Medical Director Romania

The Medical Director Romania will lead the affiliate Medical department, setting and executing Medical Affairs strategies for the affiliate Medical department. They will ensure the affiliate Medical team contributes valuable strategic input to Medical Affairs (MHI) Therapeutic Area strategic medical affairs plans, and local commercial plans, as well as adherence to applicable company standards, policies, and procedures. They will be accountable for the structure and performance of the affiliate pharmacovigilance system and operating to the highest patient safety standards. Instill, and operate within, a culture of ethical and compliant behavior. They will ensure local medical staffing levels are appropriate to meet business requirements; plan, manage and be accountable for the affiliate Medical department budget; provide strategic medical affairs support to cross-functional affiliate teams, as well as leadership, strategic direction and mentorship to direct reports, and fulfill line management responsibilities accordingly. Finally, they will ensure that the Medical department is fully integrated to support the strategy and execution of affiliate business, while being functionally independent. Key Responsibilities Provide Leadership, line management and development of the affiliate’s Medical staff. Ensure appropriate affiliate resourcing, skills and capabilities are in place to support affiliate, regional and International Medical Affairs activities, global research and development activities, and business support. Ensure clarity of roles, responsibilities & accountabilities for the affiliate Medical staff. Responsible for recruiting, retaining, and mentoring high potential employees. In conjunction with the Regional Medical Director, CEE, and local HR ensure that talent management and succession planning activities are undertaken. Plan and manage budget and headcount resources for the affiliate Medical department, in full collaboration and transparency with the affiliate commercial/finance and HR teams, and in consultation with the Regional Medical Director, CEE. Set and execute Medical Affairs strategies for the affiliate in consultation with the Regional Medical Director, CEE, to ensure alignment with region and international/global strategic plans. Provide strategic input to the affiliate’s commercial plans. Development of local clinical research plans. Conduct of local research activities in a scientific, efficient, and compliant way, with due regard to applicable policies, processes and procedures and national regulations, and alignment with areas of strategic research interest for relevant products/therapeutic areas. Develop One R&D culture, by collaborating with and serving as a guide to CSM (Clinical Site Management) teams with ongoing trials in assigned countries. Accountable for the Pharmacovigilance system within the affiliate and ensures that all local regulatory requirements are met. Accountable for robust implementation plans for additional risk minimization measures. Proactively anticipate possible safety signals and ensures close collaboration between functions on all safety topics, including external safety communications e.g. Dear Healthcare Professional Communications. Ensure that the affiliate operates an effective promotional material review & approval process, and act if applicable as per local material review process as final medical signatory (may be delegated) for all promotional and scientific materials / activities within the affiliate. Act as final medical signatory (may be delegated) on all other relevant documents such as label changes, ensuring compatibility of materials with the local label. Establish medical and scientific information service for AbbVie products and products in development and ensure that medical information is of high quality and communicated in an accurate, balanced, timely and compliant way. Provide medical support for and help develop and maintain professional and credible relationships with external experts and academic centers. Identify appropriately qualified external local experts who would wish to engage in collaborative efforts – such as potential research collaborations – with AbbVie; ensure a high level of scientific integrity in these collaborative efforts. Be a strategic collaborator in, and contributor to, the affiliate FutureFit and Brand Teams, and 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, mitigation planning as well as implementation and monitoring of 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 at large. 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 in collaboration with CEx and MHA Operations to drive optimal Medical Affairs performance. Qualifications Medical Degree (or equivalent scientific background); Strong background in clinical practice. Suitably qualified individuals from a scientific background and relevant experience will also be considered. Previous medical affairs pharmaceutical or biopharmaceutical industry experience is essential, and management experience of medical teams & significant numbers of medical/scientific staff for 5 years (minimum) is expected. Demonstrated ability to build and lead a medical/scientific organization of a size similar to that in the affiliate. A broad and demonstrated understanding of drug development and commercialization processes, have sound and current knowledge of the regulatory environment, significant experience in overseeing or conducting clinical trials, a solid understanding of trial design and methodology and an understanding of the need to balance safety and efficacy concerns. He/she must have a reputation for leading with high integrity, strong work ethics and compliant behaviour. Must understand and be able to plan, manage and execute budgets effectively. Collaborative, team-oriented approach, and will be adept at developing and supporting relationships across an organization as well as with key external stakeholders and the healthcare community at large. Experience being an active contributor to cross-functional teams and/or working in matrix organizations will be essential. He/she will possess strong communication and presentation skills. Works independently: limited guidance/oversight. Works broadly across functions to facilitate and support the affiliate’s medical and clinical activities as necessary. Must possess the ability to lead with confidence; a motivator of people he/she should have the ability to impart the vision and strategy of the company and of the department to others. A strong business orientation and acumen is desirable. He/she will have the demonstrated ability to participate within an executive team and contribute to the development and implementation of winning strategies for the company overall. A results oriented entrepreneurial spirit with excellent judgment and the ability to operate independently. He/she should possess the presence and credibility to establish and maintain productive relationships with a variety of audiences with an interest in the company including government regulators, the scientific community in both academic and private sector environment and other key stakeholders. Sound judgment, strong planning and organizational skills, and the ability to get things done. Demonstrated strong sense of urgency. Strong leadership, communication, networking, negotiation and presentation skills. Excellent written and spoken communication skills. Fluency in written and oral English and local language is highly desirable in order to facilitate communications between the affiliate medical department, Global and Area Medical Affairs and other AbbVie functional staff. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.