Key accountabilities:
? Leads the Medical Writing effort for local requirements in a global, priority program
? Independently leads the MW deliverables for complex global programs
? Acts as the Lead Writer/oversight for clinical sections of eCTDs for Chinese market approval
? Oversees work of internal and/or external writers (consultants, contractors and vendors, depending on operating model) 
? Attends governance meetings e.g. for protocols
? No direct people management
Profile requirements 
? Minimum requirement of a bachelor’s degree in a scientific or writing discipline; Master’s degree or Ph.D. preferred. 
? Minimum of 5-8 years related experience in a medical or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge 
? Fluent in English (oral and written). 
? Ability to lead discussions on document strategy and alignment across a program 
? Strong CTD knowledge and experience in generating clinical CTD documents  
? Strong communication skills (verbal, written, and listening) with the ability to interpret and summarize complex data 
? Excellent time and priority management; ability to work efficiently under pressure