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Novartis

Managed Access Program Manager

Posted 2 Days Ago
Be an Early Applicant
Remote
Hiring Remotely in New South Wales, AUS
Senior level
Remote
Hiring Remotely in New South Wales, AUS
Senior level
Lead country-level Managed Access Programs, Early Access, compassionate use, and Post Study Drug Supply. Translate strategy into operational plans, ensure compliance, coordinate cross-functional logistics (supply, importation, labeling, safety reporting), manage a team (>4 FTEs), oversee vendors, define KPIs, and drive continuous improvement and inspection readiness within Medical Governance frameworks.
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Job Description Summary

We are pleased to share an exciting opportunity for a Managed Access Program Manager within Medical Governance and Excellence.
This role is open due to an internal move and offers a unique opportunity to lead a critical area of patient access, supporting the delivery of early and equitable access to innovative therapies through compliant, high-quality Managed Access Programs and compassionate use initiatives.
The MAP Manager is a strategic and operational leader accountable for the end-to-end oversight of Managed Access Programs, Early Access Programs, compassionate use initiatives, and Post Study Drug Supply at country level.
The role is responsible for translating strategic access decisions into clear operational plans, ensuring that eligible patients can access innovative therapies prior to, or outside of, commercial availability, in alignment with local regulations, Novartis standards, and Medical Governance frameworks.
Leading a high-performing team of more than 4 FTEs, the MAP Manager will ensure operational excellence, strong compliance, capability uplift, and consistent delivery across all MAP activities. The role acts as a key cross-functional integrator across Medical Affairs, Regulatory Affairs, Pharmacovigilance, Supply Chain, Market Access, Commercial, Global Medical Governance, and external partners.
This is a highly visible role that directly supports Medical Affairs strategy and reinforces Novartis’ commitment to patient-centric access.


 

Job Description

  • Lead and develop a high-performing, audit-ready MAP team with clear accountability, strong capability, engagement, and consistent adherence to regulations, SOPs, and governance expectations.

  • Contribute to the development and periodic review of country MAP, early access, and compassionate use strategy in collaboration with Medical Affairs and relevant cross-functional partners.

  • Identify, anticipate, and assess potential future MAPs with Medical, Regulatory Affairs, Market Access, Pharmacovigilance, and Supply Chain, supporting MAP proposals for global review where required.

  • Translate strategic access decisions into clear operational plans and lead end-to-end execution of MAPs, Early Access Programs, and Post Study Drug Supply in line with local regulations and Novartis procedures.

  • Coordinate MAP logistics, forecasting, product availability, importation, labelling, distribution, safety reporting support, and timely delivery to requesting sites.

  • Ensure robust compliance, quality oversight, documentation, risk identification, escalation, inspection readiness, and alignment with Novartis SOPs and Medical Governance frameworks.

  • Act as the country point of contact for MAP-related topics, coordinating with Global Medical Governance, internal stakeholders, external service providers, and relevant working groups.

  • Define and monitor MAP KPIs, oversee vendor qualification and performance, and drive continuous improvement of MAP processes, ways of working, and governance practices.

Ideal background
  • University degree in Pharmacy, Life Sciences, Health Sciences, or a related scientific discipline at Bachelor’s or Master’s level.

  • Advanced scientific, regulatory, or quality qualifications are an advantage, depending on local regulatory complexity and market needs.

  • Local language proficiency, both written and spoken.

  • Minimum 5 years’ experience in pharmaceutical Medical Affairs, clinical operations, logistics, regulatory affairs, or related roles.

  • Demonstrated experience with early access, compassionate use, managed access programs, or clinical trial logistics.

  • Experience working in regulated environments with strong quality, compliance, and governance requirements, including knowledge of MAP and early access regulations and procedures.

  • People leadership experience, ideally including management of a team or cross-functional project teams, with strong collaboration and stakeholder management skills.

  • Strong project management and operational coordination capabilities, including vendor management, KPI tracking, clear communication, analytical thinking, attention to detail, and a patient-centric compliance mindset.

Why this role?

This is an exciting opportunity for an internal candidate to take on a strategic leadership role at the intersection of patient access, medical governance, operational excellence, and cross-functional collaboration.

As MAP Manager, you will help ensure that patients can access important treatments through robust, compliant, and well-governed programs, while leading a capable team and shaping continuous improvement across this critical area.


 

Skills Desired

Clinical Research, Clinical Trials, Drug Development, Health Sciences, Immunology, Internal Medicine, Medical Information, Patient Care, Stakeholder Engagement

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