Remote EST or CST: Sr. Operations Manager (Biologics) (232463)

Clinical Research & Clinical Affairs | Life Sciences & Technology
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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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About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
Location
Remote

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