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Alpha Consulting

Senior Clinical Packaging Specialist

Post Date:Apr 21, 2017Type:Contractor
Start Date:4/21/2017Salary:$75.00
Location:US-NJ-Jersey City Job Reference:17-00600

Job Description:

Project Description:
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. 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.
  • 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.

Required Skills:
  • 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.

This 7+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Annie: [Click Here to Email Your Resumé]


Contact Information
Alpha Consulting
Name: Annie Doyle

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