Within the italian MC, reporting to the Oncology Medical Evidence and Medical Excellence Head, the Junior Medical Evidence Advisor leads the identification of RWE needs and gaps in evidence base; locally, across therapeutical area, and in alignment with Regional/ Global needs. This is accomplished by close collaboration/integration with local cross-functional brand teams in order to ensure the evidence strategy is in-line with brand strategy.
The strategic and proactive identification of relevant evidence will enable more effective and timely responses to requests by external customers.
The Junior Medical Evidence Advisor is responsible for extensive knowledge of databases available to provide relevant information/evidence to satisfy customer needs and will build strategic relationship with partners and Third Party vendors of external data sources, ensuring information governance and data protection is in-place.
The Junior Medical Evidence Advisor works cross-functionally to contribute to the Externally Sponsored Research (ESR) , also called NO-Profit studies, in alignment with AZ strategy, governance processes and standard operation procedures for the relevant therapeutic area.
The role broadly includes the following key components:
- Be the RWE point person for the identification of RWE research required within the Holistic Evidence Strategy for prioritised Brands to secure, maintain or grow market access and to increase scientific knowledge answering external customer and internal business partner needs
- Develop specific RWE research programs for compounds/products across the lifecycle, to influence and support appropriate access for AZ products, and prepare for prioritization.
- Ensures quality and performance standards for research projects are realistic and attained, and studies are conducted in conformance with the Principles of Medical Research.
- Bridge medical, market access and commercial agenda, by establishing and developing Evidence requirements, ideas, and activities to yield robust value evidence and develop value propositions
- Demonstrates understanding of the cross-functional nature of drug development and post-marketing support to inform product-specific RWE strategy.
- Project/Programme Management, including budget and resource management, in evidence generation with Medical and Payer perspectives
- Assess feasibility of study proposals - both Externally Sponsored Researchs (ESR) as well as AZ Sponsored observational researchs
- Coordinate all internal project review & governance processes for internal AstraZeneca initiatives as well as ESR proposals
- Communication and collaboration with the Global & Regional counterparts, experts, and stake holders
- Data access and collection in RWE studies
- Quality assurance in Evidence Generation Studies
- Have technical expertise and research methodological understanding to include statistical analysis, economic models, clinical trials, patient surveys, observational/epidemiologic research, and health technology or other outcome assessment.
- Writing of relevant sections of Study Design Concepts, Study Protocols, Case Report Forms, Study Reports and Manuscripts for Publications
- Effectively communicates health outcomes information to internal business partners, the scientific community, and customers. Leads dissemination of health outcomes information in appropriate scientific venues via development, preparation, and presentation of abstracts, posters, and manuscripts.
- Ethical applications and interaction with Authorities and registry holders (e g National Boards of Health and Welfare regarding use of health care data/registries)
- Study registration in applicable systems and result posting according to Transparency policy
- Write and negotiate Agreements with scientific consultants, investigators, service providers and others as applicable
- Initiate and follow-up collaboration with external investigators, clinicians, payers, consulting companies, external service providers and other organizations
- Facilitate study drug supply and ensure patient safety reporting, as applicable, in ESR projects
- Collaboration and interaction with AstraZeneca other MCs, Regional & Global Medical Affairs, R&D etc regarding Evidence activities
- Contributes to the responses for access issues associated with pricing, reimbursement, and access initiatives through appropriate application of disease state knowledge and research methods in conjunction with Market Access.
- Assure correct quality in accordance with written procedures and current legal requirements and internal standards
- Manage all activities and Account relationship according with Company Values, Code of Conduct, Guidelines/Internal procedures, and Italian legislation
Education, qualifications, skills and experience
- Medical Degree or Scientific Degree and PhD in a relevant TAs
- Fundamental knowledge of basic research, drug discovery, drug development, clinical environment (e.g., economics, epidemiology, health administration, health services, Pharmacoeconomics, statistics, or other relevant sciences)
- Previous experience in clinical research
- Knowledge of Clinical Research legislation
- Knowledge and experience of local health care systems and language as appropriate for the position requirements.
- Proficiency in spoken English
- Good knowledge of Microsoft Office (especially Excel and Power Point)
- Demonstrated Project Management skills
- Project Management Leadership
- Communication and public speaking skills
- Goal oriented
- Team working and cross-functional capabilities
- Networking with internal and external stakeholders
Desirable
- Master’s degree or equivalent in science/healthcare related field
- Qualified Doctor
- An active interest in pursuing continuing education within the Pharmaceutical Industry
- Experience in a pharmaceutical industry
- Excellent knowledge of AstraZeneca policies, procedures, and guidelines
