Medical Director

Medical Director

Norgine

Milan, Italy

We have an exciting opportunity for a Medical Director to join Norgine in Italy.

The person holding this position will report to the VP of Medical Affairs and be a member of the Medical Affairs team.

The core responsibility of the Medical Director is to lead the local medical department, be a part of pan-European R&D projects and work closely with other medical departments in the Norgine group and also other functions, such as Regulatory Affairs and the Business Units. This will be a permanent role.

KEY RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

Medical Affairs

• Lead and develop the Affiliate Medical Affairs department in a way that ensures full accountability and compliance with regulations;
• Develop and maintain in-depth knowledge of the company’s products, the relevant therapeutic areas and the structure and workings of the local national healthcare systems;
• Ensure relationships in relevant therapeutic areas are built with Key External Experts, Scientific Societies and patient advocacy groups/patient organisations;
• Support the medical education of Norgine staff and Healthcare professionals as needed.

Regulatory and Compliance Management

• Lead the importance of medical aspects of healthcare compliance and ensure all Medical Affairs activities (like copy approval) are compliant with Norgine policies and processes for promotion of medicines and devices; provision of information to patients and the public; relationships with patient groups and contacts with healthcare providers and/or institutions. Including being the registered healthcare compliance lead (Information Officer/Scientific Service Responsible) as required under local requirements;
• Provide local medical oversight and input into pharmacovigilance activities as required;
• Act as local PV contact person/local QPPV as required locally. Participate in regulatory inspections as required.

Clinical Trials

• Provide input into global data generation planning and clinical trial programs for drugs, medical devices, or medical procedures; ensure that programs meet the standards of excellence for ethics, scientific merit, and regulatory compliance;
• Ensure Norgine sponsored studies are supported in the local countries in agreement with Norgine SOPs and instructions;
• Be responsible for local Norgine IST supporting activities including the review of all local IST proposals submitted to the Affiliate and oversight of ongoing studies.

Internal Client Relationship Management

• Work closely with General Manager and Business Units to manage relationships with strategic internal clients and act as a business partner to them, building high levels of professional credibility and mutual trust, and mobilizing appropriate internal and/or external resources to support in delivering business strategy and plans.

Compliance Responsibility

• Complies with applicable rules, laws, regulations and guidance governing their role responsibilities. Adhere to Norgine compliance policies as well as applicable compliance laws (Legislative Decree 231/2001 and to the extent applicable, Legislative Decree 24/2023 and Law 62/2022), sector codes for promotional practices and data protection laws.

TASKS

• Act as local PV contact person/local QPPV as required locally and Scientific Service Responsible recorded in AIFA.

Requirements

• Medical degree preferred. Scientific masters degree (e.g. pharmacy) may be acceptable;
• Substantial general work experience together with comprehensive job related experience in own area of expertise to fully competent level. (Suggested 6 to 10 years);
• Around 4 years experience in Medical Affairs in the pharmaceutical industry including copy approval and all aspects of legislation and relevant codes of practice regulating the promotion of medicines;
• Experience within Oncology and/or Rare Disease;
• Experience in change management;
• Managerial experience;
• Experience of planning, managing and organizing resources within short/medium timescales within the overall policy framework. A balance of scientific knowledge, analytical & leadership skills and business acumen.

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