Company Summary:
An established Biotechnology firm dedicated to discovering, developing, and delivery of life-changing treatments to increase the quality of life for patients. They are currently seeking a driven Clinical Supply Consultant with a strong background in managing Clinical Supply efforts for global phase 3 clinical trials. They are looking to bring someone on the team for an initial 6-month contract.
Responsibilities
* Manage outsourced packaging, labeling and distribution of investigational product (IP), working with CMOs
* Lead contract negotiations with vendors or CMOs
* Manage vendor documentation required for the movement of IP domestically and internationally
* Oversees IRT/IWRS/IXRS system development (URS and UAT) and inventory management
* Reviews protocols, batch records, specifications, reports, regulatory filings, SOP in collaboration with QA & Regulatory teams
* Conduct ongoing support for clinical trials, and coordinate destruction of IP
* Possible travel for packaging and labeling and distribution vendor audits
Qualifications
* BA/BS/MS degree with extensive experience in global phase 2 and 3 clinical supply execution, management/coordination.
* 7+ years of experience in pharmaceutical development areas, specifically in CMC preferred.
* Superior written communication and MS Word and Excel skills
* Working knowledge of ICH guidelines, GCP's, 21CFR and Annex 13 requirements.
* Experience with controlled ambient and cold chain shipments
They are looking to bring someone on the team for an initial 6 months with a high possibility of converting to permanent depending on the quality of work! If you are interested in the Clinical Supply Consultant role, then please don't wait to apply!
