Medical and Regulatory Affairs Director

1 mese fa

Milano, Italia Scelte Strategiche A tempo pieno
Dettagli PropostaPosizione: Medical and Regulatory Affairs DirectorAzienda: Multinazionale FarmaceuticaLuogo di lavoro: MilanoScelte Strategiche is seeking a Medical & Regulatory Affairs Director for a pharmaceutical multinational company (job location: Milan).Purpose of the positionTo ensure, within Corporate and company strategic and management policies, medical and scientific support of recognized quality to both local and Corporate clinical and clinical – marketing projects aimed to the development and improvement of Products and/or directions, working actively with Marketing for the definition of effective product plans.Manage activities to launch and implement clinical projects, ensuring compliance with regulations and ensuring the achievement of goals and compliance with planned time/ costs.To develop and negotiate, together with GM, the approval and reimbursement process of new products and / or indications, in line with HQ guidelines.To be a member of the Company Donation Committee and guarantor of its operations.To be responsible for the compliance of the Scientific Service.To monitor Regulatory Affairs by holding the relationship with the Ministry of Health / AIFA, Regions and public health institutes at national level.Main responsibilities & tasks of the role:Strategy definitionEnsure the highest level of medical and scientific knowledge about the Company's products and potential evolution guidelines, interacting constantly with Corporate. Represent the company's referee for pharmaceutical and health legislation at national and international level.Ensure the company's presence in the medical and scientific field related to the products of the Company, through monitoring specialist MDs / KOLs, the Research Centers of Excellence and the most validated institutes in the treated medical disciplinesStrategy execution & monitoringSupervise, in close collaboration with Corporate and the Director of Operations, by providing medical and scientific expertise, the identification and definition of the most effective marketing and clinical projects aimed to the improvement and development of products and / or indications for their market success.Control, in collaboration with Regulatory Affairs, the management of local / corporate medical and clinical projects (LMA, GMA, DD), ensuring full compliance with QSE (Quality, Safety, Efficiency) regulatory requirements, Good Clinical Practice (GCP) and ethical guidelines.Supervise and guarantee, as Head of the Scientific Service (RSS) in the company, the quality of the information and business documentation, in compliance with the quality standards and the current legislation.KOLs managementBuild an effective network with the main external interlocutors (KOLs, Scientific societies, communication agencies)Represent the Company in congressesRegularly visit customersOrganization and People developmentPropose and lead optimal marketing/sales organizationEnsure recruitment, development and retention of staffEnergize the team behind common objectives and goalsEnsure cross functional collaboration through brand teamsFoster and develop the action principles within the Business UnitLocal management team memberContribute to cross functional collaboration of local leadership teamParticipate actively to the life of the affiliate, endorse decisions taken on all subjectsEthics & ComplianceEnsure the respect of Company procedures and working standards and SOPs, and particularly the implementation of the Ethical Code of Conduct within the Business Unit.Skills and Experience:Science/Medical related qualifications at a Post Graduate levelHospital product experienceProven track record of working with Pharmaceutical Specialised products, preferably within the Cluster/Country MarketSignificant experience in, and knowledge of, product/products specialty markets with complex science and reimbursementExperience working within an environment of strict compliance to all appropriate regulatory guidelines to successfully design and execute tactics, programs and tools that achieve business objectivesDemonstrated experience in successfully leading and managing a high performing teamIdeally 10 years pharmaceutical medical experience, of which, 5 years as a people managerExtensive product/products specialty markets knowledge and experience in a Pharmaceutical industry environmentSuccessful experience in the management of products life cycle: launch, development, maintenanceExtensive product/products specialty markets experience and knowledgeEstablished relationships with KOLs, patient groups, etc.P&L managementOther competenciesStrong analytical and numerical skills and an ability to manage complex situations and make expedient decisions, execute plans and achieve outcomesExcellent organisation, planning, implementation, budgetary and project management abilitiesFluency in English International experience is a plusLa ricerca è rivolta ad entrambi i sessi (L.903/77).
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