EU HTA Dossier Lead (m/f/d) at Merck Sharp & Dohme Corp. /Netherlands

Zurich, Zurich, Switzerland -

Full Time

Start Date

Immediate

Expiry Date

12 Jun, 26

Salary

0.0

Posted On

14 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Asset Leadership, End-to-End Planning, JCA Submission, Cross-Functional Leadership, Stakeholder Alignment, Strategic Leadership, PICO Anticipation, External Representation, Portfolio Learning, Joint Scientific Consultations, Capability Building, HTA Regulation, Market Access, Health Technology Assessment, Strategic Planning, Project Management

Industry

Pharmaceutical Manufacturing

Description

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: Current Employees apply HERE Current Contingent Workers apply HERE 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 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R389390

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Responsibilities

This senior individual-contributor role holds end-to-end accountability for EU HTA delivery, focusing on asset-level planning and execution from PICO anticipation through JCA submission, primarily within oncology through 2028. Key duties involve leading the cross-functional JCA Dossier Team and ensuring strategic alignment between EU-level assessments and national Access, Pricing, and Reimbursement strategies.