United Kingdom Job Openings

Parexel
Regulatory Intelligence Specialist
October 11, 2024
ABOUT THIS ROLE
Key Responsibilities:
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Lead and coordinate all Regulatory Intelligence activities, including research on regulatory updates, communication to stakeholders, and tracking the impact and implementation actions.
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Act as the point person for regulatory intelligence related consultancy.
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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.
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Maintain the Regulatory Intelligence Share Point and filing areas.
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Provide technical knowledge where appropriate.
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Collaborate with Parexel Quality to develop and update quality/process documents, tools, and templates in line with regulatory intelligence activities.
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Generate metrics on Regulatory Intelligence Activities.
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Contribute to the metrics provided to Senior Management.
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Complete assigned goals for key QMS elements, with a special focus on Knowledge Management/Regulatory intelligence activities and oversight.
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Undertake other duties as assigned.
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Educated to degree level (technology, biological science, pharmacy, or other health-related discipline preferred) or equivalent qualification or clinical research experience.
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Experience in Quality Assurance, Quality Management, Regulatory Affairs, Clinical Research, Monitoring, Data Management, Pharmacy, Laboratory, or other relevant areas.
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Good understanding of regulatory affairs landscape
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Experience working with clinical trials
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Project management capabilities applicable to Regulatory Intelligence activities and oversight.
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Excellent interpersonal, verbal, and written communication skills, including the ability to present at meetings and training sessions.
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Ability to rapidly learn, understand, and apply applicable corporate procedures.
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Excellent time management skills, with the ability to prioritize workload and manage multiple tasks/projects with enthusiasm.
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Ability to lead projects and teams.
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Strong ability to analyze and interpret data.
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Attention to detail and advanced organizational skills.
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IT literate, with a strong ability to work with Microsoft-based applications and relevant Regulatory Intelligence applications such as Cortellis or Tarius
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Proficiency in written and oral English.
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