Brabant Wallon – contracting Job description
* Documentation & Learning lifecycle management:
* Ensure the organization, maintenance and lifecycle management of controlled documents and training materials
* Ensure compliance with applicable regulatory frameworks (GLP, GCP, Research Guidance, HTA, HBS, HSE, etc.) and internal standards
* Process harmonization and continuous improvement
* Support the design and implementation of streamlined, harmonized processes that integrate documentation and learning activities
* Contribute to continuous improvement initiatives aimed at enhancing efficiency, simplification, compliance and user experience
* Promote best practices and innovative solutions in documentation and learning management, fostering a harmonized, customer-focused, and outcome-driven culture
* Regulated, non-Regulated & Controlled Document management
* Act as the coordinator for the Regulated/Non-Regulated/Controlled Document management system, ensuring timely tracking, updates, reviews, and approvals of SOPs, guidance and related documents (based on regulatory changes, SME inputs, inspection finding or scheduled reviews)
* Provide expert guidance to document owners and Patient Solutions staff on controlled document management best practices.
* Ensure effective training and communication related to new or revised SOPs & associated documents, including timely withdrawal of obsolete documents
* Training coordination
* Support Patient Solutions employees and managers in meeting training requirements by maintaining accurate training plans, curricula and matrices
* Ensure the availability and accessibility of training materials linked to controlled documents impacting Patient Solutions
* Collaborate with the department learning lead and line managers to develop and maintain relevant training programs (plans, matrices, …).
* Manage training records and documentation, including CVs, job descriptions, attendance logs, training registers, ….
* Stakeholder engagement and support:
* Serve as a key point of contact for all Learning & Documentation-related questions.
* Manage and respond to requests received, including through the global PSol Learning & Documentation mailbox.
* Audit & Inspection Readiness
* Ensure operational readiness for internal and external inspections and audits related to documentation and learning.
* Track and follow up on actions resulting from audit or inspection findings.
* Performance Monitoring & Reporting
* Collect, consolidate, and report key performance indicators and metrics related to documentation and training compliance.
* Maintain and update the Learning & Documentation compliance dashboard.
* Additional operational support
* Provide support as needed to the Head of Internal Coordination, Learning & Sustainability Compliance in managing and reporting on broader initiatives, including sustainability, compliance, communication, intranet content, PMO dashboards, and objective tracking
Profile
* Relevant experience in GxP (GLP, GCP) regulations and within the pharmaceutical industry
* Relevant experience in SOP /training and content management systems
* Familiar with electronic document management systems (e.g., Veeva, SharePoint, or similar platforms) and Learning Management Systems (LMS) for training assignment, tracking, and reporting.
* Languages skills: French and English
* Proficiency in Microsoft Office suite (Word, Excel, PowerPoint)
* Ability to collect, analyze, and develop visual reports, KPIs and compliance metrics.
* Experience in dashboard creation and, potentially, in the use of communication tools
* Detail-oriented with the ability to maintain a high-level perspective
* Strong organizational, planning and coordination skills, with the ability to prioritize tasks, manage multiple responsibilities, and proactively adapt in an evolving environment
* Ability to interact and collaborate with cross-functional teams and various stakeholders
* Analytical mind, ability to make improvement suggestions and resolving issues
* Project management and influencing skills
Offer Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
You’re interested in this job? We kindly invite you to apply.