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Regulatory Intelligence Expert

hace 2 meses

Alcobendas, Madrid, España Parexel A tiempo completo
About the Role

Parexel is seeking a highly motivated and detail-oriented Quality Specialist (Regulatory Intelligence Specialist) to join our team.

As a Quality Specialist, you will be responsible for Regulatory Intelligence activities, ensuring that Parexel stays up to date with regulatory updates and implements relevant requirements.

Key Responsibilities:
  1. Regulatory Intelligence Activities: Lead and coordinate all Regulatory Intelligence activities, including research on regulatory updates, communication to stakeholders, and tracking the impact and implementation actions.
  2. Regulatory Intelligence Consultancy: Act as the point person for regulatory intelligence related consultancy.
  3. Quality Management System (QMS) Support: Assist the Parexel Quality group in the preparation for and follow-up of internal/external audits and inspections, as needed and relevant to Regulatory Intelligence Activities.
  4. Regulatory Intelligence SharePoint and Filing: Maintain the Regulatory Intelligence SharePoint and filing areas.
  5. Technical Knowledge: Provide technical knowledge where appropriate.
  6. Quality Process Development: Collaborate with Parexel Quality to develop and update quality/process documents, tools, and templates in line with regulatory intelligence activities.
  7. Metrics Generation: Generate metrics on Regulatory Intelligence Activities.
  8. Senior Management Reporting: Contribute to the metrics provided to Senior Management.
  9. Key Performance Indicators (KPIs): Complete assigned goals for key QMS elements, with a special focus on Knowledge Management/Regulatory intelligence activities and oversight.
  10. Additional Responsibilities: Undertake other duties as assigned.
Requirements
  1. Educational Background: Educated to degree level (technology, biological science, pharmacy, or other health-related discipline preferred) or equivalent qualification or clinical research experience.
  2. Experience: Experience in Quality Assurance, Quality Management, Regulatory Affairs, Clinical Research, Monitoring, Data Management, Pharmacy, Laboratory, or other relevant areas.
  3. Regulatory Affairs Knowledge: Good understanding of regulatory affairs landscape.
  4. Clinical Trials Experience: Experience working with clinical trials.
  5. Project Management: Project management capabilities applicable to Regulatory Intelligence activities and oversight.
  6. Communication Skills: Excellent interpersonal, verbal, and written communication skills, including the ability to present at meetings and training sessions.
  7. Corporate Procedures: Ability to rapidly learn, understand, and apply applicable corporate procedures.
  8. Time Management: Excellent time management skills, with the ability to prioritize workload and manage multiple tasks/projects with enthusiasm.
  9. Leadership: Ability to lead projects and teams.
  10. Data Analysis: Strong ability to analyze and interpret data.
  11. Attention to Detail: Attention to detail and advanced organizational skills.
  12. IT Literacy: IT literate, with a strong ability to work with Microsoft-based applications and relevant Regulatory Intelligence applications such as Cortellis or Tarius.
  13. Language Skills: Proficiency in written and oral English.