Job Description The Medical Compassionate Access Specialist is responsible for leading and managing all aspects of global and local Pre-Approval Access (PAA) programs, unplanned indications, and related compassionate access initiatives within the ANZ affiliate. This includes oversight of outsourced vendor staff, coordination between internal and external stakeholders, and escalation of complex issues to the Head of Medical Affairs Communications. KEY DUTIES AND RESPONSIBILITIES Lead all aspects of global Pre-Approval Access (PAA), local PAA, unplanned indications and other Medical Compassionate Access activities and programs within the ANZ affiliate [in-scope access requests], including management and oversight of outsourced vendor workers and interface with relevant internal and external stakeholders. Escalated as needed to the Head of Medical Affairs Communications. Ensure in-scope access requests are triaged, responded to, and processed according to target timelines. Ensure that safety information is appropriately captured and forwarded to pharmacovigilance and/or Quality Assurance within required timeframes and ensure AE reconciliation activities are completed. Maintain up to date work practices, processes, and procedures relating to in-scope access requests, activities and programs, aligned with current applicable global policies and procedures. Identify and implement improvements, standardization, and innovations relating to in-scope programs. Ensure effective cross-functional ways of working between Medical Compassionate Access, Customer Operations and Order Management teams. Ensure appropriate management of systems, relevant databases, workflows, and documentation specifically relating to in-scope access requests and supply. Compile and review internal metrics relating to in-scope access requests to ensure process governance, escalating to the Head of Medical Affairs Communications as required. Compile and ensure submission of all required regulatory statutory reports for SAS and Section 29 supply as per required timelines. Ensure a state of readiness for internal/external audits relating to in-scope access requests and programs. Escalated as needed to the Head of Medical Affairs Communications. Promote and enhance customer excellence principles within medical compassionate access activities and programs and follow-up on customer feedback as required. Adhere to all relevant external and company policies, procedures, and regulations Support other medical services activities as required from time to time. Report any adverse event within 24 hours as per AbbVie’s policies and procedures. Proactively participate in AbbVie’s WHS programs, adhere to policies and promote a safe work environment at all times. Adhere to AbbVie’s internal codes of conduct and compliance processes.
