“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
Day to Day Responsibilities:
- attention to detail skills/ regulatory experience/ FDA
- Communication skills
- Collaboration experience
- Ideal candidate: buiness experience with couple of years. A college degree is quality would be great! GMP background is helpful, not required. Automation, logistics, supply chain background would be great.
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"