Samantha Sutherland Email & Phone Number

Chicago, Il, Us

Chicago, Il, Us

Durham, North Carolina, Us

• Conducted risk assessments of various activities across function areas for pharmaceutical and medical device manufacturers to identify gaps in current processes and provided recommendations for improvements and effective compliance monitoring• Acted in leadership position for Fair Market Value (FMV) service offering with activities including, but not limited to, creating internal work documents and processes, developing and qualifying potential client leads, conducting internal team trainings, leading large global FMV engagements (> $150k+), etc.• Supported several clients in account manager capacity to correct issues and facilitate access to correct individuals and/or departments across IQVIA based on type of request• Acted as career manager and formal mentor for 6 junior team members to assist in navigating the IQVIA organization, provide subject matter expertise support, and help with any other miscellaneous items or issues• Determined global Fair Market Value (FMV) rate structures for Healthcare Professionals (HCPs) and certain non-HCPs performing consulting services (advisory boards, speaker programs, training, ad hoc) for pharmaceutical manufacturers• Presented HCP FMV technology solution to potential clients and assisted technology group with client implementation process• Conducted client training sessions across several regulatory and compliance topic areas including, but not limited to, patient support programs, patient assistance foundations, market access, and FMV• Conducted field force ride-along and speaker program monitoring for pharmaceutical manufacturers to ensure compliance with internal policies, industry standards, and global regulations• Assisted technology team in development of multiple new technology solutions to address client needs across HCP/non-HCP, third party, and clinical FMV

Durham, North Carolina, Us

Worldwide, Oo

Fair Market Valuation:• Assisted pharmaceutical company and external counsel in determining bona fide nature of fee-for-service arrangements with third parties in the distribution channel (wholesale distributors, specialty distributors, pharmacy benefit managers, group purchasing organizations, specialty pharmacies, HUBs, co-pay card, eVoucher, retail pharmacies)• Evaluated “current state” processes, procedures, and documentation to support manufacturer in its efforts to comply with government price reporting obligations and proposed a “future state” process to increase efficiencies• Estimated the Fair Market Value (FMV) of services received within fee-for-service arrangements that satisfied the qualitative prongs of the bona fide service fee test as defined by the Centers for Medicare and Medicaid Services (CMS)• Prepared work process tools (FMV calculators, rate cards, standard request form, standard exceptions form, work instructions, policies and procedures, training manuals) to assist in the identification, review, approval, and documentation of fee-for-service arrangements• Performed FMV assessment of clinical research activities, established processes to enable FMV calculation of investigator sponsored research (ISR) and healthcare economics outcomes research (HEOR) studies, and created work process tools to aid in the newly established procedures (budget standards & questionnaire, evaluation check list, FMV rate cards, work instructions, and budget models)• Determined global FMV rate structures for Healthcare Professionals (HCPs) performing consulting services (advisory boards, speaker programs, training, ad hoc) for pharmaceutical manufacturer• Presented HCP FMV cloud-based solution to potential pharmaceutical clients and assisted technology group with client onboarding process

New York, Ny, Us

Regulatory Compliance:• Conducted risk assessment of sales and marketing functions for a top tier pharmaceutical company to identify gaps in current processes and provided recommendations for improvements and effective compliance monitoring• Executed compliance review of inpatient pharmacies, specialty distributors and coordinating center for product with Risk Evaluation and Mitigation Strategy (REMS) program requirements• Investigated allegations of improper grant approvals for Fortune 500 company and evaluated documents and e-mail correspondence to identify $150k of questionable application approvals• Advised pharmaceutical clients on developing and implementing standard operating procedures to ensure compliance with industry standards and global regulations (PhRMA Code, FDA, OIG)• Examined accounting invoices and corresponding support documentation for global pharmaceutical company to identify inappropriate transactions within key risk areasContract Compliance:• Assessed pharmacy benefit manager drug utilization transactions to ensure data integrity, validated prescription drug formulary status and analyzed rebate payment accuracy against contract terms• Assisted client with various tasks related to a company-wide system implementation resulting from a recent acquisition• Analyzed wholesale distributor data to identify erroneous product pricing components (Average Wholesale Price, Public Health Service, Wholesale Acquisition Cost), verified completeness and accuracy of EDI data sets and provided recommendations for contract and process improvements to pharmaceutical company• Executed inventory analysis at wholesale distribution center to confirm product quantity levels and compliance with manufacturer IMA agreement• Assisted client in prescription drug benefit contract negotiation process with pharmacy benefit manager and advised on industry standard pricing and payment structure components

New York, Ny, Us

Financial Analysis:• Led department of 15 analysts and 5 support staff employees in determining creditworthiness of potential clients and maintained position on firm credit committee with senior management to evaluate substantial accounts• Evaluated and reorganized internal sales offices to increase productivity while providing cost savings of $350k to company• Conducted risk analysis to develop standard metrics and adapted credit criteria to volatile market forces and economic conditions• Analyzed impact of significant global regulatory changes on the firm’s business operations for senior management