Medical Affairs Senior Manager - Respiratory
Tirana, AL
Short Description
Working with Medical Affairs functions as a medical scientific connection between Dompé and key external stakeholders to facilitate scientific exchange, through the development of strong relationships and provision of insights. Lead the advancement and innovation of our treatments for areas of competence. Manage scientific training and support the medical information activities, lead the implementation of Medical Affairs plans and projects in the therapeutic areas of competence. Interact with business partners regarding scientific contents, activities and projects.
Long Description:
• Ensure the management, in compliance with ethical, deontological and legal rules as well as internal company procedures, in the development of scientific projects (interventional clinical studies, observational and epidemiological studies, supports proposals for independent trials, collaborations with scientific companies, working groups, etc.) that favor the development and innovation of the therapeutic area of reference;
• Manage the conduct of the planned clinical activities, in compliance with current legislation;
• In agreement with the Medical Affairs function, lead the implementation of territorial scientific projects consistent with the management strategies and company guidelines, aimed at improving the therapeutic appropriateness, the correct positioning of the managed products and the knowledge of the related pathologies to the reference therapeutic areas;
• In agreement with the Medical Affairs function, develop presentations and scientific insights in inter-company contexts;
• Collaborate with the Medical Affairs function, in developing relationships with the scientific community;
• Manage the generation of new data and publications in the therapeutic areas of reference;
• Ensure the support of Drug Safety & Regulatory Affairs Department from a scientific medical point of view;
• Ensure supports of the Department in evaluating the corporate scientific materials used so that they are consistent with the scientific evidence and the lines of development of the therapeutic area;
• Coordinate the support of the Marketing Department in the preparation of promotional means, ensuring the correctness and ethics of the scientific information contained therein on the basis of current regulations and in compliance with the deadlines defined;
• Lead and manage the scientific training activities in order to ensure correct and effective scientific information to the External Operational Force, headquarters staff and Partners;
• Supports and collaborates with the Medical Information Service for complex bibliographic searches and answers to medical scientific questions;
• Participates, on the recommendation of the Medical Affairs Director, in moments of scientific updating (conferences or specific events) by providing feedback on the scientific topics covered;
• Has knowledge of the legal, deontological and corporate rules governing the activities of own competence, and acts in compliance with them;
• Supports Drug Safety in the medical evaluation of adverse events and in the medical review of pharmacovigilance documentation.
Education
• Medicine & Surgery Degree or Scientific Degrees: Pharmacy, Biology, Biotechnology or equivalent in Medical Science.
Technical Expertise:
• Knowledge of pharmaceutical italian regulations;
• Ability to use (advanced) the main bibliographic research systems (i.e. PubMed, Embase etc.);
• Fluent English;
• Knowledge of the main productivity and collaboration tools (Google Workspace, MS Office).