Medical Services Manager

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 adboard 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.

Qualifications :

• 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.

Additional Information :

The Medical Services Manager is expected to behave ethically responsibly professionally and show leadership in the adoption of the Sobi values:

• 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 cant wait and the market wont     
• Ownership:           Take decisions and act on them                               
• Partnership:          Work together so we all win        

Recruitment agencies please refrain from reaching out regarding this position as it is managed internally.        .

Remote Work :

No

Employment Type :

Full-time