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Clinical Supplies Lead job in Fort Worth

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Novartis Pharmaceuticals jobs
Texas (TX), Fort Worth
Job Code:  249726BR
Employer:  Novartis Pharmaceuticals
Category:  Operations
Job Type:  Full Time

Location
Country:  United States
State:  Texas (TX)
City:  Fort Worth
Map: 
09/12/2018

Description
The Clinical Supplies Lead in Clinical Supplies Management is responsible for overseeing the clinical supplies for assigned studies within the Medical Device portfolio. The Clinical Supplies Lead secures the supply for assigned clinical trials within the portfolio through planning, inventory, distribution and optimized risk management.

• Oversees all aspects of clinical supplies management ensuring there are sufficient supply levels at sites and depots.
• Represents clinical supplies function at clinical trial team meetings; communicates plan and timelines to internal and external customers and partners.
• Reviews clinical trial protocol and provides input to clinical supplies and IRT sections.
• Creates forecasts and packaging design based on study needs to ensure optimized supply plan in terms of cost, feasibility and overage.
• Proactively drives the labeling, packaging, release, distribution and return of clinical supplies for assigned studies, ensuring the project timeline is met or exceeded.
• Participates in cross functional teams and provides guidance on best practices for clinical supplies management.
• Leads process improvement initiatives and training efforts as a clinical supplies SME.
• Supports internal/external inspections and audits.
• Maintains required documents in a manner consistent with cGMP, 21 CFR Part 11, Annex 13 as well as internal QM, Corporate and Functional level SOPs.The Clinical Supplies Lead in Clinical Supplies Management is responsible for overseeing the clinical supplies for assigned studies within the Medical Device portfolio. The Clinical Supplies Lead secures the supply for assigned clinical trials within the portfolio through planning, inventory, distribution and optimized risk management.
• Represents clinical supplies function at clinical trial team meetings; communicates plan and timelines to internal and external customers and partners.
• Oversees all aspects of clinical supplies management ensuring there are sufficient supply levels at sites and depots.
• Represents clinical supplies function at clinical trial team meetings; communicates plan and timelines to internal and external customers and partners.
• Reviews clinical trial protocol and provides input to clinical supplies and IRT sections.
• Creates forecasts and packaging design based on study needs to ensure optimized supply plan in terms of cost, feasibility and overage.
• Proactively drives the labeling, packaging, release, distribution and return of clinical supplies for assigned studies, ensuring the project timeline is met or exceeded.
• Participates in cross functional teams and provides guidance on best practices for clinical supplies management.
• Leads process improvement initiatives and training efforts as a clinical supplies SME.
• Supports internal/external inspections and audits.
• Maintains required documents in a manner consistent with cGMP, 21 CFR Part 11, Annex 13 as well as internal QM, Corporate and Functional level SOPs.
Minimum Requirements
• Bachelor's Degree or equivalent years of directly related experience (high school +10 yrs; Assoc.+6 yrs; M.S.+2 yrs)
• The ability to fluently read, write, understand and communicate in English
• 2+ Years of Relevant Experience
• Project management and process improvement experience (PMP certification is preferred)
• Knowledge of cGMP, 21 CFR Part 11, and Annex 13 requirements
• Knowledge and use of Interactive Response Technology
• Proven leadership behaviors and strong communication skills
• 2+ years of experience managing clinical supplies is preferred
• Medical Device experience is preferred
ref: (249726BR)
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