Manager Clinical Supply
Primary Duties: Under the direction of the Director, Clinical Supply, the Manager, Clinical Supply manages all drug products and devices; packaging, labeling, Shipment and drug return logistical activities by interacting with both internal and external customers and suppliers in order to accomplish project objectives; develops IMP distribution and return drug plans and manages Clinical Supplies Documentation Systems content.
The Manager, Clinical Supply also monitors inventory levels and provides feedback to Clinical Project Manager regarding expiry and re-supply, if required and leads or participates in Clinical Supplies group developmental initiatives.
60%: Develops and implements IMP supply strategy with Clinical and Medical project managers and contract provider. Monitors set-up with contractors, monitors progress, and when issues arise, work to implement corrective action. Coordinates periodic vendor meetings and business review. Works with internal and external customers to develop and implement IMP return drug management activities. Monitors conformance and troubleshoots when required. Assists in development of IVRS supply and return strategy and participates in User Acceptance Testing related to IMP.
30%: Manages Clinical Supplies IMP project files ensuring inclusion of essential documentation and archiving of interim working notes. Coordinates pre-audit/inspection review. Manages Clinical Supplies inventory for projects assigned by interfacing with contractor to ensure that inventory systems are kept up-to-date and that final product reconciliation is accurately completed.
10%: Leads or participates in global supply or return process-improvement initiatives, developing rational and creating implementation plans for change. Represents Clinical Supplies & Global Logistics for global R&D or other company process improvement initiatives.
Education and Experience Requirements:
* BA/BS Degree: Business or Technical Degree preferred
* 7 years of Supply Chain (Global Logistics, Packaging and Labelling) with responsibility of logistics and distribution with third parties in management role within the pharmaceutical and/ or biotech industries in cGMP and cGDP environment(s).
Key Skills, Abilities, and Competencies:
Excellent communication and organizational skills. Ability to bring diverse groups together to develop IMP supplies and return plans. Troubleshoots supply and return issues in-progress, proposes corrective action for implementation, and monitors conformance. Other Job Requirements: Position will require travel domestically and internationally Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives
As an Equal Opportunity and Affirmative Action Employer, Shire is committed to a diverse workforce. US Applicants who require accommodation in the job application process may contact 484-595-8400.