Medical & Regulatory Affairs Director Italy

6 mesi fa

Milano, Italia Ipsen SpA A tempo pieno

Job title**:Medical & Regulatory Affairs Director**

Department: Medical & Regulatory Affairs Director

Line Manager: Country General Manager

**Purpose of the position**

To 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 tasks**

**Strategy definition**
- Ensure 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 disciplines

**Strategy 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 management**
- Build an effective network with the main external interlocutors (KOLs, Scientific societies, communication agencies)
- Represent Ipsen in congresses
- Regularly visit customers

**Organisation and People development**
- Propose and lead optimal marketing/sales organisation
- Ensure recruitment, development and retention of staff
- Energise the team behind common objectives and goals
- Ensure cross functional collaboration through brand teams
- Foster and develop the action principles within the Business Unit

**Local management team member**
- Contribute to cross functional collaboration of local leadership team

**Ethics & Compliance**
- Ensure the respect of Ipsen procedures and working standards and SOPs, and particularly the implementation of the Ethical Code of Conduct within the Business Unit

**Experience / Qualifications**

**Education**

Minimum:

- Science/Medical related qualifications at a Post Graduate level
- Fluency in English
- Hospital product experience
- Proven track record of working with Pharmaceutical Specialised products, preferably within the Cluster/Country Market
- Significant experience in, and knowledge of, product/products specialty markets with complex science and reimbursement
- Experience working within an environment of strict compliance to all appropriate regulatory guidelines to successfully design and execute tactics, programs and tools that achieve business objectives
- Demonstrated experience in successfully leading and managing a high performing team

**Experience**
- Ideally 10 years pharmaceutical medical experience, of which, 5 years as a people manager
- Extensive product/products specialty markets knowledge and experience in a Pharmaceutical industry environment
- Successful experience in the management of products life cycle: launch, development, maintenance
- P&L management
- International experience is a plus

**Required Competencies**

**Technical skills**
- Extensive 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 outcomes
- Excellent organisation, planning, implementation, budgetary and project management abilities

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