Responsibility

• Work closely with Therapeutic Area (TA) team by leading in the medical function to accomplish their objectives in a compliant manner and following company values and strategies
• Drive the development of the local medical strategy via therapeutic area clinical knowledge and insight from HCP interactions, with potential to expand regionally in the future
• Development and compliant implementation of the annual country TA medical plan, ensuring alignment with the cross functional TA strategic imperatives as well as Global TA medical plans
• Closely collaborate with colleagues in the development and implementation of the local TA strategy
• Establish effective clinical engagement with external medical experts, medical / scientific associations and other external stakeholders (e.g. patient advocacy groups, payer organizations)
• Development and implementation of TA data generation plan, incl. local data gap analysis for TA
• Oversees management of research grants (incl. investigator-initiated studies) for TA
• Management of country TA Medical budget
• Compliance of Medical deliverables for TA with local laws, regulations & codes, and company processes
• Registered signatory for country promotional and medical materials
• (Deputy) Local/Regional QPPV/ Local Drug Safety Responsible
• TA Medical team is adequately trained and TA specific trainings are in place for cross-functional partners
• Provide up-to-date, high quality and relevant medical, technical and pharmaceutical information on CSL Vifor designated products to external and internal customers
• Involvement in the company's preparation and management of audits and inspections.
• Provide expertise that support the organisation (e.g. material review and approval, formulary submissions, trainings, and ad-hoc scientific support).
• Act as the point of contact to the local and global team for medical IT systems (including IRMS, PromoMats, Research Solution).

• Demonstrated an aligned collaboration within medical leadership team and cross-functional stakeholders to meet corporate goals
• Respected and consulted by global and medical teams from other countries for local medical expertise
• Medical TA plan implemented to meet medical goals aligned with cross functional plans
• Delivered effective external engagement and medical education initiatives for TA
• Execution of local data generation activities and reliable support for global CSL Vifor sponsored and Investigator-Initiated Studies (IIS) for TA
• Demonstrated effectiveness of the medical team measured by appropriate metrics that are defined by Global Field Medical Excellence in alignment with Regional Medical Head
• Compliance with local laws, regulations & codes, and CSL Vifor processes
• Quality, consistency and effective management of medical information enquiries, incl. documentation
• Local Key Information Documents (KIDS) based on global KIDS, if applicable, in place and up to date
• Successful contribution to internal/external audits or inspections and timely resolution of CAPAs

• Develop and maintain up to date scientific and medical knowledge and expertise (TAs and products)
• Set clear objectives and communicate clearly to the cross-functional team, e.g. clear medical plan including key deliverables for all
• Bring health care / clinical practice expertise, therapeutic area knowledge, medical insights to cross-functional TA team to guide strategic and operational planning
• Ensure close and regular collaboration with TA brand leads and market access to shape the brand strategy and support the local / regional access plans/submissions
• Develop and implement all aspects of annual TA medical plan aligned with TA strategy
• Share local Medical insights, and align local Medical planning and execution with HQ Medical teams
• Plan and track local TA Medical budget
• Deploy TA Medical budget according to strategy
• Manage resources to achieve optimal effect
• Identify, develop and maintain effective engagement with external medical experts and professional organisations
• Be deeply involved in access strategy development and implementation to assure access
• Develop a local evidence generation plan for TA and ensure compliant implementation of data generation activities. Provide medical leadership to Investigator Initiated Studies (IIS)
• Ensure and contribute to compliant implementation of medical communication plan, e.g. disease awareness, medical education, and country congress activities
• Ensure and contribute to compliant implementation of local publication plans, including local congresses and manuscripts
• Enter HCP engagements through CRM
• Analyze and utilize activities of and insight from field through CRM
• Deliver medical training to field based medical team
• Timely response to medical enquiries escalated by local medical information staff
• Development and approval of Local Key Information Documents (LKID) used by medical information to respond to medical enquiries
• Ensure compliance with applicable local and global laws, regulations, guidelines and company policies and procedures in all TA Medical Affairs activities
• Review and approval of local materials

• Medical Education (MD) or Pharmacy Degree (PharmD), PhD or MSc in Life Science Field
• Minimum of 6 years' experience with pharma industry in Medical Affairs and/ or Clinical Development at affiliate level with strong leadership skills and collaboration with global Medical Affairs
• Experience with local health care compliance topics
• Proven relationship building skills with internal and external stakeholders
• Working knowledge of commercialization and business practices as well as budgeting experience
• Basic understanding of Pharmacovigilance and Quality Management
• Excellent oral and written communication skills in English

• Medical Education (MD)
• Medical specialization and/ or clinical / research experience in nephrology and/or cardiology
• 6 years' experience with pharma industry in Medical Affairs and/ or Clinical Development at affiliate level and regional or global headquarters
• Experience with non-interventional study management and conduct
• Fluent in verbal and written English (required) and additional local language (preferred)