Medical Compassionate Access Specialist

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 AbbVies policies and procedures.
• Proactively participate in AbbVies WHS programs adhere to policies and promote a safe work environment at all times.
• Adhere to AbbVies internal codes of conduct and compliance processes.

Qualifications :

• 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 Australias 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.

Additional Information :

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 doesnt 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. Were never satisfied with good enoughpatients 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 Companys 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  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time