Job Description

“This role is currently work-from-home and will move to the office environment after the COVID-19 restrictions are lifted.”

Job Description: Create and maintain supply strategies for all investigational product based on the scientific and regulatory confines of the drug’s development with minimal supervision. Working independently, they will be capable of mentoring others whilst acting as a consultant to others outside of the role.

Responsibilities:
• Collaborates with internal Global Clinical Supply Chain (Client) teams and external Customers and Service Providers, including but not limited to Global Drug Development, Pharmaceutical Development, Product Development Quality (PDQ), External Vendors and Medical to ensure all needs are met.
• Proactively defines, plans, and communicates the clinical supply chain strategy in support of global clinical studies to ensure optimal use and alignment with study and corporate goals. Demonstrates robust knowledge and confidence of Client processes when presenting at cross-functional meetings.
• Responsible for generating and driving strategies for continuous improvement, both departmental and/or inter-departmental.
• Influences clinical and development timelines, study design and country selection. Directly responsible for reviewing and providing input to draft clinical protocols, communicating timelines and investigational product strategies to study and cross-functional teams.
• Develops supply forecasts for complex studies through evaluation of the clinical development plan and protocol analysis. Monitors inventory and analyzes drug utilization versus forecast taking into account country requirements and logistical timelines.
• Issues Manufacturing and Packaging/Labeling requests to Clinical Supply Operations (CSO) in alignment with RDSC Master Planning timelines and based on collaboration with Clinical Development team, Chemistry, Manufacturing & Controls (CMC) team and CSO Packaging and Labeling to ensure package design and clinical label for investigational product meet protocol and regulatory requirements.
• Monitor use date of investigational drug product for assigned protocols. Support use date extension activities, such as generation of Use Date Extension (UDE) memo, and provide feedback to Logistics team to support generation of UDE labels for depots and clinical sites.
• Ensures timely delivery of quality clinical supplies for all assigned compounds and protocols by collaborating with internal and external sources while taking into account country Regulatory and QP Release requirements.
• Participates in development, review and approval of Interactive Response Technology (IRT) specifications. Develops investigational product distribution strategies and maintains distribution and supply strategies at depot and site level according to study and IRT requirements.
• Actively participates in internal Trial Supply Management and Clinical Supply Chain meetings, Study Team meetings, Clinical Supply Matrix Team meetings and any other relevant meetings providing all relevant data and documentation prior to each meeting, highlighting any risks and mitigation strategies.
• Collaborates with Clinical Supply Strategic Sourcing team to procure commercial drug in alignment with country and clinical study requirements. Attends meetings with vendors and generates purchase requisitions as needed. Actively supports the budget process by maintaining supply and demand estimates for assigned studies in Budget Tool and by regularly reviewing and updating against revised clinical plans.
• Acts as the main Clinical Supplies contact person for the assigned compound and associated studies, leading communications regarding global supply strategy with study team as appropriate.
• Supports associated actions stemming from change controls.
• In collaboration with Compliance, prepare eTMF, CSR appendices and batch listings to support inspection readiness activities.
• Enters product complaints and deviations in appropriate system and works with PDQ for investigation and resolution.
• Manages conflicts/issues and leads issue resolution with internal and external partners and customers.
• Writing of departmental procedural documents as applicable.
• Performs other tasks as assigned.

Education and Required Experience:
BA/BS
• Minimum 5+ years Pharma industry related experience.
• Minimum 3 years Clinical Supplies/Development with global experience or equivalent experience.
• An equivalent combination of education and experience may substitute.
• Advanced knowledge of the global drug development process and global regulatory Requirements.
• Advanced analytical skills.
• Advanced communication and negotiation skills.
• Advanced project management skills.
• Advanced knowledge of forecasting and planning and proficient knowledge of related areas i.e., Manufacturing,
Packaging & Labeling, IVRS, Logistics, Quality, Stability, etc.
• Strong knowledge of import / export requirements.
• Strong knowledge of IVRS and CTMS systems.
• Advanced knowledge of industry technology and how to apply source innovative solutions and new industry best
practices.
• Develops and applies unique ideas and new methods to achieve higher performance and excellence.
• Team and individual leadership (leads courageously).
• Oral and written communication (fosters open communication).
• Conflict resolution (manages disagreements).
• Negotiation (Manages Execution, Results Driven, Analysis of Issues, Effective Speaking, Builds Relationships).
• Influencing (manages influencing others).
• Delegating (provides direction).
• Coaching and mentoring (fosters teamwork).
Additional Job Requirements:
None

How to Apply

Job Types: Temporary.

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