Submitting related document to IRB/IEC and get clinical trial approval opinion 3. Checking and verifying the investigational product, its quantity，storage condition and whether or not used for subjects. 4. Checking and Verifying the subject source data 5. Checking and confirm if all document provide signature and date 1. Understanding the principal of GCP and procedure of clinical trial 2. Submitting related document to IRB/IEC and get clinical trial approval opinion 3. Checking and verifying the investigational product, its quantity，storage condition and whether or not used for subjects. 4. Checking and Verifying the subject source data 5. Checking and confirm if all document provide signature and date