Job Description:

About EU HTA Strategy & Operations

Within International Access, we work across regions to enable optimal patient access to our company’s 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 team’s 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 company’s 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

EU–National HTA Integration & Portfolio Learning

• Analyze competitor JCAs and EU HTA outputs; translate learnings into implications for our company’s 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 end‑to‑end 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 country‑level 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

• Hands‑on 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 solution‑oriented 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 cross‑functional, matrixed teams through influence rather than authority

Required Skills:

Global Strategy, Health Technology Assessment (HTA), Leadership, Market Access, Project Management, Public Health, Stakeholder Relationship Management, Strategic Planning, Strategy Development

Preferred Skills:

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Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

03/28/2026

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