Senior Regulatory Documentation Specialist

Bristol Myers Squibb; Bogotá; Presencial; COP 216.497.000 - 309.282.000; Jornada completa

Descripción de la vacante

Bristol Myers Squibb seeks a Senior Documentation Specialist to independently manage eDMS processes, formatting, and publishing of regulatory documents. You will collaborate with GSRD and external authors, ensuring submission readiness across protocol and CSR content.

The role emphasizes meticulous document control, cross-functional coordination, and continuous improvement of regulatory workflows within a fast‑paced environment.

Formación

• BS/BA degree required or equivalent.
• Experience creating and formatting eCTD compliant regulatory documents.
• Proficient in Acrobat and ISI toolbox for document remediation.
• Familiar with document management systems for regulatory submissions.
• Ability to manage timelines and maintain high quality work.
• Strong troubleshooting and collaboration skills.

Responsabilidades

• Independently partner with GSRD and external authors to manage eDMS processes and publish submission documents.
• Mentor and assist GSRD personnel and external authors in eDMS and submission readiness formatting.
• Collaborate with cross-functional partners on SRC formatting and submission documents.
• Define submission-ready requirements for externally authored regulatory documents and remediate accordingly.
• Coordinate collection and review of ICH non-data driven appendices for CSRs.
• Contribute to GSRD model document updates and system approval processes.
• Author/select protocol and submission document types ensuring scientific and regulatory input integration.

Conocimientos

Regulatory docs

eCTD formatting

Documentation tools

Cross-functional work

Troubleshooting

Educación

BS/BA degree

Herramientas

Acrobat

ISI toolbox

eDMS systems

Descripción del empleo

Bristol Myers Squibb seeks a Senior Documentation Specialist to independently manage eDMS processes, formatting, and publishing of regulatory documents. You will collaborate with GSRD and external authors, ensuring submission readiness across protocol and CSR content.

The role emphasizes meticulous document control, cross-functional coordination, and continuous improvement of regulatory workflows within a fast‑paced environment.