Job Description
This is a rare opportunity to join one of the most exciting young global biopharmaceutical companies, headquartered here in Dublin. With a rich development and commercial pipeline our client is focussed on rare and orphan diseases.
The newly created position of Regulatory Affairs, REMS Co-ordinator will report to the Head of Regulatory Affairs, will be the main administrative point of contact and co-ordinator for the maintenance of the U.S. Risk Evaluation and Mitigation Strategy (REMS) for approved products.
The ideal candidate will have exceptional communication and project management skills. The successful fulfilment of the role relies on the ability to be proactive, clear and transparent with communications.
Job Spec
- Create and manage timelines associated with the maintenance of the REMS for approved products
- Liaise with vendors including the REMS coordination centre to execute on REMS activities
- Working with the REMS Management Team Leader and Executive Sponsors, provide meeting coordination and facilitation to the REMS Management Team, REMS Executive Steering Committee
- Must be able and willing to work with a diverse cross-functional team to ensure accountability to deliverables
- Escalate REMS implementation issues to the REMS Management team and Executive Steering Committee Chairs
- Serve as point of contact, coordinate and attend REMS Management Team and REMS Executive Steering Committee meetings
- Maintain accurate records of meetings, decisions, action items and correspondence associate with the REMS Governance
- May be required to travel to REMS coordinating centre or other vendors
- Assist with the preparation and delivery of training programs and materials for REMS
- Assist with the development, review and QC of REMS reports that are submitted to the FDA
- Collect and organize metric data and other documentation from internal or external sources
- Consolidate information for presentation to the REMS governance teams
- Manage REMS projects, including project planning, budgets, vendors, communication
- Together with the REMS Management Team, contribute to the successful implementation of the REMS
- Support inspections and audits specific to REMS
Person Spec
- B.S in health science required; advanced degree preferred
- Significant pharmaceutical industry experience in Risk Management, Regulatory, Clinical, Medical or equivalent
- Experience in REMS program management preferred
- Understanding of US REMS regulations and requirements
- Excellent verbal and written communication skills
- Excellent planning, organizational, problem solving, and time management skills
- Proven ability to establish sound working relationships with colleagues cross functionally
- Proven experience in group facilitation - ability to drive teams to make decisions & achieve deliverables
- Self-motivated and able to handle multiple complex issues
- Skilled with use of MS Word, MS Excel, MS Project, Visio
Cv to gerry@rftgroup.ie