RWE Process Consultant
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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
- Review, update, and harmonize RWE SOPs.
- Address audit findings and ensure compliance across processes.
- Support quality and compliance-related initiatives.
- Work closely with stakeholders across Quality Assurance, Pharmacovigilance, Clinical Development, Medical Affairs, and Market Access teams.
- Facilitate discussions and drive process alignment activities.
- 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.
- 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
- 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.
- Fluent in English.
- French language 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.
Relevant Backgrounds
- 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.
Salary
- €80 – €90
For more information, please contact James Inwood.