Regulatory Affairs Project Lead MAAs

hace 2 semanas

Alcobendas, Madrid, España Parexel A tiempo completo

Unlock Your Potential in Regulatory Affairs

We are seeking a highly skilled and experienced Senior Regulatory Affairs Consultant (Project Lead) to join our team at Parexel. As a Senior Consultant, you will be responsible for leading internal projects on behalf of our clients, providing a broad range of consulting services and working within project guidelines to identify, refine, and address client issues and to achieve project objectives.

Key Responsibilities:

  • Project Initiation Management:
  • 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
  • Pro-active approach to providing solution set 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 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
  • 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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