Opportunities • Frink-Hamlett

Opportunities

Manager - Sample Operations (Temporary/Remote).001

Job Title
Manager - Sample Operations (Temporary/Remote).001
Duration
Description

Global Pharmaceutical company seeks a Manager-Sample Operations. This role is responsible for managing the direct-to-practitioner Controlled Substance Sample Program in the United States. This is a remote, contract role, expected to last one year, with the possibility of extension. The hourly rate is $60. 

​​​Primary Duties:

  • Manage overall sample program which includes leading the coordination of cross-functional weekly program management meetings
  • Responsible for managing Sample Fulfillment vendor to ensure Corporate Business rules are implemented and adhered to
  • Receive all government reportable events from participating vendors and manage escalation with Compliance
  • Responsible for investigating AOC variances, significant losses, loss-in-transits or any for cause audits/investigations and coordinating with appropriate departments to ensure reporting obligations are within the required timeframes, including requirements for the DEA, FDA and applicable state requirements
  • Support Compliance monitoring efforts or third-party vendor audits and pull through any vendor non-conformance (Cross-functional involvement)
  • Responsible for managing and maintaining current SOPs
  • Partner with Compliance to establish/maintain PDMA Monitoring Program
  • Review monitoring reports and identify any PDMA potential gaps and/or risks
  • Provide recommendations for improving PDMA Compliance
  • May be asked to participate in sample related investigations
  • Ensure rules for HCP license verification requirements and eligibility requirements across vendors and/or systems are being appropriately applied
  • Partner with the ESIS team to identify systems that require 21 CFR Part 11, system validation and that documentation is available
  • Ensure vendor is following establish process to prepare and send required federal and state related reports within government established timelines
  • Maintain repository for all federal and state submitted reports
  • Manage the PO/Invoicing for sample fulfillment and shipping vendors
  • Ensure required PDMA training is tracked for completion

Requirements:

  • Bachelor’s degree 
  • 5+ years of pharmaceutical/biotech industry experience
  • 1+ years of Sample Operations or Sample Compliance experience
  • Prior experience with Controlled Substance Sample Program preferred
  • Vendor management experience is a plus
  • Strong knowledge of key laws and regulations impacting the pharmaceutical industry including the PhRMA Code; Prescription Drug Marketing Act (PDMA)
  • Excellent written and verbal communication skills
  • Strong interpersonal and collaboration skills to interface effectively with various cross-functional groups
  • Strong project management skills such as scheduling, planning, and prioritizing several diverse activities, initiatives, and projects from different individuals, groups, or departments
  • Responsive and proactive in addressing government reporting requirements
  • Proficient in the use of technology

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