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Scientific. Clinical. Software Engineering

Snr Clinical Supplies Management Specialist

Orange County Metro Area, CA

Job Type: Scientific Job Number: JN -032020-26486 Region: Orange County Metro Area

Job Description

Key Duties / Responsibilities

Role: 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

Role: 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

Role: 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

Minimum Requirements

Bachelor s Degree

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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