Senior Documentation Specialist

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.

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.

Qualifications

• 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 document publishing work flows.

• Ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills

• Effective interpersonal skills to work well in a matrix team environment and with colleagues at all levels in the organization

#LI-Hybrid

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only:  If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.com with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1604433 : Senior Documentation Specialist