Clinical Materials Coordinator

Canada, Ontario, Mississauga

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The Clinical Materials Coordinator (CMC) leads the coordination and execution of all procurement activities of drug products and packaging materials for global clinical studies. This includes the coordination of the release of these materials to ensure a timely production of Investigational Medical Products in accordance with international standards and regulatory requirements. Furthermore, the CMC is responsible for all tasks related to clinical demand planning of packaging material.

Main responsibility: Single point of contact to ensure availability of drug products and packaging materials to clinical manufacturing. This contains the following responsibilities:

  • Compile product-specific data and documents for drug products and packaging materials

  • Define, request and continuously update the master data of drug products and packaging materials in SAP-systems

  • Manage purchase orders for Roche development drug products, “Roche-Partner” drug products, Roche commercial drug products and external commercial drug products from internal and external suppliers in various systems   

  • Plan and procure packaging materials in SAP-systems

  • Supplier Relation Management: Manage various drug product- and packaging material suppliers to the Clinical Supply Chain Organization, incl. creating suppliers performance transparency with KPIs and taking applicable actions for continuous improvements

  • Support of warehouse in goods receipt questions

  • Perform virtual goods receipts

  • Request the sampling and sample shipment of drug product and packaging materials

  • Manage the compilation of a GMP- and customs-compliant goods receipt dossier for the QA-release of drug products and packaging materials

  • Request and continuously update GMP- and non-GMP-batch data of drug products and packaging materials in SAP

  • Ensure the on time QA-release or AFM (“Authorization for Further Manufacturing”) of drug products and packaging materials

  • Manage returned drug products and packaging materials

  • Manage the shelf-life extensions of packaging materials

  • Confirm the quantities received to enable accurate cost charging of drug products and packaging materials in the relevant financial systems

  • Drive and lead the issue management for global clinical supply concerning the procurement of drug products and packaging materials as well as the goods receipt of drug product

  • GMP Deviation- and Change Management

  • Actively support GMP-, GCP- and BtM- (narcotic drugs) inspections

  • Actively support the Lean Production System (LPS)

  • Lead and participate in global / local projects to optimize Clinical Supply processes

  • Write and update SOPs and other department documents that support daily business

Collaborations

Within the department:

  • Clinical Demand and Supply Leader (CDSL)

  • Warehouse and packaging facility

  • In Process Control (IPC)

  • Master Data Team

  • Clinical Supply Coordinator (CSC)

  • Global Clinical Distribution Lead (GCDL) and Clinical Distribution Associate (CDA)

  • Shelf-Life Management Team

  • Training and Compliance

  • Clinical Label Coordinator (CLC)

  • Contract Manufacturing Site Managers

Cross-functional with:

  • Procurement

  • Pharmaceutical and analytical R&D functions

  • Commercial Roche sites

  • Commercial warehouses

  • Roche Drug Substance and Drug Product Development sites

  • Quality Assurance (internal and external), Quality control and EU QP’s

  • Global Strategic Resource and Portfolio Management, Accounts Payable & Receivable, Management Accounting

  • Medical Affairs (PDMA)

  • Occupational Hygiene and Group Health Protection

  • Global Packaging Material Development (gPKD)

  • Local Packaging Material Development

  • Device Development

  • Direct Material Specification Lifecycle Team (DMSLT)

  • Supplier Quality Management (SQM)

  • External with various global vendors

Requirements

  • B.A. or B.S. degree with 2+ years work experience in the pharmaceutical, biopharmaceutical or related industry, or a Master’s Degree with 1+ years relevant experience, or an equivalent combination of education and experience.

  • Work experience in supply chain, life science, industrial engineering or equivalent

  • High cultural awareness and social competence required as a cooperation and communication in complex situations with different cultures and countries is part of the daily job.

  • Well organized, high level of planning skills.

  • Demonstrated excellent problem solving and decision making skills.

  • Ability to work independently. Self-motivated, proactive, quick thinking and adaptable. Ability to set priorities and to remain flexible in stressful situations.

  • Customer-focused, ability to create trustful relationships with business partners.

  • Excellent English skills, ideally also German skills.

  • Well-developed teamwork, collaboration and negotiation skills to communicate clearly and professionally both verbally and in writing.

  • Work experience in a GMP environment is beneficial

  • Knowledge of SAP R3, APO knowledge is beneficial.

  • Sound knowledge of Google and Windows office applications.

NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including educational, employment, references and criminal records (for which a pardon has not been granted) checks. 

AGENCY NOTICE: Please note that Roche Canada does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Services Agreement with agency/recruiter, Roche Canada will not consider or agree to payment of any referral compensation or recruiter fee. In the event a recruiter or agency submits a resume or candidate without a previously signed agreement, Roche Canada explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

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Job Level:

Individual contributor