Job Description

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\xe2\x80\x99s 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).

Key Measures of Success

• 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

Tasks

• 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

QualificationsThe knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge, or the equivalent.Minimum Requirements

• Medical Education (MD) or Pharmacy Degree (PharmD), PhD or MSc in Life Science Field
• Minimum of 6 years\xe2\x80\x99 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

Preferred Requirements

• Medical Education (MD)
• Medical specialization and/ or clinical / research experience in nephrology and/or cardiology
• 6 years\xe2\x80\x99 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)

About CSL ViforCSL Vifor aims to become the global leader in iron deficiency and nephrology.The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.For more information, please visit viforpharma.comWe want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about at CSL.Do work that matters at CSL Vifor!

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