Sc Medical Director Nephrology

2 mesi fa


Milano, Italia Kyowa Kirin International A tempo pieno

Overview:
At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We are an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.

**Job Purpose**

Ensure optimal medical and scientific support across the Cluster both externally - to the medical community - and internally. A strategic and operational role, responsible for providing optimal patient care without ever crossing any medical/ ethical/ compliance line for commercial gain.

**This is a hybrid role with both office (Milan) and home working**

**Responsibilities**:

- Creation and/or review of medical materials, e.g., literature reviews, medical letters, slide kits etc.
- Dissemination of knowledge on optimal, evidence-based patient care, through one-on-one conversations, group discussions and/or presentations.
- Provide medical input into regional brand strategy and tactical planning as appropriate and compliant.
- Build and maintain a professional network with relevant members of medical/scientific community, pharmaceutical organisations, patient associations, insurance companies and other applicable institutions. Demonstrate proactive long-term engagement with key opinion leaders, investigators, and external experts in order to improve Kyowa Kirin's understanding of the external environment and the safe and effective options for disease treatment and management.
- Review and approval of marketing materials.
- Input into cross-functional deliverables such as Regulatory Affairs (SmPC updates, DHCP letters, letters to competent authorities) or Market Access (dossiers, tenders etc.).
- Execute Risk Management Plan if applicable.
- Facilitate publication of relevant local scientific and/or patient management data on KKI products.
- Gain and maintain good understanding of the quality system within the company, including PV, product complaint/recall handling and GDP. Capture, document, and process Adverse Events on company products and ensure dissemination of new safety information to all relevant stakeholders, in close collaboration and under the guidance of KKI PV department.
- Liaise with local patient organisations to find out about patients’ needs and required patient support.
- Give input into EMEA issues and projects.
- Obtain and maintain in-depth knowledge on all aspects of the relevant KKI product(s).
- Obtain and maintain in-depth medical, scientific, clinical knowledge of the relevant therapeutic area by following training classes, studying literature, attending scientific sessions at congresses and, importantly, exchanging information with knowledgeable and/or experienced HCPs in the field.
- Obtain and maintain in-depth knowledge of guidelines, codes of practice, relevant local law, internal policies, and SOPs related to clinical research, promotional materials, and activities, as well as informative/educational programs and materials.
- Communicate balanced, substantiated, and relevant scientific information for internal and external stakeholders. Respond professionally to clinical information and data requests in relation to disease or treatment specific questions or off-license queries.
- Ensure appropriate response to unsolicited scientific requests by HCP's for licensed products/brands (on and off label), and for products in development in different clinical trials phases, by providing accurate scientific data in compliance with company policies, and country specific legal and ethical requirements.
- Develop KOL engagement plans and associated patient value insights and outcomes.
- Actively develop agendas for, and participate in, advisory board meetings and clinical investigator meetings.
- Facilitate expert lectures and external expert speakers with national, regional, or global recognition. Provision of scientific support to speakers upon demand.
Attend national, regional, and international scientific meetings, congresses, and symposia to maintain and update therapeutic area knowledge and understand and interact with the expert environment.
- Provide medical support and function as a scientific partner for healthcare professionals.

Qualifications:

- Relevant medical/pharmacy/nursing/bioscience background (higher degree preferred).
- Knowledge of Regulatory Affairs, legal and compliance regulations, and authorities nationally.
- Extensive experience in Medical Affairs Department.
- In-depth knowledge of local, regional, and national healthcare systems and processes for allocation


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