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