Regulatory Affairs and Medical Information Specialist 12 month FTC Location: Dublin, Ireland Competitive Salary and Benefits Introduction to role You will provide medical information to external and internal customers upon receipt of queries and report product quality complaints in line with company SOPs.
Deliver and maintain competitive licences for Ireland/Malta, ensuring regulatory compliance for defined product and project responsibilities.
You will be responsible for the preparation, submission, and management of all submissions within the remit of product responsibility.
Ensure compliance with requirements in line with the local Quality Management System (QMS) SOP and all other AZ policies and standards.
Accountabilities Work in close collaboration with other Medical Information colleagues on the provision of a comprehensive medical information service to internal and external customers in line with company and industry standards.
Respond to more complex queries on pharmaceutical products from internal and external stakeholders, escalated by third party vendor.
Identify opportunities to improve processes within Medical Information and provide practical solutions within area of expertise.
Develop standard responses for use as considered appropriate.
Update job aids and liaise with third party vendor to ensure understanding.
Support with the creation, review and update of key local procedural documents.
Assist Medical Information colleagues in covering annual leave or other business absences.
Ensuring that all activities are conducted in an ethical, responsible, and lawful manner as set out in the AZ Global Policies