Head of Medical Evidence and Medical Information

6 mesi fa

Milano, Italia AstraZeneca A tempo pieno

**Head of Medical Evidence and Medical Information**:
At AstraZeneca, we believe in the potential of our people and you’ll develop beyond what you thought possible. At AstraZeneca every one of our employees makes a difference to patient lives every day.

**About the Role**

We are seeking an accomplished and highly qualified individual to join our team as the Head of Medical Evidence and Medical Information. In this pivotal role, you will be accountable for the activities and quality within Externally Sponsored Research and Local AZ Evidence Generation studies for BBU. You will provide strategic direction, scientific leadership, and expertise to the Evidence Generation area, while also overseeing the Medical Information department.

**Key Responsibilities**:

- Plan and deliver local Real-World Evidence (RWE) studies and Externally Sponsored Studies (ESR) in compliance with AZ SOP and local regulations, including coordination of internal approval governance for Evidence generation studies.
- Manage and provide leadership to the Medical Evidence BBU team and Medical Information team.
- Generate a local annual Evidence Plan in line with local evidence gaps to support all brands in BBU and according to new launches.
- Collaborate with cross-functional teams (including Market Access, Medical Affairs, and Marketing) to support local brand strategy and medical plan development.
- Provide guidance on innovative projects utilizing Real-World Data (RWD) in the Digital Health field and lead Medical Innovative and digital projects if necessary.
- Support the Regional Evidence plan by working with the Regional team and Evidence Regional team.
- Act as the main contact for Global colleagues for local BBU evidence generation activities.
- Select and manage Local Contract Research Organizations (CROs) and external providers.
- Collaborate with external researchers in hospitals, universities, or research associations to develop outcomes research.
- Coordinate drug supply for local studies (Investigational Medicinal Product or commercial drug).
- Ensure compliance with AZ evidence generation and Med Info systems update and compliance.
- Provide training and guidance to BBU about Evidence Generation and RWE.
- Coordinate the local publication approval process and publication tracking.
- Oversee all Medical Information activities performed by the Med Info team.
- Work with the local GXP team and Quality Evidence Director EUCAN to assure compliance with Good Clinical Practice (GCP), Good pharmacoepidemiologic practise (GPP), and Evidence Quality Manual.
- Perform all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations, and industry codes.

**Education, Qualifications, Skills and Experience**:
**Essential**:

- Bachelor's degree in a science/healthcare related field
- Extensive clinical research background and Real-World Evidence (RWE)
- Substantial experience in a hospital, pharmaceutical, clinical research position, or other healthcare related field
- Working knowledge of relevant regulations with regards to Clinical Research and Observational research
- Broad competence with medical, therapeutic area, and technical terminology

**Desirable**:

- Master's degree or equivalent in a science/healthcare related field
- Excellent knowledge of local decree on clinical research and guidelines
- An active interest in pursuing continuing education within the Pharmaceutical Industry
- Strong Project management experience
- Experience managing a team

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