Global Regulatory Documentation Lead

Biopharma Careers; Bogotá; Híbrido; COP 378.334.000 - 472.918.000; Jornada completa

Descripción de la vacante

Bristol Myers Squibb is seeking a lead End-to-End Documentation Specialist to steer regulatory filings and HA responses. You will guide GSRD and external authors on eDMS, model documents, and submission-ready formatting for protocol and submission documents, ensuring timely, compliant deliverables across multiple submission types.

The role requires a BS/BA with 4+ years in regulatory documentation, strong Acrobat and ISI Toolbox expertise, and proven ability to train teams and manage timelines

Formación

• BS/BA degree and 4+ years in regulatory documentation
• Expertise in desktop applications and model documents for eCTD
• Strong Acrobat and ISI toolbox skills for PDF compilation and remediation
• Deep knowledge of global regulatory document publishing processes

Responsabilidades

• Lead and direct GSRD and external authors for eDMS and document publishing
• Oversee submission-readiness formatting for protocol and submission documents
• Provide strategic direction on documentation workstreams for HA submissions
• Coordinate training across GSRD and troubleshoot eDMS issues
• Define submission-ready requirements with cross-functional partners
• Manage collection and review of ICH appendices and related documents

Conocimientos

eDMS expertise

eCTD formatting

Acrobat & ISI toolbox

Document publishing

Training & troubleshooting

Educación

BS/BA degree

Herramientas

Acrobat

ISI toolbox

Descripción del empleo

Bristol Myers Squibb is seeking a lead End-to-End Documentation Specialist to steer regulatory filings and HA responses. You will guide GSRD and external authors on eDMS, model documents, and submission-ready formatting for protocol and submission documents, ensuring timely, compliant deliverables across multiple submission types.

The role requires a BS/BA with 4+ years in regulatory documentation, strong Acrobat and ISI Toolbox expertise, and proven ability to train teams and manage timelines