Senior Market Access Project Manager

Senior Market Access Project Manager

Department: Market Access
Reporting to: Head of Market Access Operations
Location: [To be defined]
Employment type: [To be defined]

Role Purpose

The Senior Market Access Project Manager supports the Head of Market Access Operations in the planning, coordination and execution of Market Access projects across Avanzanite countries and portfolio.

The role acts as a key operational partner to Country Managers (CMs) and General Managers (GMs), supporting them throughout the complete Market Access journey, from strategy development and approval through pricing, dossier development, HTA/P&R submission, payer engagement and achievement of the approved reimbursement, funding or access outcome.

A key responsibility is to understand and interpret the regulatory, legal, technical and operational requirements underpinning local Market Access pathways and translate them into clear actions for country teams. Working closely with Regulatory, Legal, Technical Operations/Supply and other HQ functions, the Senior Market Access Project Manager helps CMs/GMs navigate complex country requirements, identify potential barriers early and drive practical solutions.

The role combines senior project leadership, regulatory understanding, cross-functional coordination and hands-on problem solving, ensuring that approved Market Access strategies are translated into timely and effective execution.

Key Responsibilities

Market Access Project Leadership

• Support CMs/GMs in translating approved Market Access strategies into clear, executable project plans.
• Establish project teams, kick-off meetings, working cadence and collaborative project workspaces.
• Ensure clear ownership, responsibilities, timelines and accountability across project teams.
• Maintain focus on critical milestones and proactively identify dependencies, risks and blockers.
• Drive resolution and timely escalation of issues that may affect project timelines or outcomes.
• Manage multiple country projects simultaneously while maintaining visibility of priorities and critical milestones.

Country Action Plan & Project Tracking

• Support CMs/GMs in developing and maintaining the Country Action Plan as the primary project-management tool throughout execution.
• Ensure activities, responsibilities, milestones, deadlines, dependencies and blockers are clearly defined and regularly updated.
• Facilitate regular cross-functional project meetings and ensure agreed actions are followed through.
• Maintain a clear and reliable overview of progress across assigned countries and projects.
• Support the Head of Market Access Operations in portfolio-level milestone tracking and management reporting.
• Identify emerging issues early and coordinate corrective actions before they become material project blockers.

Market Access Strategy & Governance

• Support CMs/GMs and Headquarters Market Access in the development and maintenance of the Market Access Strategy
  
• Ensure project execution remains aligned with the approved Market Access strategy and pricing boundaries.
• Coordinate preparation for applicable Market Access governance processes.
• Support the Price Approval process by ensuring required information, analyses and cross-functional input are available for decision-making.
• Support preparation and coordination of HTA/P&R Submission Approval, ensuring governance activities are appropriately timed and do not delay planned submissions.
• Recognize material deviations from the approved strategy or pricing boundaries and ensure appropriate escalation and reapproval where required.

Regulatory & Market Access Implementation

• Develop and maintain a strong understanding of the regulatory and procedural requirements underpinning local Market Access pathways across assigned countries.
• Review and interpret relevant legislation, regulations, Health Authority requirements and procedural guidance and assess their implications for Market Access execution.
• Translate complex country-specific requirements into clear actions, responsibilities, timelines and deliverables.
• Support CMs/GMs in identifying regulatory, legal, administrative, technical and supply requirements necessary to achieve pricing, reimbursement and patient access.
• Work closely with Regulatory, Legal, Technical Operations/Supply and other relevant HQ functions to assess requirements and develop practical solutions for country teams.
• Proactively identify regulatory or operational requirements that may become critical dependencies or blockers and ensure they are addressed early.
• Coordinate resolution of issues such as local regulatory requirements, submission eligibility, applicant/MAH requirements, local pack considerations, documentation requirements, supply arrangements and other country-specific prerequisites.
• Ensure relevant regulatory and operational dependencies are incorporated into the Country Action Plan and tracked through resolution.
• Escalate material regulatory or implementation risks to the Head of Market Access Operations where required.

HTA/P&R Dossier Development & Submission

• Coordinate the operational delivery of local HTA/P&R dossier development together with the CM/GM, Head of Market Access, local HTA vendor and relevant expert teams.
• Ensure local HTA vendors receive the appropriate core materials, understand the approved strategy and work to agreed timelines and deliverables.
• Coordinate internal Avanzanite dossier review rounds involving Market Access content, Medical and HEOR experts as applicable.
• Coordinate subsequent MAH review where required by the applicable partnership arrangements.
• Manage review timelines, document flow and implementation of agreed comments.
• Support CMs/GMs in obtaining and coordinating administrative documentation required for submission.
• Ensure dossier development and administrative preparation progress in parallel towards the planned submission date.
• Support submission readiness and timely completion of the external HTA/P&R submission.

