(Temporary - 12 Months) Medical Operations Regulatory Junior Analyst
(Temporary - 12 Months) Medical Operations Regulatory Junior Analyst
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Job Description
Key responsibilities:
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 followup 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.
3. For Investigators Initiated Studies support Medical Operations Regulatory Team in relevant IIS activities and for regularly updating the IIS management systems.
4. For Compassionate Uses (PAA programs) support Medical Operations Regulatory Team in managing Health Care Professionals requests and patients resupplies of drug.
5. Ensure archiving of essential documents for all activities above.
Qualifications :
Key Requirements:
- PhD/Masters 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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Fulltime
Employment Type
Full-time
