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.
Creation of the Clinical Artwork requests and facilitating prioritization of outstanding attributes in relation to the request form.
Creation and 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
