Clinical Supply Support Specialist Services - FSP

About the role

Clinical Supply Support Specialist positions are available at Parexel FSP. These positions are office-based in Warren, New Jersey.

Responsibilities

• Supply monitoring, assessment and oversight activities (risks, stocking levels, trends)
• Pull relevant data for metrics reporting & maintain metrics
• Process requisitions and ensure timely procurement of comparator drugs & ancillary supplies
• Track and manage comparator documentation updates
• Initiate non-system generated shipments
• Monitor and track comparator drug delivery schedules
• Cookout management and resolution
• Coordinate Depot transfers & site return shipments
• Expected Document List (EDL) creation
• Update comparator IMN (Item Master Number)
• Update and maintain eTMF Document Management per regulatory requirements
• Request QA/QP Releases
• Pack-and-label kit and sequence reconciliation
• Inspection Readiness activities
• IRT management activities, including IRT Alert management and UAT activities
• IP / Ancillary Supplies Compatibility Review
• Receive and triage request, forward to FDG for review
• Perform internet searches and contact manufacturers for information
• Data entry of information into database (ASIST or spreadsheet) and Teams
• Manage CSS Email Inbox
• Manage IRT system access for users for all studies
• Complete EDL, IRR and StiL reviews every 3 months for all studies
• Manage all TMF documentation uploads into VEEVA
• Assist in UAT testing

Requirements

• Bachelor’s degree in a related field with an internship or prior industry work experience.
• Preferred 2+ years of experience in the following fields:
• Clinical Supplies
• QA/Regulatory
• Precision Medicine
• Supply Chain
• Manufacturing
• Procurement
• Or equivalent research/commercial biopharma experience

Qualifications

• None specified

Skills

• Strong organizational skills
• Attention to detail
• Excellent communication and interpersonal skills
• Proficiency in Microsoft Office Suite
• Ability to manage multiple tasks simultaneously

Benefits

• Flexible work schedule
• Professional development opportunities
• Competitive compensation package
• Health insurance benefits
• Employee wellness programs

Pay

• TBD

Schedule

• TBD

Company Information

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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