Regulatory Intelligence Specialist
1 dzień temu
We are seeking a highly motivated and detail-oriented Regulatory Intelligence Specialist to join our team at Parexel. As a key member of our Quality Management System (QMS), you will be responsible for ensuring that our organization stays up-to-date with regulatory updates and implements relevant requirements.
Key Responsibilities:- 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 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.
- Maintain the Regulatory Intelligence SharePoint and filing areas.
- Provide technical knowledge where appropriate.
- Collaborate with Parexel Quality to develop and update quality/process documents, tools, and templates in line with regulatory intelligence activities.
- Generate metrics on Regulatory Intelligence Activities.
- Contribute to the metrics provided to Senior Management.
- Complete assigned goals for key QMS elements, with a special focus on Knowledge Management/Regulatory intelligence activities and oversight.
- Educated to degree level (technology, biological science, pharmacy, or other health-related discipline preferred) or equivalent qualification or clinical research experience.
- Experience in Quality Assurance, Quality Management, Regulatory Affairs, Clinical Research, Monitoring, Data Management, Pharmacy, Laboratory, or other relevant areas.
- Good understanding of regulatory affairs landscape.
- Experience working with clinical trials.
- Project management capabilities applicable to Regulatory Intelligence activities and oversight.
- Excellent interpersonal, verbal, and written communication skills, including the ability to present at meetings and training sessions.
- 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.
- 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 or Tarius.
- Proficiency in written and oral English.
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