EU HTA Dossier Lead (m/f/d)

<p style="text-align:left">Job Description</p><p style="text-align:inherit"></p><p><b>About EU HTA Strategy &amp; Operations</b></p><p></p><p>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 &amp; 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 &amp; 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:</p><p></p><ul><li><p>End-to-end planning, leadership and execution of Joint Clinical Assessments (JCAs)</p></li><li><p>Strategic anticipation and shaping of EU-relevant PICOs in close collaboration with countries and Medical Affairs</p></li><li><p>Embedding new ways of working across regions and functions in response to EU HTA timelines and governance</p></li><li><p>Establishing a strong regional HTA community linking EU, national and global stakeholders</p></li><li><p>Leading Joint Scientific Consultations (JSCs) to inform evidence generation and clinical development</p></li><li><p>Strengthening our company’s leadership position in HTA through operational excellence and system-shaping capability.</p></li></ul><p></p><p></p><p><b>Key Responsibilities – EU HTA Dossier Lead</b></p><p>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:</p><p></p><p>EU HTA Asset Leadership &amp; Accountability</p><ul><li><p>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</p></li><li><p>Act as the single point of orchestration for EU HTA at asset level, ensuring coherent execution across functions, regions and countries</p></li></ul><p></p><p>Cross-Functional &amp; Matrix Leadership</p><ul><li><p>Lead the cross-functional JCA Dossier Team, and build close partnerships with extended team members</p></li><li><p>Drive strategic alignment across global, regional and country Market Access &amp; HTA stakeholders, ensuring EU and national submissions are mutually reinforcing</p></li><li><p>Influence outcomes through expertise, facilitation and trust, without formal line authority</p></li></ul><p></p><p>Strategic Leadership</p><ul><li><p>Develop deep asset and indication expertise to assess, monitor and anticipate EU-relevant PICOs</p></li><li><p>Lead strategic discussions with key stakeholders from Market Access and Medical Affairs to inform PICO positions and prepare for national implications</p></li><li><p>Represent our company externally in PICO explanation meetings and EU HTA interactions</p></li></ul><p></p><p>EU–National HTA Integration &amp; Portfolio Learning</p><ul><li><p>Analyze competitor JCAs and EU HTA outputs; translate learnings into implications for our company’s portfolio, operating model and country strategies.</p></li><li><p>Ensure JCA outcomes are interpreted, contextualized and effectively translated for national HTA and reimbursement decision-making</p></li></ul><p></p><p>Joint Scientific Consultations &amp; Upstream Influence</p><ul><li><p>Lead Joint Scientific Consultations (JSCs) in alignment with key stakeholders &amp; internal governance, providing EU-level HTA input to inform clinical development and evidence generation strategies</p></li></ul><p></p><p>Capability Building &amp; System Development</p><ul><li><p>Contribute to EU HTA readiness, including development of standards, processes and new ways of working</p></li><li><p>Support internal training, upskilling and capability building on EU HTA across regions and functions</p></li></ul><p></p><p></p><p><b>Position Qualifications</b></p><p></p><p></p><p><b>Education</b></p><ul><li><p>Post-graduate degree (MSc or PhD) in Public Health, Health Economics, Health Policy or a related field </p></li></ul><p></p><p></p><p><b>Skills</b></p><ul><li><p>Strategic thinker who connects big-picture EU HTA developments to concrete Access, Pricing and Reimbursement implications</p></li><li><p>Influential collaborator with the ability to lead complex, cross-functional work and drive outcomes without formal authority</p></li><li><p>Exceptional facilitation and written communication skills, able to operate seamlessly between executive-level strategy and detailed dossier execution</p></li><li><p>Strong problem-solving and prioritization capability in a complex, matrixed global environment</p></li><li><p>Demonstrated ability to build trust, align stakeholders and provide strategic counsel to senior leaders and country teams</p></li><li><p>Innovative, entrepreneurial mindset; comfortable shaping new operating models in a rapidly evolving regulatory environment</p></li><li><p>High cultural awareness and ability to work effectively across varied geographies and perspectives</p></li></ul><p></p><p></p><p><b>Experience &amp; Qualifications</b></p><ul><li><p>Minimum 5 years of Market Access / HTA experience working for industry or a HTA agency</p></li><li><p>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</p></li><li><p>Strong country‑level Market Access &amp; HTA background, preferably from a clinical assessment perspective, with a clear understanding of how HTA outcomes inform pricing and reimbursement decisions</p></li><li><p>Experience acting as an institutional representative in national HTA committee discussions and in regulatory and/or HTA scientific advice</p></li><li><p>Hands‑on experience in HTA dossier development and/or medical writing, including clinical evidence synthesis and interpretation, strongly preferred</p></li><li><p>Expert knowledge of the EU HTA Regulation, its policy framework, associated guidance, and interaction with national HTA processes and EU regulatory pathways</p></li><li><p>Strong understanding of the PICO framework as a strategic lever, including the ability to influence and influence PICO discussions</p></li><li><p>Understanding of JCA evidence generation requirements, including tradeoffs related to indirect treatment comparisons, completeness requirements, and information retrieval, enabling solution‑oriented discussions</p></li><li><p>Experience operating at the interface between EMA regulatory and EU/national HTA procedures is a plus</p></li><li><p>Experience aligning regulatory timelines with national HTA planning, including strategic input into launch sequencing and evidence generation</p></li><li><p>Proven ability to lead cross‑functional, matrixed teams through influence rather than authority</p></li></ul><p></p><p><b>Required Skills: </b></p>Global Strategy, Health Technology Assessment (HTA), Leadership, Market Access, Project Management, Public Health, Stakeholder Relationship Management, Strategic Planning, Strategy Development<p></p><p><b>Preferred Skills: </b></p><p style="text-align:inherit"></p><p style="text-align:left">Current Employees apply <a target="_blank" href="https://wd5.myworkday.com/msd/d/task/1422$6687.htmld">HERE</a></p><p style="text-align:inherit"></p><p style="text-align:left">Current Contingent Workers apply <a target="_blank" href="https://wd5.myworkday.com/msd/d/task/1422$4020.htmld">HERE</a></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Search Firm Representatives Please Read Carefully </b><br />Merck &amp; Co., Inc., Rahway, NJ, USA, also known as Merck Sharp &amp; 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. </p><p style="text-align:inherit"></p><p style="text-align:left"><b>Employee Status: </b></p>Regular<p style="text-align:inherit"></p><p style="text-align:left"><b>Relocation:</b></p>No relocation<p style="text-align:inherit"></p><p style="text-align:left"><b>VISA Sponsorship:</b></p>No<p style="text-align:inherit"></p><p style="text-align:left"><b><span>Travel Requirements:</span></b></p>10%<p style="text-align:inherit"></p><p style="text-align:left"><b>Flexible Work Arrangements:</b></p>Hybrid<p style="text-align:inherit"></p><p style="text-align:left"><b>Shift:</b></p>Not Indicated<p style="text-align:inherit"></p><p style="text-align:left"><b>Valid Driving License:</b></p>No<p style="text-align:inherit"></p><p style="text-align:left"><b>Hazardous Material(s):</b></p>N/A<p style="text-align:inherit"></p><p style="text-align:left"><b>Job Posting End Date:</b></p>03/28/2026<p style="text-align:left"><b><span>*A job posting is effective until 11:59:59PM on the day <u>BEFORE</u> the listed job posting end date. Please ensure you apply to a job posting no later than the day <u>BEFORE</u> the job posting end date. </span></b></p>