Allergan Project Specialist, Clinical Packaging in Jersey City, New Jersey
Project Specialist, Clinical Packaging
Jersey City, New Jersey, United States at http://agn.referrals.selectminds.com/jobs/664/other-jobs-matching/location-only
Sep 27, 2016Post Date
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
Our success is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
Join one of the world’s fastest growing pharmaceutical companies!
At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.
The Project Specialist, Clinical Packaging 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 labeling contracts, and forecasting and ordering supplies. He/she 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.
Main Areas of Responsibilities
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.
Represent the Clinical Supply Packaging Group at team/R&D meetings to update and forecast the status of projects
Manage approval process of labels required to complete packaging according to Medical, Regulatory and FDA requirements
Monitor the shipping and returns of clinical trial materials to and from investigational sites
Create reports and documents to facilitate and record every aspect of all operations performed or projected
Independent and effective coordination of supply requirements for local and international studies, comprising 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.
The following listed requirements need to be met at a minimum level to be considered for the job:
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
Bachelor's Degree required.