Post-Submission Market Access Management

• Continue operational coordination following submission until the approved Market Access outcome is achieved.
• Track Health Authority questions, response deadlines, additional evidence requirements, HTA meetings, payer interactions, negotiations and other critical milestones.
• Coordinate relevant internal and external contributors to ensure timely delivery of responses and analyses.
• Maintain visibility of emerging risks, dependencies and blockers throughout the post-submission process.
• Support preparation for payer negotiations and subsequent governance requirements.
• Support implementation following reimbursement, funding or access approval where applicable.

Cross-Functional & External Collaboration

• Build strong working relationships with CMs/GMs and Headquarters functions across Avanzanite.
• Coordinate collaboration with Market Access, Medical, HEOR, Regulatory, Finance, Legal, Commercial, Technical Operations/Supply, Alliance & Strategic Partnerships and other functions as required.
• Manage operational collaboration with local HTA/P&R vendors and other external Market Access partners.
• Coordinate with MAH Market Access, HEOR and other partner teams where required.
• Promote clear communication, accountability, collaborative problem-solving and timely decision-making across project teams.

Key Interfaces

Internal: Head of Market Access Operations, Head of Market Access, Country Managers, General Managers, Medical Affairs, Regulatory Affairs, Finance, Legal, Commercial, Technical Operations/Supply, Alliance & Strategic Partnerships and other relevant HQ functions.

External: Local HTA/P&R vendors, HEOR partners, Marketing Authorisation Holder teams and other external Market Access or regulatory service providers.

Education & Experience

• University degree in life sciences, pharmacy, health economics, economics, business or a related discipline.
• Significant relevant experience in pharmaceutical or biotechnology Project Management, Market Access, Regulatory Affairs or related functions.
• Demonstrated experience managing complex, cross-functional projects involving multiple countries, stakeholders and external partners.
• Good understanding of the interaction between regulatory, legal, pricing, reimbursement, supply and operational requirements.
• Demonstrated ability to interpret regulations, procedural requirements or Health Authority guidance and translate them into practical implementation requirements.
• Experience working closely with Regulatory, Legal, Medical, HEOR and Technical Operations/Supply functions.
• Experience managing external vendors and expert partners.
• Multi-country European experience strongly preferred.
• Experience in rare diseases, specialty medicines and/or complex or non-standard access pathways is an advantage.
• Excellent written and spoken English; additional European languages are an advantage.

Key Capabilities

Senior project leadership – Takes ownership of complex projects, creates structure and drives delivery across multiple stakeholders and countries.

Regulatory & analytical capability – Able to understand and interpret complex regulatory and procedural requirements, identify their practical implications and determine the expertise required to resolve them.

Cross-functional problem solving – Frames issues clearly, brings together the appropriate expertise and drives practical solutions for country teams.

Planning & execution – Highly structured, with strong attention to timelines, dependencies, deliverables and follow-through.

Judgement & independence – Able to distinguish routine implementation issues from material strategic, regulatory or governance risks requiring escalation.

Stakeholder leadership – Able to coordinate senior internal and external stakeholders effectively without relying on formal authority.

Attention to detail – Maintains accuracy and quality while managing multiple complex projects simultaneously.

Communication – Communicates complex requirements clearly and converts them into understandable actions and decisions.

Collaboration – Builds strong relationships across countries, functions, MAHs and external partners.

Learning agility – Quickly develops understanding of unfamiliar country requirements and navigates evolving regulatory and reimbursement environments.

Ownership & delivery mindset – Proactive, pragmatic and strongly focused on resolving issues and getting things done.

Measures of Success

Success in the role will be demonstrated by:

• Market Access projects progressing against agreed timelines and critical milestones.
• High-quality and consistently maintained Country Action Plans.
• Early identification and timely resolution of regulatory, operational and cross-functional blockers.
• Effective support to CMs/GMs in navigating country-specific Market Access requirements.
• Timely completion of pricing and submission governance requirements without unnecessary delay to execution.
• Efficient coordination of HTA/P&R dossier development, expert review and submission.
• Timely management of post-submission activities and Health Authority/payer requests.
• Strong cross-functional collaboration and effective management of external vendors and partners.
• Accurate and transparent project status reporting.
• Successful achievement of approved Market Access outcomes across assigned countries.

Role Positioning

The Senior Market Access Project Manager is not the owner of HTA scientific content, final pricing strategy or executive Market Access recommendations. These accountabilities remain with the designated Market Access leadership and expert functions.

The role is responsible for ensuring that the approved strategy is translated into coordinated execution, that country requirements are correctly understood and addressed, and that projects move efficiently from strategy through implementation to successful Market Access outcomes.

In simple terms: the role ensures that strategy becomes delivery.