Global Managed Access Manager

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology Rare Disease and Neuroscience. Supported by nearly 100 years of development experience with global hubs in the U.S. France and the U.K we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration excellence and impact. At Ipsen every individual is empowered to be their true selves grow and thrive alongside the companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!

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Are you ready to lead and innovate in a dynamic patient-focused biopharmaceutical company

Ipsen is a growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients health and quality of life providing effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology Neurosciences and Rare Diseases.

Why Ipsen

• Patient-Focused: The patient is at the heart of everything we do and improving their outcomes is the deliverable of every strategy.

• Employee Care: We care for our employees who are the ambassadors making a real difference.

• Bold Leadership: We attract and develop bold agile entrepreneurial individuals who take full ownership of their decisions.

• Growth Opportunities: We offer a wealth of fulfilling challenges and growth opportunities in a fast-moving game-changing organization.

About the Role

The Global Managed Access Manager executes the allocated Managed Access programs (early access compassionate use post trial access) to time target with high quality compliance and within budget. And drives excellence in Managed Access and manages the:

• Implementation and execution of Access initiatives up to completion (all Therapeutic Areas/all products) with high quality as per Ipsens standards and requirements
• Supervision of Managed Access initiatives when handled by Ipsen affiliates.

This role is critical for the operational delivery and effectiveness of Managed Access initiatives.

Key Responsibilities

• Contribute to operational excellence through process/documentation improvement and knowledge sharing
• For any new Product/Indication (Ipsen development new acquisition or new licensing agreement) works to coordinate with the cross-functional stakeholders from the Asset Team and other Global/Local functions
• As per endorsed strategy by Product/Indication participate in the design of the Managed Access operational aspects
• Develop by Product/Indication the Managed Access documentation (e.g. patient access form order form informed consent form HCP responsibilities)
• Liaise with cross-functional stakeholders to ensure company strategy targets and standards are met
• From inception to completion of Managed Access Program manages the cross-functional activities with different Ipsen departments
• Monitor progress of Managed Access program against established timelines budget and deliverables escalating issues as needed and provide regular update to cross-functional stakeholders
• Manage the day-to-day global vendor operational relationship to ensure successful execution and adherence to service level agreements
• Provide monthly status update of Managed Access programs in the electronic Document Management System (eDMS)
• Ensure that the eDMS for global Managed Access Programs are always up to date by uploading/completing any documentation/information provided by including evidence of safety supporting documents
• Conduct regular quality reviews of in the eDMS
• Ensure the documentation/information is complete prior to closing the program

Qualifications

• Bachelors 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

If you feel that this could be the right next step for you we would be delighted to engage with your application.

Ipsen is committed to fostering a diverse and inclusive workplace where all employees feel valued and empowered. If you feel that this could be the right next step for you we would be delighted to engage with your application.

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