Senior Documentation Specialist

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. Independently manage eDMS processes within scope, submission-readiness formatting, and publishing of regulatory documents including clinical study reports, Investigator Brochures, safety aggregate reports, module 2 summaries and clinical protocol documents. Duties/Responsibilities ·       Independently partner with GSRD and external authors for management of eDMS processes within scope and document publishing of protocol and submission documents. ·       Mentor, train and provide troubleshooting assistance to GSRD personnel and external authors in the eDMS, Core Template, submission readiness formatting and publishing work processes. ·       Collaborate with cross-function business partners providing direction in SRC formatting and publishing of protocol and submission related documents ·       Lead cross functional business partners in defining submission-ready requirements for externally authored regulatory documents.  Independently manage submission readiness remediation, eDMS import and publishing of externally authored PDF files.  ·       Independently manage collection and review of ICH non-data driven appendices for CSRs. Direct cross functional business partners (CTAs, Protocol Managers) in defining submission-ready requirements for ICH non-data driven appendices.  ·       Contribute to GSRD model document updates and system approval processes. Independently coordinate, compile and/or author select protocol and submission documents types ensuring integration of scientific and regulatory input from team members. Participate in continuous improvement workstreams to enhance quality and increase efficiency of document processes, including automated and digital solutions for development of regulatory documentation.

Minimum of BS/BA degree with approximately 2-4 years of regulatory documentation experience in document management repositories, submission readiness formatting and publishing work flows. In-depth understanding of desktop applications, word template macros, model documents and submission readiness formatting for creation of eCTD compliant regulatory documents. In-depth understanding of Acrobat and ISI toolbox usage in creation and remediation of eCTD compliant regulatory documents. In-depth understanding of a document management system for assembly and management of regulatory documents. Understanding of document publishing processes across document types Demonstrated troubleshooting skills in eDMS, submission readiness formatting and