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Clinical Coordinator Drug Product Development -WYETH-USA- Andover, MA
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The Clinical Pharmacy group at Wyeth BioPharma is responsible for the planning, coordination and supply of drug products for global clinical studies. Working with a wide cross-section of functions within Wyeth and external partners, the Clinical Pharmacy group plays a critical role in ensuring the timely supply of study materials to the clinical sites. Clinical Pharmacy works with clinical study teams from first-in-person studies through regulatory approval and post-marketing studies to assess the drug supply requirements for potential worldwide clinical trials. Additionally, Clinical Pharmacy initiates bulk and packaging documents necessary for the preparation of Clinical Trial Material (CTM) and works cross-functionally to ensure the timely delivery of clinical supplies.
Act as a Clinical Pharmacy representative to BioPharma, Chemical and Pharmaceutical Development (CPD), Clinical Research and Development, Regulatory Affairs and others as needed.
Interact with CR&D personnel at study meetings and on an individual basis with other team members to obtain information on the status of ongoing or planned trials. Provide updates to Clinical Project Team (CPT) regarding the status of clinical trial materials. Responsible for ensuring timely preparation, delivery, use, and return of clinical supplies.
Working with Drug Product Development personnel, provide drug information for both clinical and marketed product to Study Teams as required.
