Global Regulatory Documentation Leader

Nutanix; Bogotá; Híbrido; COP 380.156.000 - 506.874.000; Jornada completa

Descripción de la vacante

Bristol Myers Squibb is seeking a regulatory documentation lead to drive end-to-end workstreams for submissions and eDMS processes. You will coordinate internal teams and external authors, ensuring submission readiness across HA activities and complex protocol documents.

This role emphasizes accuracy, collaboration, and timely delivery with a focus on continuous improvement in publishing regulatory documents for global filings.

Formación

• BS/BA degree with 4+ years of regulatory documentation experience.
• Subject matter expertise in eCTD and submission readiness formatting.
• Proficiency in Acrobat and ISI toolbox for complex PDF work.

Responsabilidades

• Lead end-to-end documentation workstreams for regulatory filings and HA responses.
• Coordinate GSRD and external authors for eDMS and document publishing.
• Oversee submission-ready documents including model 2 summaries and HA submissions.
• Provide training across GSRD and troubleshoot eDMS, templates and publishing workflows.
• Advise cross-functional partners on formatting and publishing requirements.
• Direct submission readiness remediation and publishing of externally authored files.
• Coordinate, compile and author protocol and submission document types.
• Contribute to continuous improvement of regulatory documentation processes.

Conocimientos

Regulatory documentation

eCTD submission

eDMS processes

PDF publishing

Cross-functional leadership

Educación

BS/BA degree

Herramientas

Acrobat

ISI toolbox

Document management system

Descripción del empleo

Bristol Myers Squibb is seeking a regulatory documentation lead to drive end-to-end workstreams for submissions and eDMS processes. You will coordinate internal teams and external authors, ensuring submission readiness across HA activities and complex protocol documents.

This role emphasizes accuracy, collaboration, and timely delivery with a focus on continuous improvement in publishing regulatory documents for global filings.