“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and puerto rico vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations staff augmentation external workers qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship this company, its operations, or its staff.”                                                        

Top 3 Must Have Skills        
    

• Attention to detail skills/ regulatory experience/ FDA
• Communication skills
• Collaboration experience

Day to Day Responsibilities:        
        

• Perform case review. Support the development and delivery of convention-related training
• material. Select cases for reporting to FDA, EMA and business partners based on detailed
• knowledge of legislation & contractual agreements. Ensure compliance of reporting activities
• with timelines and criteria. Interface with local office staff, CROs and business partners
• for case processing issues as necessary. Provide E2B submission support (nullification,
• redistribution). Address case-related queries from Business Partners.
• Perform antibody re-testing coordination (non-LAO tasks for repeat testing). Provide
• treatment assignments for single case unblinding for regulatory reporting.

"This posting is for Contingent Worker, not an FTE"