Fresenius Kabi USA

Manager

• Serve as primary liaison for assigned wholesalers, distributors, alternative channel partners, and specialty pharmacy accounts
• Negotiate, implement, and manage distribution, specialty pharmacy, enhanced service, fee-for-service, and data reporting agreements
• Own contract implementation with Finance, Supply Chain, Operations, Legal, Contracting, and Market Access input
• Lead account strategies supporting product launches, product access, product availability, and patient supply
• Build and maintain relationships with customer organizations and internal stakeholder teams
• Ensure customer service through communication, issue resolution, account feedback, in-person visits, and business reviews
• Manage account performance across assigned channel partners
• Conduct quarterly and annual business reviews
• Evaluate channel and specialty pharmacy performance against KPIs, service requirements, access objectives, and business goals
• Lead root cause analysis and remediation of operational, procurement, reporting, data quality, access, and customer service issues
• Prepare and present contract, supply, inventory, account performance, and channel updates to senior leadership and cross-functional teams
• Collaborate with the U.S. sales team to identify potential clients and support new Market Access opportunities
• Partner with global manufacturing, supply chain, operations, finance, contracting, market access strategy, sales, marketing, legal, and other teams
• Manage stakeholder participation to achieve customer, channel, product, and portfolio strategies and goals
• Perform other reasonable work activities assigned by management

Senior Manager, Trade Relations

Compliance

• Own regulatory decision-making and strategy for assigned product lines, projects, regions, or regulatory initiatives involving significant complexity or regulatory risk
• Prepare, author, coordinate, or provide senior technical oversight for U.S. and/or international regulatory submissions, including responses to regulatory agency questions
• Approve regulatory strategies developed by Managers and below
• Represent Regulatory as the senior Regulatory Affairs lead on assigned product/project teams and align worldwide regulatory strategies with business objectives
• Maintain communications within Regulatory and across functions to align technical positions, escalation decisions, and consistent execution
• Provide strategic and technical input for product development, project plans, and business decisions
• Monitor evolving regulatory requirements, assess impacts on assigned products/projects or technologies, and ensure compliance
• Review and approve product labeling and advertising/promotional materials for regulatory compliance
• Support regulatory activities for government tenders/initiatives, including professional certifications if required
• Ensure post-market regulatory compliance, including annual reports, PADERs, PSURs, and PMS/PMCF reports where applicable
• Lead complex Health Authority interactions, including meetings, negotiations, and responses
• Develop and maintain effective relationships with regulatory agencies
• Mentor and train other regulatory team members

Senior Manager, Regulatory Affairs – MedTech

Analyst

• Monitor daily rebate operations and ensure rebates are processed and payments issued within contractual requirements
• Coach, mentor, and train rebate analysts
• Assist with internal and external reports and audits for the Rebates Department
• Open and manage IT tickets to report and resolve technical issues
• Interact with IT to create, redesign, and improve standard management sales reports
• Provide ad hoc reports to management regarding GPO, IHN, and National Account customers
• Administer, track, calculate, and process rebate payments, administrative fees, and compliance program payments in Model N
• Review payments for completeness and accuracy
• Enter rebate programs into Model N and produce customer fee and rebate reports
• Maintain communication with the Rebates Team Lead and Senior Manager regarding department status and issues
• Identify process and system improvement opportunities and resolve or escalate discrepancies
• Maintain up-to-date SOPs and ensure team understanding of rebate processes and policies
• Analyze large data sets and provide management with accurate insights
• Act as subject matter expert for the Model N system
• Support Model N training, problem solving, and departmental expertise
• Conduct trend analysis on payment packages and sales history
• Review, approve, and implement new rebate programs and amendments in Model N
• Analyze and reconcile deductions in SAP
• Reconcile rebate payments daily for accurate wholesaler and GPO payments
• Administer Oncology Rebate Programs for key oncology distributor customers
• Process contract eligibility and perform class-of-trade reviews
• Review and analyze GPO memberships and contract eligibility
• Update and maintain contract files
• Provide contract documentation to internal and external auditors
• File contract documents and prepare files for records retention
• Ensure compliance with Health, Safety, Environment, Energy, and Quality Management Systems

