Global Managed Access Manager

Title:

Global Managed Access Manager

Company:

Ipsen Biopharm Ltd

 

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 company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description:

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 Ipsen’s 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

• 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

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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We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.