EU HTA Dossier Lead (mfd)

Job Description

About EU HTA Strategy & Operations

Within International Access we work across regions to enable optimal patient access to our companys medicines and vaccines at a price reflective of their value. The HTA Strategy & Policy function plays a critical role by anticipating shaping and responding to the evolving HTA environment across Europe. The implementation of the EU HTA Regulation represents a fundamental shift in how clinical value is assessed and how evidence informs national Access Pricing and Reimbursement decisions. To respond to this change EU HTA Strategy & Operations is building new enterprise capabilities to operationalize EU HTA end-to-end and to ensure tight alignment between EU-level Joint Clinical Assessments (JCAs) and national HTA submissions. The teams mandate includes:

• End-to-end planning leadership and execution of Joint Clinical Assessments (JCAs)

• Strategic anticipation and shaping of EU-relevant PICOs in close collaboration with countries and Medical Affairs

• Embedding new ways of working across regions and functions in response to EU HTA timelines and governance

• Establishing a strong regional HTA community linking EU national and global stakeholders

• Leading Joint Scientific Consultations (JSCs) to inform evidence generation and clinical development

• Strengthening our companys leadership position in HTA through operational excellence and system-shaping capability.

Key Responsibilities EU HTA Dossier Lead

The EU HTA Dossier Lead is a senior individual-contributor leadership role with asset-level end-to-end accountability for EU HTA delivery. The role sits at the intersection of EMA regulatory EU and national HTA leading the EU HTA part and supporting the translation of EU-level assessments into meaningful implications for country Access Pricing and Reimbursement strategies. Key responsibilities include:

EU HTA Asset Leadership & Accountability

• Own end-to-end EU HTA planning and execution at asset level (oncology focus through 2028) from early PICO anticipation through JCA submission and downstream impact assessment

• Act as the single point of orchestration for EU HTA at asset level ensuring coherent execution across functions regions and countries

Cross-Functional & Matrix Leadership

• Lead the cross-functional JCA Dossier Team and build close partnerships with extended team members

• Drive strategic alignment across global regional and country Market Access & HTA stakeholders ensuring EU and national submissions are mutually reinforcing

• Influence outcomes through expertise facilitation and trust without formal line authority

Strategic Leadership

• Develop deep asset and indication expertise to assess monitor and anticipate EU-relevant PICOs

• Lead strategic discussions with key stakeholders from Market Access and Medical Affairs to inform PICO positions and prepare for national implications

• Represent our company externally in PICO explanation meetings and EU HTA interactions

EUNational HTA Integration & Portfolio Learning

• Analyze competitor JCAs and EU HTA outputs; translate learnings into implications for our companys portfolio operating model and country strategies.

• Ensure JCA outcomes are interpreted contextualized and effectively translated for national HTA and reimbursement decision-making

Joint Scientific Consultations & Upstream Influence

• Lead Joint Scientific Consultations (JSCs) in alignment with key stakeholders & internal governance providing EU-level HTA input to inform clinical development and evidence generation strategies

Capability Building & System Development

• Contribute to EU HTA readiness including development of standards processes and new ways of working

• Support internal training upskilling and capability building on EU HTA across regions and functions

Position Qualifications

Education

• Post-graduate degree (MSc or PhD) in Public Health Health Economics Health Policy or a related field

Skills

• Strategic thinker who connects big-picture EU HTA developments to concrete Access Pricing and Reimbursement implications

• Influential collaborator with the ability to lead complex cross-functional work and drive outcomes without formal authority

• Exceptional facilitation and written communication skills able to operate seamlessly between executive-level strategy and detailed dossier execution

• Strong problem-solving and prioritization capability in a complex matrixed global environment

• Demonstrated ability to build trust align stakeholders and provide strategic counsel to senior leaders and country teams

• Innovative entrepreneurial mindset; comfortable shaping new operating models in a rapidly evolving regulatory environment

• High cultural awareness and ability to work effectively across varied geographies and perspectives

Experience & Qualifications

• Minimum 5 years of Market Access / HTA experience working for industry or a HTA agency

• Demonstrated leadership of endtoend national HTA dossier development and submission at national and/or EU level (e.g. EUnetHTA21 EU HTA JCA) or having served as assessor at the HTA agency side

• Strong countrylevel Market Access & HTA background preferably from a clinical assessment perspective with a clear understanding of how HTA outcomes inform pricing and reimbursement decisions

• Experience acting as an institutional representative in national HTA committee discussions and in regulatory and/or HTA scientific advice

• Handson experience in HTA dossier development and/or medical writing including clinical evidence synthesis and interpretation strongly preferred

• Expert knowledge of the EU HTA Regulation its policy framework associated guidance and interaction with national HTA processes and EU regulatory pathways

• Strong understanding of the PICO framework as a strategic lever including the ability to influence and influence PICO discussions

• Understanding of JCA evidence generation requirements including tradeoffs related to indirect treatment comparisons completeness requirements and information retrieval enabling solutionoriented discussions

• Experience operating at the interface between EMA regulatory and EU/national HTA procedures is a plus

• Experience aligning regulatory timelines with national HTA planning including strategic input into launch sequencing and evidence generation

• Proven ability to lead crossfunctional matrixed teams through influence rather than authority

Required Skills:

Preferred Skills:

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