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
