Project Specialist, Clinical Packaging

Job Advertised by Pharmadiversity Job Board - * Develops and implements the initial timeline, budget, drug supply forecasts and component requirements needed for preparation of the Clinical Supplies Contract and Supply Order for Phase I through IV clinical protocols with minimal supervision * Participates on and/or leads Clinical Supplies Delivery Teams * Reviews Clinical Research Development Programs and coordinates development of yearly clinical supplies forecasts. * Protocol Interpretation and breakdown. * Team Representation: Represent the Clinical Supply Packaging Group at team/R&D meetings to update and forecast the status of projects * Clinical Labeling: Manage approval process of labels required to complete packaging according to Medical, Regulatory and FDA requirements * Shipping and Returns: Monitor the shipping and returns of clinical trial materials to and from investigational sites * Report and Protocol Writing: Create reports and documents to facilitate and record every aspect of all operations performed or projected * Works independently on routine assignments, and applies knowledge and experience in learning new procedures. * Independent and effective coordination of supply requirements for local and international studies. This includes forecasting, scheduling of manufacture/packaging/foreign language labeling, storage/shipping/hazardous materials/export, and knowledge of regulations. Interacts effectively with international groups on supply issues. * Demonstrates a comprehensive understanding and is knowledgeable in regulatory requirements, including GMPs and GCPs * Demonstrates a comprehensive understanding and is knowledgeable in the development of IVRS system requirements for drug supply management * Demonstrates a comprehensive understanding and is knowledgeable in the development of Rest Of World Depot sourcing for drug supply management * Demonstrates a comprehensive understanding of the drug development process and requirements of IND/NDA submissions. * Demonstrates knowledge and possesses experience in multiple clinical supplies projects. * Review and update existing SOPs and identify the need for and assist in the establishment of new departmental procedures * Consistently demonstrates skills for evaluating customer needs and offering alternatives to accomplish project goals. * Effectively organizes and conducts meetings, and demonstrates facilitation and listening skills * Gives effective presentations to departmental and interdepartmental groups. * Bachelors Degree with 3-5+ years of Clinical Supply / Clinical Packaging / Project Coordination * Knowledge cGMPs and relevant FDA Regulations essential * Excellent communication and writing skills * High level of professionalism * Ability to prioritize, planning and problem-solving * Ability to handle multiple projects and work in a team environment. br/ br/ * For application attention if web source is requested please use PharmaDiversity or PharmaDiversity Job Board. br/ br/ APPLY FOR THIS JOB by going to ...http://www.pharmadiversityjobboard.com/view_job.php?post_id=570986&tag=aje