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

IND1