Manager, Scientific Writing

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

• 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.

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R1606583 : Manager, Scientific Writing