Company Description
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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description

KEY REQUIREMENTS:

• PhD/Master’s Degree in medical/science related topics or equivalent degree.
• At least 6 months of previous experience in regulatory and ethical aspects pertaining to clinical research.
• Good knowledge of English language written and oral.
• Ability to work efficiently in a matrix context.
• A previous professional experience in compassionate uses would be a plus.
  Additional Information
  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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
  US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
  https://www.abbvie.com/join-us/reasonable-accommodations.htm

1. For AbbVie sponsored clinical studies, support the Medical Operations Regulatory Manager in preparation of negotiation and execution of Clinical Studies Agreements and in the relevant interactions with AbbVie Departments and external interactions with Administration Offices (AOs) at Public and Private Institutions.

2. For AbbVie sponsored clinical studies, 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.

1. For Investigator’s Initiated Studies support Medical Operations Regulatory Team in relevant IIS activities and for regularly updating the IIS management systems.
2. For Compassionate Uses (PAA programs), support Medical Operations Regulatory Team in managing Health Care Professionals requests and patients resupplies of drug.
3. Ensure archiving of essential documents for all activities above.
   Qualifications