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Yimo Liu

Yimo Liu

Report Writer and Data Reviewer

Healthcare

Vaughan, Ontario

Social

About Yimo Liu:

• Driven healthcare professional with 5 years of combined experience in regulatory writing / reviewing and quality compliance in clinical research and pharmaceutical industry, currently seeking regulatory affairs / reviewing and medical / technical writing opportunities.
• Certificate in Pharmaceutical Regulatory Affairs & Quality Operations Program from Seneca College.
• In-depth knowledge in clinical trial development, regulatory CMC, FDA and Health Canada regulatory submissions (CTA/IND, NDA/NDS, ANDA/ANDS, DINA, DEL, Clarifax etc.), Food and Drug / Medical Device Regulations, and industrial guidelines (GCP, cGMP, GLP, GDP, ICH, ISO etc.). • Skilled in project management and literature / document review. Adept in problem-solving, multitasking and managing priorities. Fast learner with excellent verbal and written communication skills.

Experience

• Driven healthcare professional with 5 years of combined experience in regulatory writing / reviewing and quality compliance in clinical research and pharmaceutical industry, currently seeking regulatory affairs / reviewing and medical / technical writing opportunities.
• Certificate in Pharmaceutical Regulatory Affairs & Quality Operations Program from Seneca College.
• In-depth knowledge in clinical trial development, regulatory CMC, FDA and Health Canada regulatory submissions (CTA/IND, NDA/NDS, ANDA/ANDS, DINA, DEL, Clarifax etc.), Food and Drug / Medical Device Regulations, and industrial guidelines (GCP, cGMP, GLP, GDP, ICH, ISO etc.). • Skilled in project management and literature / document review. Adept in problem-solving, multitasking and managing priorities. Fast learner with excellent verbal and written communication skills.

Education

York University

Seneca College

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