Drug Supply Manager Not right for you? We've got others

Salary:
Confidential
Location:
Palm Beach Gardens, FL
Posted:
January 13th 2021
Relocation Assistance:
Available
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Drug Supply Manager for Biotech
Remote work - ideally from East Coast

Really important would be someone that had prepared and gone through an inspection (FDA readiness)

The Senior Manager Clinical Supply is a key contributor to achieve our clinical and corporate goals. The Sr Manager collaborates with stake holders in developing the clinical plans, managing activities to deliver clinical trial supply including budgets to support the drug development process. In this role, you will cooperate with internal and external customers and partners in compliance with regulations, internal procedures and GxP requirements. You are a key leader in delivering complex studies, IVRS and critical functions such as packaging, developing label strategies and defining the logistics strategy for your global trial. This position will closely interface with Clinical Operations, Quality, Product Development, Regulatory Affairs, Contract Manufacturing Operations (CMO’s), and Contract Research Operations (CRO’s) to ensure Clinical material is available as required to achieve clinical trial strategy and timelines. This position interacts directly with clinical sites concerning clinical trial material administered at site or at patient’s homes.

In addition, the Senior Manager will face complex problems related to clinical trial supply and will be required to negotiate on timelines and activities with external and internal entities to ensure supply is available for patients. The Senior Manager will continuously track progress towards objectives and advise management of any issues impacting project timelines and provide solutions to the problems. Responsible for actively managing all Quality Systems related to the Clinical Supply Chain including deviations, investigations, CAPA’s, and Change Control.

Principal Responsibilities

Qualifications

Education

 

 


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