Advances in scientific and technological research are opening up new, promising treatments for previously difficult to treat diseases, increasing the demand on already constrained healthcare budgets. The challenging economic and political environment is leading Health Technology Assessment (HTA) agencies and payers to demand better outcomes at lower cost to overall health system.   

In 2021 European commission adopted the EU HTA regulation with the key objectives of accelerating patient access to innovative treatments by harmonizing methodologies, establishing predictability and avoiding duplications. For AbbVie, this provides a unique opportunity to demonstrate the value attributes of our assets & strengthen affiliate position in country P&R appraisals. Joint Clinical Assessments is the key component of the EU HTA regulation and comprises the EU HTA dossier that will need to be submitted to the Member State Coordination Group on HTA; eg, to address issues of relative effectiveness and relative safety within a single submission. For AbbVie, JCA will enable better planning of market access strategies across Europe, driving the perception of value, removing redundancies with repetitive dossiers, saving time and ultimately resulting in smoother P&R negotiations, aiming to achieve faster and broader access for patients. 

To succeed in this environment, we (AbbVie) need to fully understand market value drivers, identify the evidence required for Pricing, Reimbursement and Access (PRA), and work with the evidence generating functions to ensure that evidence generated will support successful Joint Clinical Assessments (JCA) and HTA outcome along with PRA negotiations.   

The International HTA Strategy team was established to realize the full value of our assets by strategically informing drug development, evidence generation and HTA submissions, aligned with HTA/payer needs. The primary goals of the function are to ensure HTA evidence requirements are considered early in the development of Abbvie assets and a robust and aligned HTA strategy including EUHTA across the organization in order to ensure the successful launch of Abbvie assets. The International HTA Strategy team oversees EU HTA Regulation implementation for AbbVie and leads JSC and JCA strategy development and execution. 

Purpose  

As a JCA Dossier Manager, you will lead end-to-end JCA dossier process supporting the strategy development and execution of JCA dossier. You will provide expertise in EUHTA regulations ensuring that all requirements are met. Serves as an EU HTA dossier expert for the JCA dossier team. You will ensure the JCA cross-functional teams successfully deliver high quality execution of all JCA procedural steps within scope, on time, and within budget. You will ensure that project objectives are achieved while adhering to quality and regulatory standards. You will serve as a liaison to HTA external authorities. You will serve as the JCA dossier expert for all Therapeutics Areas and all European countries. As EU HTA introduces new requirements and expectations, you will help shape internal operational processes, embed learnings, and build organizational capability in this evolving environment. 

Key responsibilities:  

• Lead the resource evaluation of the JCA dossier teams involved. 
• Arrange and conduct JCA Strategy Workshops, develop meeting minutes, related action plans and ensure delivery of activities. 
• Responsible for effective communication of JCA Dossier team including liaison with EUHTA Steering Committee, VAT, Affiliates and senior management. 
• Responsible for the development of project plans, timelines, budgets and vendor evaluation while holding all stakeholders accountable to meet timelines and conduct activities effectively.  
• Acts as advisor to the JCA core team and coordinate JCA dossier cross-functional teams, including Access Lead, HEOR Strategy, DSS Stats, VAC, Medical Affairs, Regulatory teams and Access affiliates. 
• Oversee evidence retrieval activities and ensure outputs are integrated into the dossier with the HTA writers. 
• Ensure adherence to regulation requirements and quality standards specific to the EUHTA regulation and guidance Responsible for the liaison with external European HTA authorities. 
• Identify key risks early, propose mitigation strategies, and ensure procedural readiness at all stages. Challenges conclusions when necessary. 
• Act as key contributor for establishing the new framework and capability needed for successful EUHTA Regulation implementation. 
• Recommends and implements tactical process improvements while promoting knowledge management and consistent dissemination of best practices across the organization.