Associate Director – Market Access Operations & Excellence

Jobtailor; Beerse; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Jobtailor is seeking a senior role focused on EU HTA Regulation readiness and execution within Global Market Access. You will drive JCA processes, coordinate regulatory interactions, and lead cross-functional teams across therapy areas to ensure timely, compliant submissions and ongoing post-submission activities.

This position requires extensive experience in Market Access/HTA, regulatory affairs knowledge, and the ability to optimize workflows with digital tools, including AI-enabled

Qualifications

• University degree in life sciences, pharmacy, health economics, public health, or a related field required; advanced degree such as MSc, MPH, PhD, PharmD, or equivalent preferred.
• At least 6 years of experience in Market Access, HTA, Regulatory Affairs, or related fields within a pharmaceutical organization, external agency, or consulting environment.
• Solid understanding of EU HTA Regulation and international HTA processes.
• Cross-therapy-area experience preferred; oncology experience is an advantage.

Responsabilités

• Drive operational excellence across Global Market Access with a primary focus on EU HTA Regulation readiness and execution.
• Operationalize EU HTA across a global portfolio and support timely, high-quality execution of Joint Clinical Assessments and Joint Scientific Consultations.
• Refine, adapt, and implement the internal end-to-end JCA process, including governance, submission readiness, and compliant document management.
• Coordinate and align with Regulatory Affairs on EMA submission and post-submission process steps.
• Lead operational execution and cross-functional coordination of JCA internal PICO scoping, dossier preparation, submission, and post-submission activities, including follow-up interactions with (co-) assessors for relevant assets across Therapy Areas.
• Ensure linkage to related activities such as scientific advice, and partner closely with R&D.
• Drive continuous improvement in the efficiency, quality, and consistency of dossier preparation, quality checks and workflow automation, including appropriate use of artificial intelligence and other digital solutions.
• Support resource planning for JCA-related activities across assets and functions, including budget, FTE capacity, and vendor planning.
• Ensure proactive planning for internal pipeline assets in scope for upcoming EU JCAs.
• Review and synthesize JCA reports to distill key insights and learnings for future programs and understand potential implications for HTA markets globally.
• Support external stakeholder engagement, including interactions with trade associations.
• Deliver training for relevant global stakeholders to enhance understanding of EU JCA processes, roles, responsibilities, and operational requirements.
• Manage submission and post-submission activities for JSCs, including cross-functional coordination and compliant document management.
• Implement and maintain planning, milestone tracking, and knowledge management tools to support transparency, coordination, and compliant ways of working across the HTA & Decision Science team and broader Global Market Access organization.

Connaissances

EU HTA Regulation

Project coordination

Regulatory affairs

Stakeholder engagement

Formation

University degree in life sciences or related field

Advanced degree (MSc/PhD/PharmD) preferred

Description du poste

Responsibilities

• drive operational excellence across Global Market Access, with a primary focus on EU HTA Regulation readiness and execution.
• operationalize EU HTA across a global portfolio and support timely, high-quality execution of Joint Clinical Assessments and Joint Scientific Consultations.
• refine, adapt, and implement the internal end-to-end JCA process, including governance, submission readiness, and compliant document management.
• coordinate and align with Regulatory Affairs on EMA submission and post-submission process steps.
• lead operational execution and cross-functional coordination of JCA internal PICO scoping, dossier preparation, submission, and post-submission activities, including follow-up interactions with (co-) assessors for relevant assets across Therapy Areas.
• ensure linkage to related activities such as scientific advice, and partner closely with R&D.
• drive continuous improvement in the efficiency, quality, and consistency of dossier preparation, quality checks and workflow automation, including appropriate use of artificial intelligence and other digital solutions.
• support resource planning for JCA-related activities across assets and functions, including budget, FTE capacity, and vendor planning.
• ensure proactive planning for internal pipeline assets in scope for upcoming EU JCAs.
• review and synthesize JCA reports to distill key insights and learnings for future programs and understand potential implications for HTA markets globally.
• support external stakeholder engagement, including interactions with trade associations.
• deliver training for relevant global stakeholders to enhance understanding of EU JCA processes, roles, responsibilities, and operational requirements.
• manage submission and post-submission activities for JSCs, including cross-functional coordination and compliant document management.
• implement and maintain planning, milestone tracking, and knowledge management tools to support transparency, coordination, and compliant ways of working across the HTA & Decision Science team and broader Global Market Access organization.

Requirements

• University degree in life sciences, pharmacy, health economics, public health, or a related field required; advanced degree such as MSc, MPH, PhD, PharmD, or equivalent preferred.
• At least 6 years of experience in Market Access, HTA, Regulatory Affairs, or related fields within a pharmaceutical organization, external agency, or consulting environment.
• Experience in Market Access and HTA, with a solid understanding of the EU HTA Regulation.
• Knowledge of national HTA, pricing, and reimbursement processes in key international markets, especially Europe, is preferred; and/or solid understanding of regulatory authority processes, particularly those of the European Medicines Agency.
• Solid understanding of drug development and cross-functional evidence generation.
• Cross-therapy-area experience is preferred; oncology experience is an advantage.

Core Competencies

Demonstrates expertise in EU HTA Regulation readiness and execution, with a strong focus on operational excellence in Market Access. Proficient in managing Joint Clinical Assessments and ensuring compliance in document management and submission processes.