Medical Writer

Major Responsibilities：

• As a member of China Project Team, following the timeline to prepare high quality clinical study reports, narratives, literature review, abstracts, posters and slide sets support  regulatory submissions and meetings with HAs or MEs as needed
• Participate in planning of analysis, investigators meetings and data presentation to be used in study report.
• May act as documentation consultant in clinical trial teams to ensure compliance of documentation to internal company standards and external regulatory guidelines.
• Perform quality control (QC) checking/proof reading of the documents.
• Assist in outsourcing to external medical writers.
• Maintains records for all assigned projects including archiving.
• Compliance with Novartis standards, policies and applicable regulations

Requirement：

• Minimum university life science degree or relevant equivalent background with 4 years clinical research experience.
• Chinese fluent, writing skills to scientific writing standards, good written and oral English skills
• Strong scientific/clinical knowledge of oncology and hematology.
• Good in data interpretation
• Understand of statistics
• Good document creation and editing skills
• Expertise in writing synopses, abstracts, literature reveiws, posters and clinical study reports.
• Familiar with IT applications, office productivity skills and document formatting skills
• Result driven team player, excellent communication skills