The Unapproved Medicines Access Section of the TGA is seeking to engage multiple APS Level 3 staff on an ongoing and non-ongoing (12 months) basis. The successful candidates will work alongside a dynamic and high-performing team to provide administrative support for the Special Access Scheme (SAS) and Authorised Prescriber access pathways for unapproved therapeutic goods, including medicinal cannabis, nicotine vaping products, other medicines, medical devices and biologicals. The work would be most suited to individuals with experience in administrative support in a healthcare or medical setting. The key duties of the position include Responsibilities include: • Maintain a basic understanding of Special Access Scheme (SAS) and Authorised Prescriber (AP) guidance material and standard operating procedures • Complete allocated tasks under guidance of senior staff, within required service standards and key performance indicators, and compliant with standard operating procedures • Process SAS and AP submissions in the Microsoft Dynamics 365 Customer Relationship Management System (CRM) system with accuracy and efficiency • Maintain/monitor the CRM database and administrative dashboards • Make basic administrative decisions such as determining initial validity of submissions, interpreting basic medical terminology, requesting missing information and matching prescriber details to registration status • Liaise with delegates to provide basic administrative support, co-ordinate approval of urgent applications and amendment of errors, and to refer new products and indications for addition to the database • Collate state/territory approvals with TGA approvals within the TGA service standard • Manage email inboxes including assigning correspondence to the correct area. • Respond to enquiries via telephone and email regarding submission processes, external portal assistance and information on access schemes within TGA service standards and using appropriate templates • Provide high quality customer service when liaising with external and internal stakeholders including medical practitioners, patients and pharmaceutical industry representatives. • Investigate stakeholder issues and suggest resolutions • Escalate complex and/or sensitive issues and correspondence to a senior staff member • Appropriately handle sensitive information in accordance with privacy legislation • Assist in training and supporting new staff members and contribute to updating procedures • Organise and file documentation in TRIM consistent with the TGA Records Management Policy • Perform other duties as requested by senior staff or Director
