Snr Clinical Supplies Management Specialist
Edison-New Brunswick Metro Area, NJ
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 company 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
- 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.
- Demonstrates a comprehensive understanding and is knowledgeable in regulatory requirements, including GMPs and GCPs
- 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