Medical & Regulatory Affairs Director Italy

1 settimana fa

Roma, Lazio, Italia Ipsen A tempo pieno

Title:
Medical & Regulatory Affairs Director ItalyCompany:Ipsen SpA

Job Description:
Job title: Medical & Regulatory Affairs DirectorDepartment: Medical & Regulatory Affairs Director

Line Manager:

Country General ManagerPurpose 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 (LMA, GMA, DD) 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 and tasksStrategy 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 & monitoring Supervise, 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 Ipsen in congressesRegularly visit customersOrganisation and People developmentPropose and lead optimal marketing/sales organisationEnsure recruitment, development and retention of staffEnergise 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 Ipsen procedures and working standards and SOPs, and particularly the implementation of the Ethical Code of Conduct within the Business UnitExperience / QualificationsEducationMinimum:

Science/Medical related qualifications at a Post Graduate levelFluency in English Hospital 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 teamExperienceIdeally 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, maintenanceP&L managementInternational experience is a plusRequired CompetenciesTechnical skillsExtensive product/products specialty markets experience and knowledge Established relationships with KOLs, patient groups, etc.

Strong 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 abilities#LI-PN1Thank you for considering Ipsen as an employer of choice.

We wish you all the best with your application.

SummaryLocation:

MilanoType:
Full time

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