Senior Rebate Analyst

Operations

• Lead, create, and execute the OpEx strategy and roadmap for current and future budget years
• Support the PU Warrendale leadership team in identifying, prioritizing, and delivering operational excellence improvements
• Direct and support site OpEx improvement programs to improve regulatory compliance, cost, and growth of MedTech devices and spare parts
• Own the PU Warrendale improvement roadmap
• Establish and manage the site OpEx team and report weekly achievements
• Lead project teams to deliver against plant EBIT targets using appropriate methodologies
• Coach Lean Six Sigma belts and provide plant-wide technical support for project analysis
• Conduct annual belt training for new hires
• Maintain the plant scorecard of critical performance metrics
• Manage project spending against approved budgets
• Supervise external continuous improvement consultants with the site leadership team
• Partner with Manufacturing, Quality, Operations, Supply Chain, and other plant functions to drive local changes
• Manage OpEx project resources with local site leadership
• Ensure projects use appropriate Lean/Six Sigma methodologies, including DMAIC, process controls, and statistical analyses
• Define and implement financial tracking of OpEx results
• Develop Lean/Six Sigma training and implementation and share best practices
• Achieve goals and report key outputs to plant and regional management
• Ensure compliance with Health, Safety, Environment, Energy, and Quality Management Systems

Senior Manager, Site Operational Excellence

Customer Support

• Manage workflow for all quality-related internal and external inquiries
• Evaluate initial complaints for investigation needs within the Global Complaint Management Workflow (gCMW)
• Capture complaint information and required documentation before closure
• Follow up with customers to collect required information
• Coordinate sample retrieval, return tracking, and follow-ups
• Coordinate product returns with Post Market Quality Assurance and Customer Service
• Evaluate and authorize customer credit when applicable
• Provide customers with complaint receipts, status updates, and final evaluation letters
• Attend product-specific monthly Product Review Meetings and report updates
• Escalate customer and product complaints to the internal commercial team
• Process commercial team requests for data, complaint details, and credit reports
• Provide reports to commercial team members
• Participate in customer meetings
• Escalate customer feedback regarding quality processes
• Collaborate with Post Market Quality Assurance and Quality Engineers on trends, investigations, and process improvements
• Assist with investigations of high-risk complaints
• Ensure compliance with Health, Safety, Environment, Energy, and Quality Management Systems

Product Complaint and Support Representative

• Act as the first point of contact for quality-related MedTech product defects in North America
• Serve as primary contact and support for customers and the Medical Device Commercial Organization regarding quality-related complaints
• Manage workflow for internal and external quality-related inquiries
• Evaluate initial complaints for investigation needs within the Global Complaint Management Workflow (gCMW)
• Capture complaint information and required documentation in gCMW before closure
• Follow up with customers to collect required information under SOPs and regulations
• Coordinate sample retrieval, return tracking, and follow-ups
• Coordinate product returns with Post Market Quality Assurance and Customer Service
• Evaluate and authorize customer credit when applicable
• Provide customers with complaint receipts, status updates, and final evaluation letters
• Attend monthly Product Review Meetings and report updates to the MedTech Commercial Organization
• Escalate complaints and customer feedback to internal commercial and quality teams
• Process requests for complaint details, data, and credit reports
• Provide reports to commercial team members
• Participate in customer meetings as needed
• Collaborate with Post Market Quality Assurance and Quality Engineers on trends, investigations, and process improvements
• Assist with investigations of high-risk complaints
• Ensure compliance with Health, Safety, Environment, Energy, and Quality Management Systems

Scientist

• Serve as operational lead for receiving, assessing, obtaining follow-up, processing, and reporting global adverse drug events
• Conduct peer review in the KabiSafe LSMV database and Global Complaint Management Workflow for Drug Safety Scientists and Data Specialists
• Liaise with the Global Vigilance Medical Manager/PV Physician for medical review and assessment
• Act as Subject Matter Expert for adverse drug event processing and FDA reporting
• Conduct interdepartmental training on adverse event procedures
• Lead planning, development, and maintenance of training materials as needed
• Oversee preparation of Periodic Adverse Drug Experience Reports and individual case safety reports
• Maintain knowledge of regulations, SOPs, guidelines, product labeling, regulatory safety publications, and company product data
• Lead development, implementation, and management of Safety Data Exchange Agreements and perform ADE reconciliation activities as needed
• Lead implementation and monitoring of REMS programs as needed
• Collaborate with Global Vigilance to identify and resolve case-processing compliance issues
• Interact with Quality and Regulatory Departments to resolve safety and quality issues
• Assist in creating and revising department procedures and policies
• Ensure compliance with Health, Safety, Environment, Energy, and Quality Management Systems
• Perform additional tasks and responsibilities as required

