1 Year Temporary Contract - Medical Operations Regulatory Junior Analyst
Full time
AbbVie
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.
Job Description
- For AbbVie sponsored clinical studies, to support the Medical Operations Regulatory Manager in preparation, negotiation and execution of Clinical Studies Agreements and in the relevant interaction with AbbVie Departments and external interaction with Administration Offices (AOs) at Public and Private Institutions.
- For AbbVie sponsored clinical studies, to provide field support to the study Team for clinical studies submission/updates and follow-up, such as:
- optimizing liaison with clinical sites ECs/ AOs
- retrieving comments/questions from ECs/AOs in a timely manner and ensuring AbbVie answers are delivered to the right contact
- For Investigator’s Initiated Studies to support Med Ops Regulatory Team in relevant IIS activities and for regularly updating the IIS management systems.
- For Compassionate Uses (PAA programs), to support Med Ops Regulatory Team in managing HCP requests and patients resupplies of drug.
- To ensure archiving of essential documents for all activities above.
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 language written and oral .( Minimum level Common European Framework: B1)
Preferred:
- Previous professional experience in compassionate uses
- At least 6 month in previous experience in regulatory and ethical aspects pertaining to clinical research
- Specialty degree or PhD
Additional Information
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.
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Offerta di lavoro pubblicata 3 giorni fa
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