Medical Compassionate Access Specialist

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

AbbVie is an equal opportunity employer, and dedicated to fostering an inclusive, flexible, and supportive workplace that values and respects every individual. We are committed to operating with integrity, driving innovation, transforming lives, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability. We ensure a fair and inclusive recruitment process without discrimination against any employee or applicant because of, and not limited to, race, religion, age, physical or mental disability, gender identity or expression, sexual orientation, or marital status. Our hiring process is flexible and accessible, so if you have any specific requests or accessibility requirement, please feel comfortable to let our team know by emailing CareersANZ@abbvie.com or speaking with your Recruiter and we'll make any necessary adjustments to accommodate your needs.

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.

• BPharm or other clinical/health related degree within the life sciences field
• Relevant experience in a pharmaceutical industry role or clinical/health related role; previous healthcare related program management an advantage.
• Demonstrated ability to effectively communicate at all levels both internally and externally.
• Experience in documentation and database management.
• Demonstrable experience in process improvement.
• Ability to understand and interpret Product Information documents and medical treatment concepts
• Excellent organisational and time management skills
• Excellent verbal and written communication skills
• Strong computer skills with MS Office applications and informational databases.
• Ability to effectively work independently, prioritise, and meet established deadlines.
• Attention to detail with a results focused enterprise mindset
• Team player and ability to collaborate with cross-functional stakeholders
• Data visualisation and analytical skills related to the production of reports detailing key metrics.

Flexibility and Availability: In line with Australia’s 'Right to Disconnect' legislation, we recognise and respect employees' right to refuse contact outside of their working hours, unless such refusal is deemed unreasonable. As we operate in an international, matrixed environment, there may be occasions where your role requires participation in business meetings outside of standard hours. We value and support flexibility and appreciate your willingness to occasionally accommodate these requests to ensure effective collaboration and communication within our global team.

WAYS WE WORK

• All For One Abbvie; We weigh all decisions against the common good. We inspire, share and create as a team. We solve problems for all rather than serving our immediate team.
• Decide Smart & Sure; We make intelligent decisions to create the best outcomes. We act quickly, embrace experimentation, and learn what doesn’t work and get on to what does.
• Agile & Accountable; We streamline and eliminate unnecessary obstacles. We plan but adapt as we go. We delegate and make tough decisions to ensure focus on results, staying keenly aware of the urgency in all we do.
• Clear & Courageous; Open, honest, candid dialogue is core to our work and how we act with each other. We share information freely and continuously to find solutions. We admit mistakes. We grow stronger by putting the courage of our conviction to the test.
• Make Possibilities Real; We question with endless curiosity. We’re never satisfied with good enough—patients depend on us to deliver more. We challenge ourselves to find creative, constructive solutions to turn possibilities into reality.

CODE OF CONDUCT & BUSINESS INTEGRITY STATEMENT

• AbbVie is committed to observing high integrity and ethical standards in all its business dealings with our customers, with each other, business partners and suppliers. 
• AbbVie as a responsible corporate citizen will adhere to these standards, as well as to local, national and international laws. 
• All AbbVie employees are responsible for maintaining the Company’s reputation for conduct in accordance with the highest level of business integrity, ethics and compliance with the law. 
• Soliciting and/or accepting/attempting/offering bribes or any illegal gratification is therefore cause for immediate dismissal. 
• AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. 

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

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