Job Description Purpose Operate as key "customer facing" medical team member bringing excellence in the customer experience from patients to HCPs. Build relations with hematology, immunology and oncology KOLs and nurses, to understand patient needs. Manage special access programs, in collaboration with the global Sobi medical team. Contribute to the management of patient support programs. Support the development of medical education materials (in collaboration with Marketing). Support medical pre-launch and product development activities. Be responsible for the Pharmacovigilance and medical information services. Responsibilities Patient Access / Support Programs Coordinate Special Access and Patient Support programs in collaboration with cross-functional, global teams, and external vendors. Develop accompanying support and educational materials together with HCPs and commercial team members. Evolve the application forms, patient consent forms and SOPs to ensure the programs remain current. Align the Special Access programs according to local and global SOPs. Ensure that procedures and software systems are in place to support the reporting needs of internal and external customers. Maintains accurate records for patients on the program. Ensure new patient applications meet regulatory and program requirements. Ensure patients receive supply of medication quickly and continue to be supplied with treatment without interruption. Oversees stock management within warehouse, hospitals, and pharmacies to minimise loss and ensure compliance with TGA guidelines. Maintains collaborative relationships with external customers in-order to enhance the value of programs in the market. Medical Affairs Activities Provide input to cross-functional business planning activities and strategies. Capture insights from the HCPs and patients, and report back to cross-functional team. Lead the development of medical educational materials. Assist with the organization of medical events (such as ad—board, round-tables, Rare Afternoon) Provide input to regulatory activities, in particular Risk Management Plans (RMPs). Establish strategic relationships with key opinion leaders, customers, and government / Industry bodies. Support review of promotional materials and ensure adherence to the MA Code of Conduct through all activities. Medical Information Support external medical information consultants in providing timely responses to medical enquiries received from external and internal customers within Australia and New Zealand. Address medical information requests arising from external engagements or proactive requests from customers in collaboration with external medical information consultant services. Informs the Medical Lead of any enquiries or trends which have Medical, Regulatory or Commercial implications. Pharmacovigilance (PV) Support Support Sobi ANZ external PV consultants in: Maintaining a strong working knowledge of the Sobi local and global PV requirements. Overseeing that AEs arising from all sources including post-market, clinical trials, or non-interventional studies (e.g. registries, surveys) and for investigator-initiated studies supported by the organisation are captured and handled by Sobi partners. Oversee contracts related to PV between the affiliate and business partners (including distributors, market research suppliers) are in place and regularly reviewed. Maintain strong working knowledge of the local PV regulatory requirements. Ensure implementation and tracking of RMPs. Work closely with global PV to maintain PV System Master Files for affiliate.
