You will design, maintain, and drive the adoption of SCM standards—component definitions, metadata schemas, taxonomy, lifecycle governance, and content quality frameworks—across R&D.;

Ensures all SCM artefacts are audit-ready, compliant with regulatory requirements, and fit for automated downstream consumption, including AI-assisted and generative authoring workflows as these scale across R&D.;

Lead the SCM Horizontal governance operations, and provide a strong contribution to the vendor engagement and change management/adoption workstreams, in support of the Business Lead, SCM Horizontal.

Define, document, and maintain SCM component standards: component taxonomy, metadata schemas, semantic conventions, versioning rules, and lifecycle governance (authoring through review, approval, reuse, and retirement) in collaboration with functional governance across R&D.;

Operate the component registry: intake validation, provenance tracking, reuse permissions, change control, and audit trail management.

Conduct standards compliance monitoring: assess adoption, identify deviations, produce compliance reports, and work with vertical teams to remediate gaps.

Ensure alignment with external regulatory and clinical content standards (CDISC, SNOMED, MedDRA, HL7 FHIR, ICH eCTD, TransCelerate SDR) and internal GxP requirements.

Partner with Medical Writing, Regulatory, Quality, and Data Governance SMEs to validate and evolve standards in line with evolving programme and regulatory requirements.

Build and deliver training and guidance materials for SCM standards across author, reviewer, and technical communities.

Requirements

Bachelor's degree in Information Science, Regulatory Affairs, Life Sciences, Medical Writing, or a related field.

Advanced degree or relevant professional qualification preferred.

Substantive experience in content governance, standards management,



or regulatory operations in a regulated pharmaceutical or life sciences environment.

Practical knowledge of structured content, component-based authoring, DITA, or equivalent content modelling approaches.

Familiarity with GxP requirements and audit-ready documentation practices.

Experience working with regulatory content standards (CDISC, ICH, MedDRA, SNOMED, or similar) is strongly preferred.

Background in medical writing, regulatory submissions, or clinical operations is a strong advantage.

Experience developing training materials and supporting adoption of new standards or processes.

Experience leading enterprise-scale content transformation or digital authoring programmes—including structured/component content platforms, reuse strategies, and AI-enabled or generative authoring pilots—in a regulated life sciences environment is a strong advantage.

Core Competencies
Demonstrates expertise in SCM standards design and governance, ensuring compliance with regulatory requirements and alignment with external content standards. Proficient in developing training materials and leading content transformation initiatives in a regulated life sciences setting.

Highest-signal resume keywords

SCM Standards Management

Regulatory Compliance

Content Governance

Structured Content Authoring

Training Development

ATS Optimization Keywords
Hard Skills

Content Governance

Standards Management

Component-Based Authoring

DITA

Audit-Ready Documentation

Regulatory Content Standards

GxP RequirementsContent Transformation

AI-Enabled Authoring

Change Management

Soft Skills

Collaboration

Leadership

Communication

Training

Vendor Engagement

Certifications & Qualifications

Bachelor's Degree in Information Science

Advanced Degree in Related Field

Industry Keywords

Pharmaceutical

Life Sciences

Clinical Operations

Medical Writing

Regulatory Affairs

CDISC

SNOMED

MedDRA

ICH eCTD

TransCelerate SDR

#J-18808-Ljbffr

📌 Senior Director, Structured Component Management Strategy, Operations & Governance (Ontario)
🏢 Jobtailor
📍 Ontario