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AbbVie logo

Medical Compassionate Access Specialist

AbbVie

Medical Compassionate Access Specialist

AbbVie logo

AbbVie

full-time

Posted: November 7, 2025

Number of Vacancies: 1

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 RESPONSIBILITIESLead 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 regulationsSupport 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.

Locations

  • Mascot, NSW

Salary

Salary not disclosed

Estimated Salary Rangemedium confidence

90,000 - 120,000 USD / yearly

Source: AI estimated from job description

* This is an estimated range based on market data and may vary based on experience and qualifications.

Skills Required

  • Management and oversight of outsourced vendor workersintermediate
  • Interface with relevant internal and external stakeholdersintermediate
  • Escalation of complex issues to the Head of Medical Affairs Communicationsintermediate
  • AE reconciliation activitiesintermediate
  • Process governance and metrics compilationintermediate
  • Regulatory reportingintermediate
  • Audit readinessintermediate
  • Customer feedback follow-upintermediate

Required Qualifications

  • Adherence to AbbVie’s internal codes of conduct and compliance processes (experience)
  • Proactively participate in AbbVie’s WHS programs (experience)

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
  • 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
  • Maintain up to date work practices, processes, and procedures relating to in-scope access requests
  • 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
  • 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
  • Promote and enhance customer excellence principles within medical compassionate access activities and programs
  • Report any adverse event within 24 hours as per AbbVie’s policies and procedures
  • Support other medical services activities as required from time to time

Benefits

  • general: Adhere to all relevant external and company policies, procedures, and regulations
  • general: Promote a safe work environment at all times

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AbbVie logo

Medical Compassionate Access Specialist

AbbVie

Medical Compassionate Access Specialist

AbbVie logo

AbbVie

full-time

Posted: November 7, 2025

Number of Vacancies: 1

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 RESPONSIBILITIESLead 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 regulationsSupport 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.

Locations

  • Mascot, NSW

Salary

Salary not disclosed

Estimated Salary Rangemedium confidence

90,000 - 120,000 USD / yearly

Source: AI estimated from job description

* This is an estimated range based on market data and may vary based on experience and qualifications.

Skills Required

  • Management and oversight of outsourced vendor workersintermediate
  • Interface with relevant internal and external stakeholdersintermediate
  • Escalation of complex issues to the Head of Medical Affairs Communicationsintermediate
  • AE reconciliation activitiesintermediate
  • Process governance and metrics compilationintermediate
  • Regulatory reportingintermediate
  • Audit readinessintermediate
  • Customer feedback follow-upintermediate

Required Qualifications

  • Adherence to AbbVie’s internal codes of conduct and compliance processes (experience)
  • Proactively participate in AbbVie’s WHS programs (experience)

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
  • 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
  • Maintain up to date work practices, processes, and procedures relating to in-scope access requests
  • 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
  • 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
  • Promote and enhance customer excellence principles within medical compassionate access activities and programs
  • Report any adverse event within 24 hours as per AbbVie’s policies and procedures
  • Support other medical services activities as required from time to time

Benefits

  • general: Adhere to all relevant external and company policies, procedures, and regulations
  • general: Promote a safe work environment at all times

Target Your Resume for "Medical Compassionate Access Specialist" , AbbVie

Get personalized recommendations to optimize your resume specifically for Medical Compassionate Access Specialist. Takes only 15 seconds!

AI-powered keyword optimization
Skills matching & gap analysis
Experience alignment suggestions

Check Your ATS Score for "Medical Compassionate Access Specialist" , AbbVie

Find out how well your resume matches this job's requirements. Get comprehensive analysis including ATS compatibility, keyword matching, skill gaps, and personalized recommendations.

ATS compatibility check
Keyword optimization analysis
Skill matching & gap identification
Format & readability score

Tags & Categories

Research & DevelopmentAbbViePharmaceuticals

Related Jobs You May Like

No related jobs found at the moment.