Senior Drug Safety Scientist

Full-stack Engineer

• Plan, design, execute, document, and analyze reliability tests for new products and product changes
• Operate within defined processes and procedures in a regulated environment
• Participate in technical reviews and organize data and documentation for assigned projects
• Maintain reliability test equipment and perform regular maintenance
• Record test results and defects in Excel, Jira, or other test databases
• Assist with root cause analysis of field returns and reliability test failures
• Develop and maintain troubleshooting documentation for internal and external customers
• Document, track, and analyze field failure data
• Develop and execute written test protocols, including QALT and Reliability Life Testing
• Develop, fabricate, and qualify reliability test fixtures
• Collaborate with Hardware and Sustaining teams to develop testing processes, tools, and fixtures
• Organize, index, archive, and retrieve test records
• Evaluate results against program goals
• Apply reliability theories, practices, regulations, guidance, and standards to reliability activities and compliance documentation
• Ensure compliance with Health, Safety, Environment, Energy, and Quality Management Systems

Senior Engineer – Medical Device Reliability

Administration

• Configure and maintain the Fresenius Kabi LIMS computer system
• Establish and adhere to standard operating procedures and policies
• Support global validation and maintenance of the core system
• Maintain the LIMS and troubleshoot issues to ensure functionality
• Update and create product entries as needed
• Perform administrative functions such as account management
• Monitor network response times
• Support site validation for North America
• Coordinate cross-functional training and collaboration with Microbiology, QA, Chemistry, Stability, I&D, and IQC groups
• Ensure adherence to LIMS User Requirement Specifications and Design Qualification
• Participate in cGMP inspections and other audits as a company representative
• Coordinate document updates with USP, Product Specification, and MOA changes
• Develop, implement, and maintain LIMS Standard Operating Procedures
• Develop LIMS training modules and oversee end-user training
• Assist other Fresenius Kabi sites with implementation efforts
• Act as the site contact for the FK Global LIMS Administrator

LIMS Administrator

Research Analyst

• Conduct drug container and medical device material evaluations studying extractable/leachable compounds that can partition from device materials into infused or transfused fluids
• Analyze trace organic compounds for medical device materials using chromatography/mass spectrometry
• Conduct elemental analysis for medical device materials using ICP/MS
• Independently generate study designs and protocols, and write and distribute final reports
• Work occasionally with samples including human blood and blood components using procedural controls and personal protective equipment
• Assist the lab team in managing comprehensive chemical evaluation testing capabilities for medical device materials
• Support laboratory daily operations, calibrations, and supplies
• Provide technical input and content for analytical method development and review
• Operate ICP/MS and chromatography instrumentation with mass spectrometry detection as a technical expert
• Review laboratory documentation and results produced by colleagues
• Provide collegial support to fellow scientists
• Support occupational and environmental safety, compliance obligations, and continuous improvement of ISO 14001 and ISO 45001 management systems

Research Scientist

General

• Oversee receipt, quarantine, release, storage, dispensing, transfer, shipment, inventory control, and disposal of raw materials, APIs, excipients, reference standards, RLD materials, and other regulated materials
• Support material lifecycle activities including sampling, testing, inventory management, inter-site transfers, domestic and international shipments, hazardous material transportation, customs clearance, and material availability
• Administer reference standard, reserve sample, and retention sample management programs
• Manage controlled substance inventories, dispensing, reconciliation, recordkeeping, reporting, destruction activities, and physical security controls
• Maintain DEA registrations and state licenses, coordinate regulatory submissions, support inspections and audits, and maintain inspection-ready documentation
• Create, review, implement, and improve procedures, records, training, and operational controls
• Partner with Quality, Regulatory Affairs, Supply Chain, Manufacturing, Legal, Corporate Services, suppliers, laboratories, and regulatory agencies
• Perform additional responsibilities and special projects as assigned

