Regulatory Affairs Project Lead

hace 1 mes

Alcobendas, Madrid, España Parexel A tiempo completo
Senior Regulatory Affairs Consultant (Project Lead)

We are seeking a highly experienced Senior Regulatory Affairs Consultant to lead internal projects on behalf of our clients. As a Senior Consultant, you will be responsible for providing a broad range of consulting services and working within project guidelines to identify, refine, and address client issues and achieve project objectives.

Key Responsibilities:
  • Project Initiation Management:
    • Own the client relationship and responsibility for client communication ensuring high client satisfaction
    • Cooperate 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
    • Pro-active approach to providing solution sets for clients
  • Project Execution Management:
    • Lead client kick-off meeting and discussions with client, establishing client expectations for project delivery, communication, and client-specific metrics. Ensure the scope of the project is well understood by the project team and set the team expectations
  • Project Implementation, Control & Evaluation:
    • 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 fulfill 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
  • Project Closure Management:
    • Oversee all administrative closeout procedures are completed, according to Project Closeout Checklist
    • Review the project contract exhibit and ensure relevant team members have received it
    • 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
    • Review initial budget request with SC/CXD for any project-specific adaptations
    • Participate in or manage the team kick-off meeting
    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
    • CRO experience
    • Experience in MAA preparation and submissions
    • Project management knowledge and experience
    • Financial management skills
    • Excellent interpersonal and intercultural communication skills, both written and verbal
    • Fluent in English

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