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We are seeking a highly motivated and detail-oriented Quality Specialist (Regulatory Intelligence) 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.
You will collaborate closely with stakeholders, contribute to continuous improvement of our Quality Management System (QMS), and play a crucial role in maintaining our compliance standards.
Key Responsibilities :
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.
Act as the point person for regulatory intelligence related consultancy.
Assist Parexel Quality in the preparation for and follow-up of internal / external audits and inspections, as needed and relevant to Regulatory Intelligence Activities.
Maintain the Regulatory Intelligence SharePoint and filing areas.
Provide technical knowledge where appropriate.
Maintenance of process documents
Collaborate with Parexel Quality to develop and update quality / process documents, tools, and templates in line with regulatory intelligence activities.
Metric Production
Generate metrics on Regulatory Intelligence Activities.
Contribute to the metrics provided to Senior Management.
Miscellaneous
Complete assigned goals for key QMS elements, with a special focus on Knowledge Management / Regulatory intelligence activities and oversight.
Foster a positive, results-oriented work environment.
Communicate in an open, balanced, and objective manner.
Undertake other duties as assigned.
Skills and Experience required for the role :
Educated to degree level (technology, biological science, pharmacy, or other health-related discipline preferred) or equivalent qualification or clinical research experience.
At least 2 years of experience in Quality Assurance, Quality Management, Regulatory Affairs, Clinical Research, Monitoring, Data Management, Pharmacy, Laboratory, or other relevant areas.
Excellent interpersonal, verbal, and written communication skills, including the ability to present at meetings and training sessions.
Customer-focused approach to work.
Ability to rapidly learn, understand, and apply applicable corporate procedures.
Excellent time management skills, with the ability to prioritize workload and manage multiple tasks / projects with enthusiasm.
Project management capabilities applicable to Regulatory Intelligence activities and oversight.
Ability to lead projects and teams.
Strong ability to analyze and interpret data.
Attention to detail and advanced organizational skills.
IT literate, with a strong ability to work with Microsoft-based applications and relevant Regulatory Intelligence applications such as Cortellis.
Proficiency in written and oral English.
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