Sr Associate Clinical Supply Chain Support Office

Career Category

Supply Chain

Job Description

In this vital role, you will serve as   Sr Associate , supporting the Design and Setup of the Clinical Supply Chain   .

Reporting to the   Manager Clinical Supply Chain - Change Mgt ,   and   directed by the Global Setup Leads,   you will   contribute to the   execution and completion of key deliverables associated with   setup activities of global supply chains for clinical trials, by leading information gathering across stakeholders   such as R&D, Regulatory Affairs, Site Supply Chain and Master data , and task close out .

In close collaboration with   the Global Setup Lead team,   you will ensure reliable, compliant, and right-first-time process execution ,   transparent   status reporting on progress, and   pro-active   identification of risks and mitigation strategies   for closing out deliverables.

The role is accountable for   managing   various deliverables   such as:

Master data requests for   product materials ,   Bill of Materials (BOM) , and study related attributes in SAP .

C reation of the Clinical A rtwork   requests   and   facilitating   prioritization of outstanding   attributes in relation to the request form.

Creation   and maintenance of Product Specification Files, an d Depot Plans.

Roles & Responsibilities

Master Data in ERP (SAP)

Central focus point for ERP (SAP) readiness:

Initiate clinical label material   requests;

Requesting Finished Drug Product Materials, Bill of Materials (BOM), Work Breakdown Structure (WBS) elements, Custom Values and ensures   timely   availability to adhere to overall project timelines

Ensures   setup   of Study Design Tables .

Setup Activities

Coordinate and prioritize   artwork   creation process via initiation and routing of clinical artwork creation request forms,   facilitating   discussions to resolve issues and following up on outstanding queries.

Creates and   maintains   Product Specification File Study throughout the life cycle of the clinical trial

Creates and   maintains   third party depot plans and cross docks to support global study footprint

Reporting

Maintains Metrics for Global Setup lead team

Contributes to monthly Workforce planning cycle

Qualifications

5 Years of experience with Bachelor   degree or equivalent in   logistics , business   administration   or life science.

Typically   relevant working experience, preferably in the biotechnology or pharmaceutical industry,

Typically   relevant working experience in an international and regulated environment

Understanding of fundamentals of   logistics /supply chain principles (especially BOM)

Experience in planning

Experience in project management techniques

Advanced experience in MS Office applications (Word, Excel)

Fluency in English, both in oral and written communication

High quality standards with   regards   to work

Ability to set priorities and   timely   escalation

Preferred requirements

Knowledge of clinical supply chain management

General understanding of regulatory guidelines   impacting   clinical supplies ( i.e.   GxP , International Conference on Harmonization (ICH) guidelines, Clinical Trial Directive)

Experience in using SAP

Excellent communicating and   facilitating   issue resolution skills

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