Medical Evidence Advisor
5 mesi fa
**Medical Evidence Advisor**
At AstraZeneca, we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve, no matter where you start with us.
Welcome to **MIND (Milan),** one of over 400 sites here at AstraZeneca. The site provides a collaborative environment where everyone feels comfortable and able to be themselves, which is at the core of AstraZeneca’s priorities.
Recent developments in the understanding of respiratory disease pathways mean that we are entering an era of unprecedented potential to deliver scientific breakthroughs and transform the lives of people with respiratory diseases. Our 40-year heritage in respiratory science is just the beginning of our story.
Reporting to the Head of Medical Evidence and Medical Information, the **Medical Evidence Advisor** will be responsible for conduction of local RWE AZ-sponsored studies and management of all operational activities pertaining to support of Externally Sponsored Research projects (ESR) in the Respiratory Biologics & Immunology therapeutic area.
**MAIN DUTIES AND RESPONSIBILITIES**
The role broadly includes the following key components:
- Accountable for the entire Evidence Generation Planning process, ensuring its strategic alignment with the Brand Strategy Plan process;
- Leader of the local evidence cross-functional study team (Med Affairs, Market Access, Marketing) to ensure delivery of Payer and Medical Evidence Generation studies;
- Accountable for coordination and management of RWE AZ-Sponsored studies (including primary and secondary data studies) with External Providers (CRO or database/registry holder);
- Primary point of contact between the Company and the Investigator for ESR (externally sponsored research), Coordinate all internal project review & governance processes for ESR approval and guarantee delivery according to approved budget and timelines;
- Develop and maintain contacts with relevant Medical and Payer external stakeholders: KEEs, Scientific Societies, Pharmaco-epidemiologist, etc ;
- Accountable for local implementation of Global-led or Region-led RWE umbrella programs;
- Writing of relevant sections of Study Design Concepts, Study Protocols, Case Report Forms, Study Reports and Manuscripts for Publications
- Communication and collaboration with the Global & Regional counterparts, experts, and stake holders
- Write and negotiate Agreements with service providers and others as applicable.
- Facilitate study drug supply and ensure patient safety reporting, as applicable, in ESR projects
- Training of interns and new-in-role-colleagues on Medical Evidence delivery processes and SOPs (ESRs, AZ-sponsored studies, Primary & Secondary data studies; database studies, AZ publication procedures);
- Acting as the Local Publication Coordinator within the Respiratory Biologics & Immunology therapeutic area;
- Execution of all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes;
- Management of all activities and Account relationship according with Company Values, Code of Conduct, Guidelines/Internal procedures and Italian legislation.
**ESSENTIAL REQUIREMENTS**
- Medical Degree or Scientific Degree and PhD in a relevant TAs
- Fundamental knowledge of basic research, drug discovery, drug development, clinical environment
- Previous experience in clinical research and as Clinical Project Leader or Clinical Trial Coordinator or Study Physician in pharmaceutical industry, health care or research environment.
- Relevant experience (at least 3/5 years) in a pharmaceutical industry
- Excellent knowledge of Clinical Research legislation in particular for observational study and no -profit study
- Proficiency in spoken English and Italian
- Good knowledge of Microsoft Office (especially Excel and Power Point)
- Project Management Leadership
- Communication and public speaking skills
- Goal oriented
- Team working and cross-functional capabilities
- Networking with internal and external stakeholders
**DESIRABLE REQUIREMENTS**
- Master’s degree or equivalent in science/healthcare related field
- Qualified Doctor or qualify epidemiologist
- Experience in epidemiology and data analytics
- An active interest in pursuing continuing education within the Pharmaceutical Industry
- Experience in digital health and digital technologies in clinical research
- Previous experience in Real world evidence studies
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while
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