Endo

Manager

• Lead the medical information team
• Ensure compliance and trending of medical information inquiries with company procedures
• Compose and maintain standardized response letters and serve as their business owner
• Independently review and critically evaluate medical/scientific literature on company and competitor pharmaceutical products
• Support medical review of company medical and promotional materials
• Participate on cross-functional product development and support teams
• Provide professional consultation regarding safety, efficacy, and proper product usage
• Support Pharmacovigilance and Product Monitoring activities, including Health Hazard Evaluations and customer letters
• Serve on the Signal Action Committee reviewing safety signals
• Comply with global medical information guidelines, standards, and regulations
• Maintain SOPs for responding to unsolicited global medical information requests
• Collaborate with Legal, Regulatory Affairs, R&D, Engineering, Business Development Leadership, Commercial, Pharmacovigilance, and Customer Service
• Guide and monitor the call center and medical information vendor/CRO, including product labeling and policy adherence
• Perform internal quality assessments and medical review of information provided by company personnel
• Act as medical information subject matter expert during audits and regulatory inspections
• Draft audit and inspection responses and assist with corrective actions
• Prepare and deliver regular and ad-hoc medical information and post-market reports
• Identify performance issues and alert appropriate management
• Identify, hire, train, develop, and manage medical information specialists
• Report to the Product Monitoring and Medical Information Lead
• Manage a team of professional individual contributors

Senior Manager, Global Medical Information

Principal

• Monitor the safety, quality, and efficacy of products marketed and sold by Par Health
• Receive, capture, and evaluate product feedback reports in accordance with FDA and global regulations and guidelines
• Provide technical and clinical information regarding product usage and performance
• Provide global Quality oversight for field alert reports, health hazard evaluations, and recalls
• Initiate and coordinate health hazard evaluations, field actions, and mock recalls
• Answer and triage incoming calls via the automatic call distribution line
• Review and approve customer complaint response letters
• Capture, review, and analyze customer usage reports
• Follow up on post-market customer usage and field service reports
• Evaluate complaints for potential adverse events and forward them to pharmacovigilance
• Collaborate globally on reports received from outside the US
• Conduct trend analyses of safety and efficacy profiles
• Prepare reports on continuing product performance for Quality and other departments
• Identify product performance issues and alert management
• Initiate and coordinate complaint investigations and support medical inquiries
• Ensure compliance with global product quality guidelines, standards, and regulations
• Oversee customer usage experiences, field feedback, product safety reporting, and professional consultation
• Collaborate with Legal, Regulatory Affairs, R&D, Commercial, Pharmacovigilance, Medical Information, Customer Service, and Manufacturing Sites
• Provide clinical and technical support for marketed pharmaceutical products
• Provide product performance expertise on cross-functional project teams
• Participate in product development and support teams
• Support audits and regulatory inspections
• Lead process improvement initiatives
• Train new hires, site personnel, and sales representatives on post-market reporting practices
• Report to the Manager, Product Monitoring
• Maintain frequent communication with customers, manufacturing QA personnel, Medical Information Specialists, and corporate divisions

Principal Product Surveillance Specialist

Compliance

• Conduct first-level reviews of direct customer orders flagged by Company algorithms and recommend release decisions according to SOPs
• Coordinate with Commercial business representatives to gather forecasts and other information for flagged-order decisions
• Review customer forecasts for focus products
• Contact direct customers for due diligence information
• Create and maintain documentation required for DEA suspicious-order reporting under record-retention policy
• Review the Direct Order Dashboard and Company data to detect customer-account patterns
• Track metrics for Suspicious Order Monitoring Team reporting
• Review direct-customer Know Your Customer questionnaires for completeness and thoroughness
• Schedule and participate in customer reviews with CS Compliance staff
• Maintain KYC documents for direct customers according to SOPs
• Evaluate SOP effectiveness, identify process enhancements, and implement change-control documentation
• Assist with media and internet-source reviews to identify downstream customers for investigation
• Facilitate Suspicious Order Monitoring Team meetings and prepare meeting minutes
• Prepare and send DEA notices regarding pharmacy restrictions
• Update pharmacy review files based on due diligence from distributors and third-party consultants
• Update Excel trackers with pertinent information
• Maintain and update the list of distributor terminations

Specialist, Controlled Substances Compliance – Analyst

Supply Chain

• Define the strategy and manage daily activities of Par Health’s supply chain processes
• Own planning for all business segments, external manufacturing, logistics, and the IBP Process
• Manage supply chain operations across approximately 200 products and deploy internally and externally sourced materials across the supply network
• Manage short-term planning, long-term business continuity, and network strategy objectives
• Establish and maintain high customer service levels (UFR/OTIF)
• Facilitate the IBP Process and align financial, operational, and commercial objectives
• Work with Procurement and Quality to establish supplier performance and risk mitigation strategies
• Manage operational inventory, stocking levels, future requirements, cash, and turns
• Manage transportation logistics, trade compliance, and import/export practices
• Lead teamwork, collaboration, coaching, counseling, retention, mentoring, training, talent management, and personal development
• Drive accountability and results through strategy deployment and performance management
• Travel to meetings and plant visits as needed
• Report to the COO and manage multiple direct reports
• Collaborate with senior leaders in R&D, Operations, and Commercial

Executive Director, Supply Chain

Customer Support

• Supervise the Par Health Customer Service team
• Lead day-to-day Customer Service department operations and customer care activities
• Establish and monitor metrics to track key activities and departmental performance
• Research best practices and lead productivity, service, and process improvement efforts
• Assist with value stream maps, continuous improvement plans, and their implementation
• Coordinate activities responding to customer and market needs with Trade Compliance and Commercial Operations
• Monitor and adhere to the departmental budget
• Represent the department in cross-functional meetings with Supply Chain, Finance, IS, Sales, Marketing, Commercial Operations, Quality, and Manufacturing
• Serve as customer advocate, resolve high-level problems, and escalate issues to management
• Enter and maintain customer profile database records and prepare status reports
• Process and adjust returned-goods database records, including orders and credits
• Perform other assigned duties

Senior Manager, Global Medical Information

Principal Product Surveillance Specialist

Specialist, Controlled Substances Compliance – Analyst

Executive Director, Supply Chain

Customer Service Supervisor