Materials Management, Controlled Substance Specialist

• Evaluate extractable and leachable study designs to meet regional requirements, including USP and ISO 10993
• Perform extractable and leachable testing in a cGMP laboratory environment
• Conduct method development, method validation, and stability testing
• Serve as a subject matter expert in mass spectrometry and extractable/leachable studies
• Operate and troubleshoot GC/MS, HR-LC/MS, and other analytical methods
• Evaluate analytical results and identify trends, exceptions, and interpretations related to chemical characterization, product requirements, and toxicological assessment
• Draft, review, and approve E&L analytical testing protocols and reports
• Perform mass spectral interpretation and unknown compound identification
• Prepare E&L studies and safety assessment summaries for regulatory dossiers
• Communicate strategic focus and project plans to team members
• Communicate project status and hurdles with managers, peers, cross-functional teammates, and non-technical audiences
• Provide technical training to other scientists and train junior scientists
• Lead E&L project activities and manage project milestones
• Write, review, and approve analytical methods, validation protocols and reports, E&L testing reports, SOPs, technical memos, investigation reports, change controls, and regulatory dossier content

Senior Scientist, Extractable & Leachable

Director

• Develop and execute the strategic operating plan for key national accounts
• Manage customer(s)’ business and secure profitable access for Biopharma and Specialty products
• Direct large, stakeholder internal teams
• Create strategies to optimize product revenue and maximize outcomes
• Develop customer initiatives and execute service agreements
• Feed key customer insights to HQ personnel
• Develop long-term strategic customer plans and short-term business plans
• Direct analysis and measurement of key business drivers

Director, Payer National Accounts

• Analyze, plan, design, execute, and document software applications and/or processes within established medical product design controls.
• Design and develop software adhering to product requirements, definitions and/or program goals.
• Apply standard techniques and resolve moderate to high complexity problems/defects, performing root cause and failure analysis.
• Display a solid understanding and ability to apply technical theories/practices utilized by own discipline and other disciplines outside the primary area of expertise to identify coverage of risks, requirements, architectural components, functions, and performance.
• Work with senior leadership to improve software engineering process efficiency.
• Perform code reviews to confirm software implemented to approved designs, specifications and meet quality standards.
• Assist with project timing, tracking progress to program schedule.
• Recognize and identify improvements for software engineering process deficiencies and software development best practices.
• Mentor and guide junior staff, routinely provide advice and assistance to team members regarding routine and unique problems.
• Work with internal and external staff to conduct design, redesign, prototype, and other software engineering activities.
• Author and review software specifications compliant with design control process.
• Develop and maintain technical records and detailed documentation for internal and external stakeholders, following standard practices and good documentation procedures.

Senior Engineer, Software HIT

Marketing Analyst

• Primary lead for administering GPO contracting activities and acts as a liaison for related activities between Sales and Contract Marketing
• Leads GPO and IDN contract sign up process for all products and designated accounts under the commercial area of focus (Pharmaceuticals, Infusion Therapy & Medical Device, or Biosimilars)
• Administers, and maintains all contract set up in Model N system
• Working knowledge of the administration and governance of pricing relationships, membership rosters, and contract eligibility process
• Participates and recommends contract terms for customer agreements
• May directly interface with customer on contract negotiations
• Timely, and efficient confirmation, and validation of contract set up and eligibility within required timelines
• Compiles and maintains product information for bids/RFP’s and RFI’s
• Maintains and provides guidance on all contracting activities, such as bids/RFP’s, terms and conditions, and redlining in collaboration with other functional stakeholders in accordance with department and company policies
• Supports and executes contract strategy and bid responses in cooperation with senior leaders across the commercial organization
• Collaborates with internal functional groups relative to assigned accounts which includes written correspondence, contract updates and maintenance, milestone tracking, billing, and membership
• Proactively tracks, governs, and leads expiring contracts or extension activities
• Provides and ensures accuracy of ad hoc reporting as needed
• Identifies process improvement opportunities, and develops, or enhance tools to assist in the work deliverables
• Uses SAP, Model N, Qlik, CLM, CRM and other databases/tools to obtain, prepare, compile, and analyze information
• Analyzes KPIs to drive improvements in contract marketing process
• Provides support during new product launches by ensuring contract information is up to date
• Completes all training requirements, including all department-specific, compliance training, etc.
• Participates in any and all reasonable work activities as assigned by management

Senior Manager, Trade Relations

Senior Manager, Regulatory Affairs – MedTech

Senior Rebate Analyst

Senior Manager, Site Operational Excellence

Product Complaint and Support Representative

Product Complaint and Support Representative

Senior Drug Safety Scientist

Senior Engineer – Medical Device Reliability

LIMS Administrator

Research Scientist

Materials Management, Controlled Substance Specialist

Senior Scientist, Extractable & Leachable

Director, Payer National Accounts

Senior Engineer, Software HIT

Senior Analyst, Contract Marketing – IV Therapy