Senior Scientific Writer I (Senior manager level)

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 . Bristol Myers Squibb es un empleador que brinda igualdad de oportunidades. Las personas que apliquen para cualquier vacante, y que estén calificadas para la misma recibirán consideración para el empleo sin distinción de raza, color, religión, sexo, orientación sexual, identidad de género, nacionalidad, edad, discapacidad, condición de veterano protegido, embarazo, ciudadanía, estado civil, expresión de género, información genética, afiliación política o cualquier otra característica protegida por la ley. Leads document strategy and authoring of message-driven, clear and concise regulatory documents in support of submissions and approvals in key markets and other geographies. Provides support for fit-for-purpose regulatory documents (clinical pharmacology, clinical, safety) to facilitate speed of information during development, submission, approval, and life cycle management of products in BMS pipeline. Objective: To coordinate and author documents needed for regulatory submissions, ensuring the coordination and integration of the scientific, medical, and regulatory input from cross-functional team members Duties/Responsibilities ·       Authors complex clinical documents [eg, Investigator's Brochures (IB), Protocols, Phase 2/3 Clinical Study Reports (CSR), briefing documents, Common Technical Document (CTD) summary documents, responses to Health Authority queries] for timely submission to health authorities worldwide according to: o   good documentation principles (organization, clarity, scientific standards) o   consistency between text and tabular presentations or graphical displays o   in compliance with BMS documentation standards and worldwide regulatory requirements ·       Use document development tools that incorporate artificial intelligence, structured content, programming features, and other evolving approaches to enhance efficiency, quality, and speed of processes. ·       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. ·       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: o   optimal communication between authoring team and development team members o   coordination and efficient use of messages between internal development plans, IND and Marketing Authorization documentation o   timely completion and high quality of assigned documents ·       Review and edit documents as required. ·       Serves as a liaison for external documentation support (when required), prepares specifications for the work, and ensures maintenance of good documentation principles as well as BMS documentation standards. ·       Leads and influences a diverse group of authors of regulatory documents from a variety of disciplines without a reporting relationship. Qualifications PharmD/PhD in a relevant scientific discipline or Master's/Bachelor's degree with approximately 5 years of pharmaceutical regulatory documentation. All PhD in biological sciences and PharmD candidates are considered. Demonstrated strong writing skills in authoring and managing the production of IB, Safety Aggregate Report, Clinical Protocols, and/or CSR. Demonstrated ability to analyze and interpret complex data from a broad range of scientific disciplines. Good understanding of global pharmaceutical drug development and requirements for documentation authoring supporting regulatory submissions. Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team. Working knowledge of a document management system and basic knowledge of the document publishing process. #LI-Hybrid 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 incl