Job Description
Our client is looking for a 10+ year Sr. Clinical Operation Manager who can assist with document preparation and organization of the phase III Legacy drug (BLA) that will be submitted to CDER by the end of 2023 potentially early 2024. This person will also be expected to work with a number of legacy studies they need to get in order and send to CROs who will be building the ISS and ISE datasets. Previous BLA and Biologics experience is going to be crucial for this position. Familiarity and working experience within eCTD is going to be crucial working with this submission.
Required Skills
Clinical Operations
Phase III Experience
Biologics
BLA Submissions
Radiopharmaceuticals – PLUS
Remote: Sr. Operations Manager (Biologics) (232463)
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