Senior Scientific Writer I

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. * Author complex clinical documents needed for Clinical Study Reports (CSR), briefing documents, Common Technical Document (CTD) summary documents, responses to Health Authority queries) for timely submission to China health authorities according to: * good documentation principles (organization, clarity, scientific standards) * consistency between text and tabular presentations or graphical displays * in compliance with BMS documentation standards and worldwide regulatory requirements * Participate in relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents. * Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects. * Participate in document prototyping sessions, including document flow, logic, and consistency for assigned project prototypes, and maintain document prototypes and shells. * Associate global regulatory submissions Protocols, Phase 1/2/3 and Investigator's Brochures (IB). * Comply with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure: * optimal communication between authoring team and development team members * coordination and efficient use of messages between internal development plans, IND and Marketing Authorization documentation * timely completion and high quality of assigned documents * Review and edit documents as required. * Serve as a liaison for external documentation support (when required), prepare specifications for the work, and ensure maintenance of good documentation principles as well as BMS documentation standards. * Lead and influence a diverse group of authors of regulatory documents from a variety of disciplines without a reporting relationship. * Be bold in exploring innovative approaches and methods for medical writing. If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of...