Medical Services Manager

• 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.

• 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.

• 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.

• 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.

• 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.

• Strong experience in the design and execution of Special Access and Patient Support Programs.
• Ability to work with HCPs, understand needs, show responsiveness, and provide a high-quality HCP experience.
• Demonstrated experience working with patients, patient organisations, and carers such as nurses.
• Ability to work with a variety of external partners and vendors in the creation of successful programs.
• Thorough knowledge of Australian TGA Regulations and Medicines Australia Code of Conduct.
• Self-starter with skills to work autonomously on projects, planning, and organization.
• Team player with excellent written and oral communication and presentation skills.
• Attention to detail, analytical thinking.
• Flexible and ability to prioritise tasks.
• Computer literate in Word, Excel, PowerPoint and Microsoft Tools, and understanding of database design.
• Pharmacovigilance and Medical Information experience within a Pharma company or CRO would be beneficial.
• Solid medical knowledge with qualifications in medical science, pharmacy, nursing, or a clinical background.

• Care: Act in the best interests of patients, colleagues and company
• Ambition: Stay hungry and challenge the status quo
• Urgency: Act now because the patients can't wait and the market won't
• Ownership: Take decisions and act on them
• Partnership: Work together so we all win

Sobi