Joint Clinical Assessment (JCA) Dossier Manager, International HTA Strategy

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio.

Job Description

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 the 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; e.g., to address issues of relative effectiveness and relative safety within a single submission.

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.

As a JCA Dossier Manager, you will lead end-to-end JCA dossier process supporting the strategy development and execution of the JCA dossier. You will provide expertise in EU HTA regulations ensuring that all requirements are met. You will serve as an EU HTA dossier expert for the JCA dossier team, ensuring that the JCA cross functional teams successfully deliver high quality execution of all JCA procedural steps within scope, on time and within budget. You will be a liaison to HTA external authorities and serve as the JCA dossier expert for all Therapeutic Areas and all European countries.

Key Responsibilities

• Lead the resource evaluation of the JCA dossier teams involved.
• Arrange and conduct JCA Strategy Workshops, develop meeting minutes and related action plans, and ensure delivery of activities.
• Provide effective communication of the JCA Dossier team, including liaison with EU HTA Steering Committee, VAT, affiliates and senior management.
• Develop project plans, timelines, budgets and vendor evaluation while holding all stakeholders accountable to meet timelines.
• Act as adviser 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 EU HTA regulation and guidance, and liaise with external European HTA authorities.
• Identify key risks early, propose mitigation strategies and ensure procedural readiness at all stages.
• Act as key contributor in establishing the new framework and capability needed for successful EU HTA Regulation implementation.
• Recommend and implement tactical process improvements while promoting knowledge management and consistent dissemination of best practices across the organization.

Qualifications

• At least 8 years of experience in international market access/HTA related areas (including market access, health economics, HTA, clinical development, biostatistics or Medical Affairs).
• Bachelor's degree; advanced degree in life sciences, health service or related discipline (MSc) preferred.
• Understanding of pricing and reimbursement processes for at least one key HTA market.
• Experience with AMNOG, HAS, NICE, CDA dossier submissions is a plus.
• Understanding of evidence synthesis concepts.
• Proven project management experience in the pharmaceutical industry.
• Strong knowledge of project management software and tools.
• Excellent leadership, interpersonal and communication skills.
• Strong ability to work collaboratively across matrix functions.
• Ability to work independently and make informed decisions.

Key Behaviors

• Inspires and motivates others toward a shared purpose.
• Influences colleagues to achieve cross functional alignment.
• Deals comfortably with risk and ambiguity, changing course when needed.
• Makes timely, high quality decisions with less than perfect information.
• Sets clear strategies and robust implementation plans.
• Translates complex problems into simple ideas and solutions.
• Acts respectfully yet courageously and communicates openly and honestly with all colleagues.
• Connects unrelated concepts, generates original or unique ideas.
• Persistent and resilient, finding ways to move good ideas forward.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled.

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