- Responsible for managing supplies for dynamic clinical studies associated with multiple clinical development programs across the lifecycle of the programs (Phase 1, 2, 3, Managed Access).
- Leads end –to-end clinical supply responsibilities including but not limited to protocol interpretation, demand planning, supply planning, distribution, inventory management,label generation and planning and execution of labeling operations at partner contract manufacturing organizations (CMOs).
- Works collaboratively with Clinical Operations, Formulation Process Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory, Outsourced Manufacturing and Project Management partners to develop optimal supply strategies and ensure on time delivery of clinical supplies to initiate and resupply studies with investigational medicinal product (IMP).
- Partners with Quality Assurance to resolve quality-related issues with labels/labeling/distribution vendors in a timely manner and develops holistic corrective actions to prevent recurrence.
- Partner with Regulatory to ensure labels meet global regulatory requirements and filings accurately reflect the global supply chains.
- Oversees labeling/distribution contractor activities and relationships and participates in vendor selection, onboarding, management, issue resolution and continuous improvement.
- Actively participates in and supports continuous improvements programs, processes and systems.
- Stays current with industry trends and best practices with respect to clinical supply management as well as changes in the regulatory landscape that would impact clinical supply chain.
- Authors and reviews SOPs and labeling batch records required for distribution and clinical labeling activities to ensure GMP compliance.
- Prepares and/or approves purchase orders and supports the budgeting process.
- Examines functional issues from a broader organization perspective and supports day to day operation activities as needed
- Excellent verbal, written, and interpersonal communication skills.
- Strong computer and organizational skills. Project management experience.
- Able to anticipate client obstacles and difficulties and act upon this to meet goals.
- Ability to write clear, concise, and error-free documents.
- Ability to exercise judgment within defined procedures and policies to determine and take appropriate action.
- Possess a strong knowledge of the FDA, cGMP, and GCP standards as well as regulatory guidance documents such as Annex 13.
- Possess clinical supplies experience/knowledge in forecasting, demand / supply planning, IRT systems, inventory management, clinical labeling and distribution including cold chain, import/export, and reverse logistics.
- Possess strong collaboration, influencing and negotiation skills to work effectively with internal cross-functional groups and external suppliers to meet the aggressive clinical study timeline and patient needs.
- Works well with ambiguity, can assess options quickly and efficiently and implement best option in alignment with culture and expectations for clinical timelines.
- Requires a Bachelor's degree preferably in a science-related field
- 8+ years of relevant industry experience (preferably in end-to-end clinical supply management including clinical labeling)
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Manager, Supply Chain - Foster City, CA, United States - US Tech Solutions
Description
TypeContractExperience-1Job ResponsibilitiesManager, Supply Chain, is an enthusiastic team player who will provide expertise in a fast-paced pharmaceutical clinical supplies environment for global clinical trials.
The Manager works collaboratively with other members of Client, PDM and DevOps staff to meet project deliverables, solve business problems and create competitive advantage.
This role has great exposure to all elements of the clinical supply chain from the protocol design through manufacturing to the ultimate distribution and inventory management of clinical supplies at the clinical sites worldwide.
Specific Job Requirements:
Knowledge:
Education and Experience:
Required Years of Experience:
[5-8 years progressive experience in Supply Chain within the biotech, pharmaceutical, industry]Required Degree or Certification:
[Bachelor or Master Degree in Business Administration, Operations Management, or similar education required]Top 3 Required Skill Sets:
[Demonstrates knowledge of global clinical trials and the drug development process, Knowledge of IRT system setup and functionality and proficiency with Excel modeling, Strong collaboration and excellent team skills to be successful in cross-functional and multi-cultural teams]Top 3 Nice to Have Skill Sets:
[Experience in deviation investigation and CAPA implementation, Experience in vendor oversight and managing external partnerships and relations, Strong analytical, problem solving, and communication skills]
