Senior Clinical Supplies Specialist

Retrophin • San Diego, CA 92140

Posted 2 weeks ago

Job Description

Job Title: SeniorClinical Supplies Specialist

Department: ClinicalOperations

Reports to: Director,Clinical Supplies

Location: SanDiego, CA

JobSummary

The Senior Clinical Supplies Specialist will support activitiesrelated to Clinical Trial Material (Phase 1-4); providing support to theDirector, Clinical Supplies, cooperate with internal and external customers andpartners in compliance with multinational regulations as well as internal proceduresand GxP requirements. Responsible for supporting and/or managing complexstudies requiring Clinical Supplies project management, forecasting, IXRS,distribution, and supply logistics such as packaging/labeling and globaldistribution. This position will interface with Clinical, Project Management,Regulatory, QA, Manufacturing and teams. The Senior Clinical SuppliesSpecialist will work with vendors involved in the planning, distribution,storage and destruction of Clinical trial supplies for Clinical investigationalsites as required.

Responsibilities:

* Reviews and/or provides ClinicalTrials Materials (CTM) supply forecasts based on projected needs of clinical trial study protocols.

* Coordinates supply of CTM, based onstudy and drug forecasts, with Clinical, Manufacturing and Medical projectmanagers, as well as contract distribution partners.

* Works collaboratively with otherdepartments for the creation and approval of product labeling.

* Managelabeling and packaging operations with vendors.

* Supportsthe development, implementation, and maintenance of IXRS systems.

* Processes manual orders for CTM to beshipped by from contractors for all studies operating outside of IXRS automatedsupply systems.

* Maintains clinical supplies inventoryfor assigned projects by interfacing with vendor to ensure that inventorysystems are kept up-to-date and that final product reconciliation is accurate.

* Ensures that key supply projectmilestones are met while maintaining open communication on supply plantimelines with internal and external customers and partners.

Requirements:

* Bachelor's degree in a life science,or related field of study. Equivalentcombination of education and applicable job experience may be considered.

* Minimum 4 years Clinical Operationsexperience including experience with import, export and IATA regulations, aswell as clinical supply and cold chain management.

* Strong understanding of CFR and ICHguidelines, regulations and guidelines governing conduct of clinical studies.

* Strongunderstanding of IXRS systems and generation of URS and UAT documentation.

* Well-organized and detail-orientedwith strong technical skills, solid written and verbal communication skills,and proven ability to multitask.

* Excellent leadership and interpersonalskills with an ability to effectively work within a multidisciplinary team andmanage multiple vendors.

* Self-starter who works with a sense ofurgency and acts as a good team player working with other disciplines.

* Adaptability, flexibility,independence and resourcefulness to roll-up-sleeves in order to thrive in smallcompany environment.

* Abilityto appropriately manage and maintain blinded study information.

* Proficiencyin Microsoft Word, Excel, and Project.

Retrophin,Inc. is an EEO/AA/Veteran/Disability Employer

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