Medical Writing Lead

The Lead, Medical Writing in collaboration with global medical writing team and China CPT is responsible for the creation of medical writing deliverables for China, ensuring the high-quality, timely, and efficient development of clinical and regulatory documents that comply with internal and external standards. The Lead, Medical Writing will be the lead author of regulatory and other scientific documentation, manage the overall collection of content from cross functional teams to produce documents according to ICH guidelines, company SOPs, and applicable local regulations and guidelines; be involved in strategic regulatory discussion during entire drug development process collaborating with China Reg Leads and/or CPT; be the primary Medical Writing point of contact for China with global medical writing function & manage the work and deliverables of China-based contract/vendor MW as needed

• Master’s degree in life science discipline (Ph D preferred) • 7-10 years’ experience of medical writing in global drug development including submission/approval and launch of new products • Excellent verbal and written English written and communication skills • Exceptional organizational skills and attention to detail • Project management skills and familiarity with GCP and ICH guidelines. • Technical skills with relevant software for authoring • The ability to remain flexible should priorities change (judgment and decision making) during project execution. • Able to work in multi-culture environment • The ability to influence cross-functionally to improve procedures or practice as needed to remain within regulatory compliance and promote internal quality and efficiency • Able to mentor and manage work of vendors or junior writers as needed

职位描述

职位要求