Building Safety Manager ensuring compliance and safety standards for high - risk residential environments. Collaborating with regulatory agencies and managing safety tasks and resident engagement.
About the role
- Global Managed Access Manager executing Managed Access programs at Ipsen, a specialty-driven biopharmaceutical company focused on patient-oriented therapeutic solutions.
Responsibilities
- Execute the allocated Managed Access programs (early access, compassionate use, post trial access) to time, target, with high quality, compliance and within budget.
- Drive excellence in Managed Access and manage the implementation and execution of Access initiatives up to completion (all Therapeutic Areas/all products) with high quality as per Ipsen’s standards and requirements.
- Supervise Managed Access initiatives when handled by Ipsen affiliates.
- Contribute to operational excellence through process/documentation improvement and knowledge sharing.
- For any new Product/Indication (Ipsen development, new acquisition or new licensing agreement), coordinate with the cross-functional stakeholders from the Asset Team and other Global/Local functions.
- Participate in the design of the Managed Access operational aspects.
- Manage the cross-functional activities with different Ipsen departments from inception to completion of Managed Access Program.
- Monitor progress of Managed Access program against established timelines, budget and deliverables, escalating issues as needed and provide regular updates to cross-functional stakeholders.
- Manage the day-to-day global vendor operational relationship to ensure successful execution and adherence to service level agreements.
- Ensure that the eDMS for global Managed Access Programs are always up to date by uploading/completing any documentation/information provided, including evidence of safety supporting documents.
Requirements
- Bachelor’s degree required ideally Healthcare Professional qualifications (pharmacist, etc.) or an advanced degree (MS/MBA/MPH/PhD) in a health sciences related field.
- Minimum 5 years of experience in the biotechnology or pharmaceutical industry
- 2 years in Managed Access project management
- Full understanding of business processes
- Good understanding of global regulatory and compliance requirements for Managed Access, clinical research, including but not limited to good knowledge of medical terminology, GxP, and data protection regulations.
- Demonstrated ability to provide strong direct global leadership/project management skills
- Exceptional critical thinking to help identify educational gaps, analyze findings and make recommendations while articulating next steps
- Fluency in English
Benefits
- Employee Care: We care for our employees, who are the ambassadors making a real difference.
- Growth Opportunities: We offer a wealth of fulfilling challenges and growth opportunities in a fast-moving, game-changing organization.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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