1 Year Temporary Contract

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Job Description
- Support the Medical Operations Regulatory Manager in the preparation, negotiation and execution of Clinical Studies Agreements for AbbVie-sponsored clinical studies.
- Provide field support to the study team for clinical study submissions, updates and follow-up:
- Optimize liaison with clinical sites ECs/AOs.
- Retrieve comments/questions from ECs/AOs in a timely manner and ensure AbbVie answers are delivered to the correct contacts.
- Support Med Ops Regulatory Team in Investigators Initiated Studies (IIS) activities and regularly update IIS management systems.
- Support Med Ops Regulatory Team in managing HCP requests and patient resupplies of drug for Compassionate Use (PAA) programs.
- Ensure archiving of essential documents for all activities. Qualifications
- Italian equivalent to Laurea Magistrale in medical/science/legal related topics or equivalent degree.
- Ability to work efficiently in a matrix context.
- Fair knowledge of English (minimum level B1 of CEFR).

Preferred




- Previous professional experience in compassionate uses.
- At least 6 months of experience in regulatory and ethical aspects of clinical research.
- Specialty degree or PhD.

Benefits

Your total reward package at AbbVie will be made up of multiple components, including compensation, well-being and benefits. Full details of our comprehensive package will be shared during the recruitment process. The national collective bargaining agreement applicable to this position is B011 CCNL Chemical-Pharmaceuticals Industry.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled. US & Puerto Rico only – to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7a6qkh