The Medical Director CZSK will lead the affiliate medical department at AbbVie, setting and executing Medical Affairs strategies in alignment with global and regional plans. This role is responsible for leadership, talent development, budget management, pharmacovigilance, compliance, and serving as the primary medical spokesperson for AbbVie in the region.
What You'll Do
- Lead the affiliate medical department and set/executing Medical Affairs strategies
- Ensure affiliate medical team contributes strategic input to Global Medical Affairs (GMA) Therapeutic Area plans and local commercial plans
- Ensure adherence to applicable company standards, policies, and procedures
- Be accountable for the structure and performance of the affiliate pharmacovigilance system
- Operate to the highest patient safety standards
- Instill and operate within a culture of ethical and compliant behavior
- Provide leadership, line management, and development of the affiliate’s medical staff
- Ensure appropriate affiliate resourcing, skills, and capabilities to support affiliate, regional, and global medical affairs activities
- Ensure clarity of roles, responsibilities & accountabilities for the affiliate medical staff
- Recruit, retain, and mentor high potential employees
- Ensure talent management and succession planning activities are undertaken in conjunction with the Regional Medical Affairs Head and local HR
- Plan and manage budget and headcount resources for the affiliate medical department
- Collaborate with affiliate commercial/finance and HR teams with full transparency
- Consult with the Regional Medical Affairs Head on strategy and resourcing
- Provide strategic input to the affiliate’s commercial plans
- Develop local clinical research plans
- Conduct local research activities in a scientific, efficient, and compliant manner
- Ensure compliance with applicable policies, processes, procedures, and national regulations
- Align local research with strategic research interests for relevant products/therapeutic areas
- Develop One R&D culture by collaborating with and guiding CSM teams with ongoing trials in assigned countries
- Be accountable for the Pharmacovigilance system within the affiliate
- Ensure all local regulatory requirements for pharmacovigilance are met
- Ensure robust implementation plans for additional risk minimization measures
- Proactively anticipate possible safety signals
- Ensure close collaboration between functions on all safety topics
- Manage external safety communications, e.g., Dear Healthcare Professional Communications
- Ensure the affiliate operates an effective promotional material review & approval process
- Act as final medical signatory (may be delegated) for all promotional and scientific materials/activities
- Act as final medical signatory (may be delegated) on all other relevant documents such as label changes
- Ensure compatibility of materials with the local label
- Establish medical and scientific information service for AbbVie products and products in development
- Ensure medical information is of high quality and communicated accurately, balanced, timely, and compliantly
- Provide medical support for developing and maintaining professional relationships with external experts and academic centers
- Identify appropriately qualified external local experts for collaborative efforts such as research collaborations
- Ensure a high level of scientific integrity in collaborative efforts
- Be a strategic collaborator in and contributor to the affiliate FutureFit and Brand Teams
- Ensure medical alignment with local objectives where possible
- Act as the primary contact for medical governance requirements within the affiliate
- Be accountable for understanding compliance requirements, risk identification and assessment
- Develop mitigation planning and implement and monitor appropriate internal controls
- Serve as the company’s key medical spokesperson and primary medical representative with governmental agencies, professional associations, special interest groups, and the healthcare community
- Ensure adherence to applicable company standards, policies, and procedures among affiliate medical staff
- Ensure compliance with all training requirements for staff
- Provide leadership of and analytical measurement approach to medical in-field team excellence
- Collaborate with CEx and Global Medical Affairs Operations to drive optimal Medical Affairs performance
What We're Looking For
- Leadership and line management experience in a medical affairs environment
- Proven ability to set and execute Medical Affairs strategies
- Experience ensuring compliance with company standards, policies, and procedures
- Accountability for pharmacovigilance systems and patient safety standards
- Experience in talent management, succession planning, and mentoring high-potential employees
- Experience planning and managing budgets and headcount in a medical department
- Ability to collaborate with commercial, finance, HR, and regional leadership
- Experience developing and conducting local clinical research in compliance with regulations
- Demonstrated ability to collaborate with Clinical Science Managers (CSMs) and support global trials
- Accountability for pharmacovigilance and risk minimization measures
- Experience managing safety signals and external safety communications
- Experience serving as final medical signatory for promotional and scientific materials
- Ensuring alignment of materials with local label requirements
- Establishing and managing medical information services
- Building relationships with external experts and academic centers
- Contributing to brand and strategic teams with medical input
- Understanding and implementing medical governance, compliance, and internal controls
- Serving as primary medical spokesperson with government and healthcare entities
- Ensuring staff compliance with training requirements
- Driving performance measurement and excellence in medical field teams
Team & Environment
- Affiliate medical team under regional and global medical affairs structure
- Reports to Regional Medical Affairs Head
Benefits & Compensation
- Competitive salary
- Equity
- Other compensation elements
Work Mode
No specific location or flexibility details provided.
AbbVie is an Equal Employment Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.