Global Clinical Supply Chain

1 week ago

Slough, Slough, United Kingdom Cpl Life Sciences Full time

Role:
Clinical Supply Chain Associate

Duration: 12 x Months (potential perm)

Location:
Uxbridge (Hybrid working)

Rate:
£21.26 per hour


We are working with a very large, Multinational Pharmaceutical company, and they are looking for Supply Chain Associate to join their team for a 12 month contract.

They are looking someone with junior level experience. Will be working as a support role with development opportunities to progress to managing studies.

Position Summary


Create and maintain supply strategies for all investigational product based on the scientific and regulatory confines of the drug's development with mínimal supervision.

Roles and Responsibilities

  • Collaborates with internal Global Clinical Supply Chain (GCSC) teams and external Customers and Service Providers, including but not limited to Global Drug Development, Pharmaceutical Development, Product Development Quality (PDQ), External Vendors andMedical to ensure all needs are met.
  • Proactively defines, plans, and communicates the clinical supply chain strategy in support of global clinical studies to promote optimal use and alignment with study and corporate goals. Demonstrates strong knowledge of GCSC processes when presenting atcrossfunctional meetings.
  • Responsible for identifying and supporting strategies for continuous improvement, both departmental and/or interdepartmental.
  • 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 crossfunctionalteams.
  • Develops supply forecasts for 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 logístical 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 CSOPackaging 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 andclinical 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 studyand 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 processby 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 with internal and external partners and customers.
  • Writing of departmental procedural documents as applicable.
  • Performs other tasks as assigned.

Skills and Qualifications

  • Minimum Pharma industry related experience.
  • Minimum Clinical Supplies/Development with global experience or equivalent experience.
  • An equivalent combination of education and experience may substitute.
  • Moderate / Strong knowledge of the global drug development process and global regulatory requirements.
  • Proficient and strong analytical skills.
  • Strong communication and negotiation skills.
  • Proficient and strong Project management skills.
  • Strong knowledge of Forecasting and Planning and proficient knowledge of related areas, i.e. Manufacturing, Packaging & Labeling, IVRS, Logistics, Quality, Stability, etc.
  • Proficient knowledge of import / export requirements.
  • Proficient/Strong knowledge of IVRS and CTMS systems.
  • Proficient / Strong knowledge of industry technology.
  • Applies and drives Forecasting and Planning activity as it relates to protocol.
  • Ability to build/drive internal team consensus.
  • Translates broad strategies into specific objectives and action plans.
  • Team and individual leadership (leads courageously).
  • Oral and written communication (fosters open communication).
  • Conflict resolution (manages disagreements).

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