Parexel
10,000+ employees
Founded 1983
⚕️ Healthcare Insurance
🧬 Biotechnology
💊 Pharmaceuticals
💰 Venture Round on 1990-01
Healthcare Insurance • Biotechnology • Pharmaceuticals
Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.
Senior Regulatory Affairs Consultant – Project Lead
🕒 June 2
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Parexel
10,000+ employees
Founded 1983
⚕️ Healthcare Insurance
🧬 Biotechnology
💊 Pharmaceuticals
💰 Venture Round on 1990-01
Healthcare Insurance • Biotechnology • Pharmaceuticals
Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.
📋 Description
• Own the client relationship and responsibility for client communication ensuring high client satisfaction • Cooperates with the Finance Business Partner to ensure that any systems and system interfaces are functioning • Work with RAL and /or TL to provide initial schedule and resource plan to GRT • Lead client kick off meeting and discussions with client, establishing client expectations for project delivery, communication, and client specific metrics • Manage the project such that it is completed within budget, schedule and according to contract specifications • Ensure the project is progressing according to quality standards, SOPs, and to fulfil local regulations • Proactively take action where required to maintain project deliverables, to effectively manage the project’s critical path, resourcing, metrics compliance, the budget and third party vendors • Manage the project budget with the Finance Business Partner including the completion of monthly revenue recognition, forecasting and cost management • Oversee all administrative closeout procedures are completed, according to Project Closeout Checklist • Manage the set-up of the project team, oversee request for resources, review proposed team members for suitability and manage any project team changes throughout the duration of the project.
🎯 Requirements
• University Degree in a Scientific or Technical Discipline, Advanced Degree Preferred • PMP or equivalent - nice to have • Extensive years of Regulatory Affairs experience in an industry-related environment • Experience in MAA preparation and submissions • CRO experience • Project management knowledge and experience • Financial management skills • Excellent interpersonal and intercultural communication skills, both written and verbal • Fluent in English
🏖️ Benefits
• Health insurance • Paid time off • Professional development opportunities
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