Senior Regulatory Documentation Specialist

Nutanix; Bogotá; Híbrido; COP 221.758.000 - 348.476.000; Jornada completa

Descripción de la vacante

Bristol Myers Squibb is seeking a Senior Documentation Specialist to independently manage eDMS processes, publish regulatory documents, and collaborate with GSRD and external authors. The role involves mentoring, ensuring submission-ready formatting, and coordinating protocol and CSR documents across teams.

With a BS/BA and 2-4 years in regulatory documentation, you will use Acrobat/ISI toolbox and a document management system to uphold eCTD standards while driving timelines and quality.

Formación

• Minimum of BS/BA degree with approximately 2-4 years of regulatory documentation experience in document management repositories, submission readiness formatting and publishing workflows.
• 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 workflows.
• 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.

Responsabilidades

• 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 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.

Conocimientos

Regulatory documentation

eCTD formatting

eDMS

Acrobat

ISI toolbox

Document management system

Organizational skills

Interpersonal skills

Educación

BS/BA degree

Herramientas

Acrobat

ISI toolbox

eDMS

Descripción del empleo

Bristol Myers Squibb is seeking a Senior Documentation Specialist to independently manage eDMS processes, publish regulatory documents, and collaborate with GSRD and external authors. The role involves mentoring, ensuring submission-ready formatting, and coordinating protocol and CSR documents across teams.

With a BS/BA and 2-4 years in regulatory documentation, you will use Acrobat/ISI toolbox and a document management system to uphold eCTD standards while driving timelines and quality.