Position Summary
 Lead the authoring of clinical/regulatory documents (protocol, briefing book, clinical study report, CTD 2.5, CTD 2.7.3&4) and support the performance goals (including quality and timeline) for filing regulatory dossiers in China as planned by the R&D Development Teams. In addition, make challenging proposals from the viewpoint of writing strategies and processes depending on the situation, and lead the team.

 Establish cross-divisional cooperative partnership with other functions and lead to more efficient process development, according to the optimized and standardized processes and systems.

 Fulfill the role of Manager, China Scientific Writing and support the less experienced writer
Position Responsibilities
 Input&review the storyboard to author regulatory dossier policies and align with global team based on the information provided by DT and make challenging proposals from the viewpoint of writing strategies according to the situation.

 As Manager, China Scientific Writing, understand the global authoring regulatory dossier strategy and lead the finalizing of domestic regulatory dossiers of clinical part.

 Set an appropriate and the shortest timeline to complete authoring regulatory dossiers and comply with the timeline. In addition, make challenging proposals from the viewpoint of the process depending on the situation and shorten the target timeline.

 Propose to the team the optimal strategy for preparing regulatory submission documents and lead the process improvement based on the tendencies of each review division concerning the contents of NMPA review reports and inquiries.

 Complete the clinical modules with cross functions based on the storyboard.

 Manages and provides global submission materials to stakeholders as needed.

 Authoring and conducting a coordinating activity as CSR author.

 Take charge of the CSR authoring part in the reliability survey.

 Manage the operational execution by strategically using outsource vendors and ensuring quality deliverables.

 Comply with internal and external processes and guidelines.

 Review and edit other clinical/regulatory documents as required.

 Drive continuous process improvements by identifying and simplifying processes. Lead cross-functional business process improvements based on information from collected metrics.

 As a senior scientific writer, give advice to other scientific writers to help them improve their capabilities in creation of clinical/regulatory documents for China. Also, provide guidance and support to the inexperienced writer.

 Provide additional value by creating better collaborative work environment internally and externally to ensure that China team has a good communication with HQ counterparts as well as key stakeholders, such as clinical research and regulatory.

 Good communication with Global Scientific and Regulatory Documentation (GSRD) leadership team to facilitate collaboration with GSRD in China submission.

 Give advice to members in our organization from the viewpoint of scientific writing even for irregular applications and types of applications /consultations that have not been experienced before

其他信息
语言要求：英语、普通话
行业要求：全部行业
所属部门：RegulatoryAffairs