Expanded Access Programme Manager, Global Rare Diseases

About us Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose : promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better. Chiesi Global Rare Diseases Chiesi Global Rare Diseases is a Chiesi Group’s business unit established in February 2020 and focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders, many of whom have limited or no treatments available. This unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma. Rare unit has a focus on research and product development for lysosomal storage diseases, rare hematology, ophthalmology disorders and rare immunodeficiencies. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care. What we are looking for This is what you will do Reporting to the Head of Expanded Access, the Programme Manager of the Expanded Access Programme will provide operational support to the Head of Expanded Access across the Chiesi Global EAP programs and related medical affairs activities. The successful candidate will work cross functionally and collaborate with expertise areas within global medical affairs as well as regulatory, supply chain, finance, legal and compliance to ensure compliant and effective execution of regional and local EAP initiatives in according with individual country regulations and within agreed company strategy and budgets. You will be responsible for Set-up, delivery, and maintenance of any new and existing EAP programmes. Collaborate with key internal stakeholders to ensure compliant execution of the EAP programme including collaboration with Medical Affairs to ensure any new requests are documented and routed for approval Regulatory to ensure compliant labelling of the product supply Quality to ensure compliance with the Chiesi licences and quality processes Supply chain to ensure availability of product supply and delivery of EAP supplies Finance to ensure the EAP is within pre-approved budget guidelines Legal and compliance to ensure programme compliance External vendors for any country specific EAP requirements For the physicians with patients enrolled in the EAP, ensure provision of EAP protocols and other related documents to ensure safe use of the products and address HCP questions Maintain monthly KPI’s and ensure all EAP programs are within the specified budget. You will need to have Bachelor’s and / or master’s degree in life sciences required Minimum 2 years of experience in managing an expanded access programme within the pharmaceutical industry or CRO Experience managing an external vendor partner required including successful negotiation and management of a contract / budget Highly organised individual with proven project management skills, being able to effectively track process and requests and manage an effective archive of information. Excellent attention to detail. Excellent interpersonal and communication skills. Works effectively in cross-functional and matrix teams; must be adaptable and able to work well within a team and relate effectively with people at all levels of the organization Excellent time management skills; must be adaptable and flexible to manage competing priorities or high priority requests Passionate about making a difference to the lives of patients with rare diseases through directly and indirectly supporting the healthcare professionals (HCPs) that care for them Applies entrepreneurial thinking and spirit, and innovative thinking to improve systems and process Ability to work effectively in a small organization with a hands‑on attitude We would prefer for you to have Working knowledge of legal, regulatory, and compliance regulations and guidelines preferred Location The role can be based in one of Chiesi Affiliates in Europe. What we offer No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way. We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive. Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination. #J-18808-Ljbffr