RWE Process Lead

Location: Anderlecht, Brussels (hybrid working model)

Engagement Status: Consulting Opportunity

Overview

MSI Pharma is partnered with a general pharmaceutical company to recruit an experienced RWE Process Lead. This role will be responsible for driving consistency, compliance, and continuous improvement across processes supporting Real-World Evidence (RWE) studies.

Working closely with cross-functional stakeholders, you will lead the review and enhancement of RWE processes, SOPs, templates, and training materials, ensuring alignment with evolving regulatory guidance and industry best practices. You will act as a subject matter expert (SME) for RWE processes, supporting study teams, quality initiatives, audits, and process implementation activities across the organization.

Requirements

- Lead the review, maintenance, and continuous improvement of RWE SOPs and process documentation.
- Partner with cross-functional stakeholders to ensure consistent and compliant RWE processes.
- Conduct gap analyses and help implement process changes driven by regulatory or business needs.




- Provide process guidance and support to RWE study teams and business stakeholders.
- Support audits, CAPAs, quality initiatives, training, and process implementation activities.

Hard Skills

- Strong experience in Real-World Evidence (RWE) and non-interventional studies.
- Knowledge of SOP management, process governance, and regulatory compliance.
- Experience supporting audits, CAPAs, and quality management activities.

Soft Skills

- Excellent communication and stakeholder management skills.
- Strong organisational skills with exceptional attention to detail.
- Ability to work independently while collaborating across teams.

Qualifications

- Master's degree in a scientific or related discipline.
- 5+ years of experience leading non-interventional or RWE studies within the pharmaceutical industry.
- Experience working in a regulated environment with exposure to process improvement and quality initiatives.

📌 Rwe lead (España)
🏢 MSI Pharma
📍 España