Principal Clinical Supplies Management Specialist - Allergan - Irvine, CA

Principal Clinical Supplies Management Specialist - Allergan - Irvine, CA -

Allergan plc (NYSE: AGN) is a daring, international pharmaceutical firm and a pacesetter in a brand new business mannequin – Progress Pharma. Allergan is concentrated on creating, manufacturing and commercializing branded prescription drugs and biologic merchandise for sufferers all over the world.

Allergan markets a portfolio of greatest-in-class merchandise that present novel remedies for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, ladies’s well being, urology, anti-infective and cardiovascular therapeutic classes. With business operations in roughly 100 nations, Allergan is dedicated to working with physicians, healthcare suppliers and sufferers to ship progressive and significant remedies that assist individuals around the globe reside longer, more healthy lives.

Our success is powered by our world-class group’s dedication to being Daring for Life. Collectively, we construct bridges, energy concepts, act quick and drive outcomes for our clients and sufferers around the globe by all the time doing what it’s proper.

Be a part of one of many world’s quickest rising pharmaceutical corporations

!

At Allergan you’ll have the chance to thrive in a quick-paced, strategic surroundings the place daring, progressive considering isn’t simply welcomed, it’s inspired. Throughout all features, we relish the chance to assist our individuals fulfill their potential. Our speedy progress technique means loads of alternatives to step into the highlight.

Place Description

Principal Clinical Supplies Management Specialist independently

coordinates medical provide actions for medical research in help of improvement packages. These actions embrace assessment of medical research protocols, design of medical labels, preparation of packaging and labeling contracts, and forecasting and ordering provides. Should coordinate the efforts of Clinical Trial Supplies Packaging with Clinical Supplies Manufacturing, Clinical Analysis, Pharmaceutical Improvement, High quality Assurance, and Regulatory Affairs with the target of building a plan to have medical provides obtainable inside the agreed time-frame.

Principal Areas of Obligations

Develops and implements the preliminary timeline, price range, drug provide forecasts and element necessities wanted for preparation of the Clinical Supplies Contract and Provide Order for Part I by means of IV medical protocols with minimal supervision.

Participates on and/or leads Clinical Supplies Supply Groups.

Critiques Clinical Analysis Improvement Packages and coordinates improvement of yearly medical provides forecasts.

Protocol Interpretation and breakdown.

Staff Illustration: Symbolize the Clinical Provide Packaging Group at workforce/R&D conferences to replace and forecast the standing of tasks.

Clinical Labeling: Handle approval strategy of labels required to finish packaging in accordance with Medical, Regulatory and FDA necessities.

Delivery and Returns: Monitor the delivery and returns of medical trial supplies to and from investigational websites.

Report and Protocol Writing: Create studies and paperwork to facilitate and document each facet of all operations carried out or projected.

Works independently on routine assignments, and applies information and expertise in studying new procedures.

Unbiased and efficient coordination of provide necessities for native and worldwide research. This consists of forecasting, scheduling of manufacture/packaging/overseas language labeling, storage/delivery/hazardous supplies/export, and information of laws. Interacts successfully with worldwide teams on provide points.

Demonstrates a complete understanding and is educated in regulatory necessities, together with GMPs and GCPs.

Demonstrates a complete understanding and is educated within the improvement of IVRS system necessities for drug provide management.

Demonstrates a complete understanding and is educated within the improvement of Relaxation Of World Depot sourcing for drug provide management.

Demonstrates a complete understanding of the drug improvement course of and necessities of IND/NDA submissions.

Demonstrates information and possesses expertise in a number of medical provides tasks.

Evaluate and replace present SOPs and determine the necessity for and help within the institution of latest departmental procedures.

Persistently demonstrates expertise for evaluating buyer wants and providing options to perform undertaking objectives.

Successfully organizes and conducts conferences, and demonstrates facilitation and listening expertise.

Provides efficient shows to departmental and interdepartmental teams.

Necessities

The next listed necessities have to be met at a minimal degree to be thought-about for the job:

three-5+ years of Clinical Provide / Clinical Packaging / Undertaking Coordination

Information cGMPs and related FDA Laws are important

Wonderful communication and writing expertise

Potential to prioritize, planning and drawback-fixing

Potential to deal with a number of tasks and work in a group surroundings

Excessive degree of professionalism

Schooling

Bachelor’s diploma

EEO/AA M/F/V/D

Requisition ID

:

150700

Main Location

:

CA-Irvine

Job

:

Analysis & Improvement

Job Sort

:

Normal

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