Job Description CORE JOB RESPONSIBILITIES To warrant the medical know-how of the Affiliate regarding Rheumatology therapeutic area (including AbbVie products, competitors and general knowledge of specific diseases).
To drive Medical activities to support the Brand Strategy and integrate it into the Brand Plan To represent the Italian Affiliate in the relevant therapeutic Corporate Medical Development setting.
To prepare the medical plan of activities for each product of the relevant area, on an annual basis and to update it as appropriate.
To contribute to the design and improvement of AbbVie Medical Department Italy (AMDI) systems and processes (e.g.
AMDI SOPs and Guidelines) with the aim of ensuring best practice as well as compliance to all applicable regulations and Company procedures.
To undergo training relevant to the function and to be familiar and updated with the AbbVie local and international procedures relevant to the Job Description.
ADDITIONAL RESPONSIBILITIES Responsibilities include but are not limited to the following: To manage the budget of the relevant therapeutic area (including local clinical studies) as approved in the medical plan.
To be responsible for: the design of local AMDI clinical studies.
the review, approval, fulfillment of contract agreements of Investigator Initiated Studies (IISs). To foster the participation of the Affiliate to International clinical trials and provide the Head Medical Affairs/Affiliate Medical Director and Research and Development with appropriate comments regarding the design and implementation of International protocols.
To identify potential sites for carrying out International and local clinical studies and maintain a liaison with them throughout the study conduct in cooperation with Clinical Research Department.
To maintain a continuous relationship with Key thought Leaders and External Expert as to the relevant therapeutic area.
To address queries by physicians regarding the relevant products (including medical support on marketed products to the Pharmacovigilance Unit).
To design or participate to the design of AbbVie events (e.g.
Satellite Symposia), warranting an appropriate medical support to the Commercial Divisions and in agreement with the International and local SOPs.
To provide medical-scientific update on TA, products and competitors, as agreed with the Commercial Divisions and to provide medical training when requested/necessary.
To review promotional material before the approval of the Head Scientific Service, warranting the appropriateness of its medical content and the independence of assessment.
To review the Summary of Product Characteristics and Insert Leaflets, prepared by Regulatory Affairs, before final approval of the Head Scientific Service, as to products of the relevant therapeutic area.
To support the Scientific Training Specialist(s) of the relevant Medical Affairs Unit in preparing the annual scientific training plan for the sales force and its delivery, including the preparation of product handbook(s).
To provide medical support to the Pharmacovigilance Unit as to AEs reported in clinical trials on the relevant products.
Qualifications IDEAL CANDIDATE: Required: Medical (highly preferred), or Italian equivalent to Laurea Magistrale in life science/chemistry related topics.
Minimum of 3 years' working experience in clinical context or in pharmaceutical/biotechnological industry, in a scientific/medical role, within cross functional teams Ability to transform strategies into feasible and realistic actions Ability in leading, motivating, and coordinating cross functional team Excellent knowledge of the health sector and of its development Effective management of the work in a matrix structure Knowledge of financial principles and processes Fluency in written and oral English (Minimum Common European Framework Level: C1).
Preferred: Medical Specialization in Rheumatology Proven success in pharmaceutical/biotechnological context Additional Information AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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