RWE Process Consultant

R&D Partners; Brussel; Hybride; EUR 60 000 - 90 000; Plein temps

Résumé du poste

R&D Partners in Belgium is seeking an RWE Process Consultant to support a global pharmaceutical company. The role focuses on process management, SOP updates, compliance, and cross-functional collaboration within the Real World Evidence Centre of Excellence.

Hybrid work is available with 2-3 days in the office; candidates must have the right to work in Belgium. You will review SOPs, manage audits, and coordinate with QA, Pharmacovigilance, Clinical Development, Medical Affairs, and Market Access

Qualifications

• Strong understanding of Real World Evidence (RWE).
• Experience with SOPs and regulated processes.
• Excellent stakeholder management and communication.

Responsabilités

• Review, update, and harmonize RWE SOPs.
• Address audit findings and ensure process compliance.
• Collaborate with QA, Pharmacovigilance, Clinical Development, Medical Affairs, and Market Access.
• Participate in User Acceptance Testing for a new digital platform.
• Coordinate with multiple departments to drive process alignment and audit actions.

Connaissances

Real World Evidence

RWE studies

SOPs compliance

Stakeholder management

Attention to detail

Outils

Salesforce

Description du poste

Join a high-impact RWE Centre of Excellence and play a key role in driving compliance, process improvement, and operational excellence across global teams.

R&D Partners is seeking an RWE Process Consultant to support a global pharmaceutical company during a critical period of increased workload. This role focuses on process management, SOP updates, compliance, and cross-functional collaboration within the Real World Evidence (RWE) Centre of Excellence.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

Process Management & Continuous Improvement:

• Review, update, and harmonize RWE SOPs.
• Address audit findings and ensure compliance across processes.
• Support quality and compliance-related initiatives.

Cross-Functional Collaboration:

• Work closely with stakeholders across Quality Assurance, Pharmacovigilance, Clinical Development, Medical Affairs, and Market Access teams.
• Facilitate discussions and drive process alignment activities.

Digital Platform Support:

• Participate in User Acceptance Testing (UAT) for a new digital platform managing RWE studies.
• Verify workflows, milestones, and document structures.
• Ensure alignment between business processes and the digital solution.

Typical Day:

• Reviewing and updating SOPs and procedural documentation.
• Attending meetings with QA teams, process owners, and other stakeholders.
• Coordinating with multiple departments to drive process alignment.
• Supporting audit-related actions and compliance initiatives.
• Participating in testing and validation activities for the new digital platform.

Key Skills and Requirements:

Must-Have Skills:

• Strong understanding of Real World Evidence (RWE).
• Familiarity with RWE studies, observational studies, or non-interventional studies.
• Experience working with SOPs and regulated processes.
• Excellent stakeholder management and communication skills.
• Well-organized, detail-oriented, and process-driven.

Nice-to-Have Skills:

• Pharmaceutical industry experience.
• Exposure to quality, compliance, or audit-related activities.
• Experience in Integrated Evidence Generation or Evidence Generation Planning.
• Experience with UAT activities and/or Salesforce-based platforms.
• RWE Project Managers or professionals involved in Real World Evidence programs.
• Candidates from CROs (e.g., IQVIA) or those managing observational/non-interventional studies.
• Life science professionals with experience in evidence generation activities.

Working Model:

• Hybrid: Preferred office presence 2-3 days per week.
• Exceptional candidates with lower office attendance may still be considered.