Location: Madison, NJ
Bill : $94.43 HR
Independently coordinates clinical supply activities for clinical studies in support of development programs. These activities include review of clinical study protocols, design of clinical labels, preparation of packaging and labelling contracts, and forecasting and ordering supplies. Must coordinate the efforts of Clinical Trial Supplies Packaging with Clinical Supplies Manufacturing, Clinical Research, Pharmaceutical Development, Quality Assurance, and Regulatory Affairs with the objective of establishing a plan to have clinical supplies available within the agreed time frame.
The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures.
Key Duties / Responsibilities
Develops and implements the initial timeline budget, drug supply forecasts and component requirements needed for preparation of the Clinical Supply Master Plan for Phase I through IV clinical protocols Oversight: No oversight
Effectively organizes and conducts meetings, and demonstrates facilitation and listening skills
Consistently demonstrates skills for evaluating customer needs and offering alternatives to accomplish project goals
Represent GCSM at CMC/Clinical meetings to update and forecast the status of projects
Reviews Clinical Research Development programs and coordinates development of yearly clinical supplies forecasts and supply plans
Protocol interpretation and breakdown
Demonstrates planning, project management, negotiation and presentation skills
Monitor IP for duration of study and ensuring appropriate stock levels are available for study requirements. Continue to monitor budget, depots and monitor IRT after study start. Ensure IP reconciliation is completed.
Works on routine assignments, and applies knowledge and experience in learning new procedures
Report and Protocol Writing: Create reports and documents to facilitate and record every aspect of the operations performed or projected
Effective coordination of supply requirements for local and international studies, including continuous forecasting, communicating manufacturing needs, and scheduling of packaging/labelling activities
Demonstrates a comprehensive understanding and knowledge of the Investigational Product Supply Chain
Ability to handle multiple assignments and priorities simultaneously in a fluid environment with time pressures
Demonstrates a comprehensive understanding and is knowledgeable in development of Clinical Supplies IRT requirements for drug supply management
Sound judgement, analytical, problem solving and decision-making skills
Demonstrates a comprehensive understanding and is knowledgeable in regulatory requirements, including GMPs and GCPs
Review and update existing SOPs and identify the need for and assist in the establishment of new departmental procedures
Demonstrates a comprehensive understanding of the drug development process and requirements of IND/NDA submissions
At least 6+ years of Clinical Supply / Clinical Packaging / Project Coordination experience in the pharmaceutical/device industry or CRO
Knowledge cGMPs and relevant FDA Regulations essential
Excellent communication and writing skills
Proficiency in Microsoft Office and Microsoft Project
High level of professionalism
Ability to prioritize, planning and problem-solving
Ability to handle multiple projects and work in a team environment
Ability to operate, with composure and confidence, in a team or matrix environment
Effective influencing skills
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