Associate Director Market Access Operations & Excellence

About Innovative Medicine

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Johnson & Johnson Innovative Medicine (JJIM) is currently recruiting for an Associate Director, Global Market Access Operations & Excellence, within the Global Commercial Strategy Organization (GCSO), to be located in Raritan, NJ, United States or Beerse, Belgium.

About the Role

The Associate Director, Global Market Access Operations & Excellence will drive operational excellence across Global Market Access, with a primary focus on EU HTA Regulation readiness and execution. This high-impact role will help operationalize EU HTA across a global portfolio and support timely, high-quality execution of Joint Clinical Assessments and Joint Scientific Consultations.

The role sits within the Global HTA & Decision Science team in the Global Commercial Strategy Organization’s Market Access Center of Excellence and partners closely with Therapy Area and Regional Market Access, R&D, Regulatory Affairs, and other cross-functional teams worldwide, with a strong EMEA interface.

The HTA & Decision Science team helps ensure that development programs across the J&J Innovative Medicine portfolio address the needs of HTA agencies and payers globally. The team provides expertise on HTA and payer evidence requirements, champions access-led development, and supports organizational learning through consistent processes and best practices.

Key Responsibilities

EU HTA Regulation-related activities, including Joint Clinical Assessments (JCAs) and Joint Scientific Consultations (JSCs):

• 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.

Team Operations:

• 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.

Qualifications and Experience

• 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.

Capabilities and Leadership Attributes

• Strong process and project management skills, with the ability to plan, prioritize, and deliver high-quality work compliantly in a matrixed environment with competing priorities and strict timelines. Experience with project management tools and resource planning is preferred.
• Demonstrated ability to quickly review and internalize external agency structures, evidence requirements, and submission processes, and to compare, interpret, and synthesize requirements across multiple agencies.
• Strong attention to detail, with ability to maintain quality and compliance under tight timelines.
• Global mindset with proven ability to collaborate across diverse, cross-functional teams.
• Strong verbal and written communication skills, with the ability to translate complex topics into clear, actionable messages.
• Intellectual curiosity and creativity to challenge existing approaches, identify improvements and alternatives, and develop practical, innovative solutions.
• Demonstrated commitment to continuous learning with ability to adapt to and create structure in ambiguous and evolving external environments

Locations:

• Raritan, NJ, United States, or Beerse, Belgium. Hybrid work model with three days per week in the office and two days from home. Domestic and International travel required, up to 20%.