Sr Associate Clinical Supply Chain Support Office

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

Reporting to theManager Clinical Supply Chain-Change Mgt,anddirected by the Global Setup Leads,you willcontribute to theexecution and completion of key deliverables associated withsetup activities of global supply chains for clinical trials, by leading information gathering across stakeholderssuch as R&D, Regulatory Affairs, Site Supply Chain and Master data, and task close out.

In close collaboration withthe Global Setup Lead team,you will ensure reliable, compliant, and right-first-time process execution,transparentstatus reporting on progress, andpro-activeidentification of risks and mitigation strategiesfor closing out deliverables.

The role is accountable formanagingvarious deliverablessuch as:

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

Creation of the Clinical Artworkrequestsandfacilitatingprioritization of outstandingattributes in relation to the request form.

Creationand maintenance of Product Specification Files, and Depot Plans.

Roles & Responsibilities

Master Data in ERP (SAP)

• Central focus point for ERP (SAP) readiness:

• Initiate clinical label materialrequests;

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

• Ensuressetupof Study Design Tables.

Setup Activities

• Coordinate and prioritizeartworkcreation process via initiation and routing of clinical artwork creation request forms,facilitatingdiscussions to resolve issues and following up on outstanding queries. 

• Creates andmaintainsProduct Specification File Study throughout the life cycle of the clinical trial

• Creates andmaintainsthird 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 Bachelordegree or equivalent inlogistics, businessadministrationor life science. 

• Typicallyrelevant working experience, preferably in the biotechnology or pharmaceutical industry, 

• Typicallyrelevant working experience in an international and regulated environment

• Understanding of fundamentals oflogistics/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 withregardsto work

• Ability to set priorities andtimelyescalation

Preferred requirements

• Knowledge of clinical supply chain management

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

• Experience in using SAP

• Excellent communicating andfacilitatingissue resolution skills