A pharmaceutical company is looking for a Process Lead for Real World Evidence (RWE). This position is ideal for you if you come from clinical or observational studies, but your true passion lies in process management, compliance, and continuous improvement. This is a role focused on process management and stakeholder relations, not a highly technical scientific or methodological position.
Your main mission will be to ensure the consistency and compliance of the company's processes related to conducting RWE studies.
What you will do. In a context of high activity, you will help the team manage three major projects:
- Lead the review, update, and harmonization of standard operating procedures (SOPs) related to RWE, ensuring their compliance with international guidelines.
- Participate in remediation actions following audits and support deviation processes and corrective/preventive actions (CAPA).
- Participate in user acceptance testing (UAT) and the validation of a new digital platform dedicated to the management of RWE studies and documents.
- Act as a Subject Matter Expert (SME) and collaborate closely with multiple departments (Quality Assurance, Pharmacovigilance, Medical Affairs, etc.) to align processes.
Profile
To excel and be quickly operational in this role, you must absolutely possess:
- A Master's degree.
- Solid experience (more than 5 years) in project management for end-to-end non-interventional / RWE studies within the industry.
- Practical mastery of the RWE domain, including concrete experience in managing studies on the use of secondary data (SDU / databases).
- Confirmed experience in managing SOPs and regulated processes (ideally with a strong interest in procedural work).
- Excellent communication and stakeholder management skills, with the ability to synthesize information and lead cross-functional discussions.
- Fluent English, essential to work in this international team.
Additional assets.
- Proficiency in French.
- Experience in quality assurance/audit.
- Experience with platforms such as Salesforce.
How to apply
View the full assignment text and application details once your tailored application is ready.
Order a tailored application to view the full assignment and application details.
More context, less searching.
You get enough context to judge whether this job is relevant. The full brief, client details and next steps stay available inside the app.