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Global Lead Medical Information New
il y a 1 semaine
Location:
Mechelen
- Contact:
- Job type:
- Contact phone:
- Industry:
For one of our clients, a fast growing Biotech company, we are seeking a Global Lead for Medical Information (MI) to join their team for a project of 6 months.
As Global Lead for Medical Information (MI), you will be responsible for overseeing the MI process and vendor management, content development and updates, reports and trending, compliance, and various other medical information-related activities.
Responsibilities
MI Process and Vendor (First-line MI support) Oversight
- Monitor daily medical information activity and ensure timely responses to inquiries.
Manage the relationship with MI vendors, including scheduling and conducting weekly meetings, monitoring quality and service level, and addressing any issues that arise.
Update Working Practices and Contact Lists to reflect the latest guidelines and team members.- Liaise with country teams, organizing bimonthly meetings, and handle issue escalations and deviations from the standard MI process.
- Perform monthly reconciliations of medical information activities and metrics.
- Track the lifecycle of medical information content and ensure timely updates and approvals in collaboration with a consultant if necessary.
- Identify content needs based on changing regulations, scientific advancements, and customer inquiries.
- Facilitate access to medical information content and updates for internal teams, MI vendors, and business partners.
- Create a quarterly MI Dashboard in collaboration with the vendor's dedicated resource, providing valuable insights and trends in medical information inquiries.
- Conduct monthly analysis of inquiries and escalate key insights to relevant stakeholders.
- Provide support during inspections and audits at both local and global levels, ensuring compliance with regulatory requirements and internal policies.
- Identify deviations from standard practices and assist in developing Corrective and Preventive Actions (CAPAs) when necessary.
- Contribute to the updates of the Pharmacovigilance System Master File (PSMF) with relevant medical information inputs.
- Review and update Standard Operating Procedures (SOPs) related to medical information activities.
- Participate in crossfunctional meetings, providing medical information input as required.
- Act as the primary point of contact for business partners seeking medical information support.
- Conduct medical information training sessions for internal teams during congresses and other relevant events.
Requirements:
- You have a degree in a relevant scientific or healthcare field and minimum 5 years of experience in the pharmaceutical or biotechnology industry, with a significant focus on immunology.
- You have proven experience in managing external vendors and ensuring highquality services
- You have a strong knowledge of medical information processes and guidelines.
- You have excellent communication and interpersonal skills to work effectively with crossfunctional teams globally and vendor.
- You are fluent in English
- You have an analytical mindset with the ability to generate meaningful insights from data and trends.
- You are detailoriented and capable of handling multiple tasks simultaneously in a fastpaced environment.
- You have demonstrated leadership and problemsolving abilities.
- Existing right to work in Europe is required
Benefits
- Fulltime project (Min 80%)
- Fully remote working opportunity
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