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    Health (Contracts)

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  • Negotiation and drafting of specialized pharmaceutical consultant agreements, contracts, documents and templates, such as for: accounting; advertising; academic medical center (AMC;) academic research organization (ARO); architectural services; audit; bio-tech; chemistry, manufacturing and controls (CMC) validation; commercialization strategy; compliance; compliance validation; confidential disclosure agreement (CDA); contract development and manufacturing organization (CDMO); COVID-19 response services; data management; dispensing; distribution (such as: exclusive; full-line; independent; international; limited; local; non-exclusive; regional; simple; specialty; territory); document management; drug development, launch and registration; educational materials FDA compliance reviewer; emergency investigational new drug (EIND) development, launch and registration; engineering services; ethics validation; Federal and state inspection support; FDA compliance; formulation and process development; good manufacturing practices (GMP) validation; group participation organization (GPO); group purchasing organization (GPO); Health Insurance Portability and Accountability Act (HIPAA) compliance; healthcare support services; health care provider (HCP) consulting; hospital merger and acquisition; inspection; integrated delivery network (IDN); investigational new drug (IND) development, launch and registration; life sciences; lobbying; manufacturing process; market level operating; marketing; management; medical devices; medication management; outsourcing; patient experience support; personal data management; pharmaceutical; pharmacist; pharmacy accreditation; pharmacovigilance; preclinical; product design and development; promotional materials FDA compliance reviewer; quality assurance; records retention; regulatory affairs; risk assessment; scientific commercialization; social media; strategic research (SRA); subject matter expert (SME); supplier assessment; supply chain; technical specifications FDA compliance reviewer; vendor selection; operations management support.

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  • Negotiation and drafting of agreements, contracts, documents and templates, such as for: branded products; clinical studies; clinical trials; electronic medical records (EMR) providers; electronic health records (EHR) providers; generic products; life sciences; medical devices; procurement; research and development (R&D); sourcing; supply chain.

 

  • Negotiation and drafting of agreements, contracts, documents and templates for complex outsourcing models such as: biomarker studies; clinical studies; clinical supplies; clinical trials Phases I-IV; companion diagnostic (CDx) tests; contract research organizations (CROs); laboratory engagement; laboratory supplies; R&D; and, other outsourced services. 

 

  • Negotiation and drafting of agreements, contracts, documents and templates, such as for: abbreviated new drug application (ANDA); clinical laboratory (CLA); clinical research (CRA); clinical trials (CTA); confidentiality (CDA); consultant services; cooperative research and development (CRADA); data management; distribution; distributor; healthcare provider (HCP); informed consent (IC); medical writing services; new drug application (NDA); non-compete (NCA); non-disclosure (NDA); non-solicitation (NSA); emergency investigational new drug (EIND) application; investigator-initiated trial (IIT); master (MA); master services (MSA); pharmacy rebates; service level (SLA); service provider (SP); vendor services; wholesale pricing.  

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  • Negotiation and drafting of: conversion of services values into relative value units (RVUs) using Medicare and Medicaid rates; dispute resolution procedures; filing deadlines; notice requirements for nature and scope of covered services, renegotiation, term, termination; payment deadlines; proposed fee schedules of current procedural terminology (CPT) codes and prices; provider contracts; reimbursement rates. 

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  • Negotiation and drafting of agreements, contracts, documents and templates, such as for: clinical support; environmental services; financial services; participating provider agreements (PPAs) (with a carrier or network of a carrier, panel, intermediary or representative); physician services; and, other agreements related to the provision of various healthcare services.

 

  • Managed the contracts management, outsourcing, sourcing and supply chain legal processes, such as: amendments; authoring contract content; bid analysis; change orders; claims; communications with bidders and vendors; contract award; contract budget; contract execution; ensuring that the payment schedules were cash-neutral and aligned with deliverable timelines; qualified vendor selection; requests for information (RFIs); requests for proposals (RFPs); requests for qualifications (RFQs); requests for solicitations (RFSs); requests for solutions (RFSs); request for submittals (RFSs); validation rates proposed by service providers; vendor background checks; vendor qualifications checks; verifying that the proposed budget was realistic in terms of fulfilling management expectations for the contract.

 

  • Contract lifecycle management (CLM), using digital transaction management (DTM) platforms, such as the Revitas Contract Administration Reporting System (CARS) and Model N Flex contract system.

 

  • Tracked the status of all contracts through various commercial and proprietary contract management systems (CMS).   

 

  • Developed and implemented sourcing strategies that improved the quality of contract execution while simultaneously reducing costs and timelines.

 

  •  Resolved contract issues and claims expeditiously, or escalated them to the appropriate senior management personnel.

 

  • Negotiation, drafting and execution of master agreements (MAs) and master services agreements (MSAs) on a timely basis.

 

  • Managed all aspects of the clinical development contracting process, in accordance with enterprise corporate policies.

 

  • Worked collaboratively with internal stakeholders and outside vendors to ensure optimal partnerships with commitments to high levels of performance, quality and value.

 

  • Established and maintained collaborative relationships with cross-functional business units, such as accounting, compliance, finance, government relations, logistics, manufacturing, procurement, quality assurance/quality control (QA/QC), R&D, sourcing, supply chain.  

 

  • Representation for non-par providers (a/k/a non-participating providers or out-of-network providers), physicians and other healthcare providers that have not agreed to enter into an agreement with any particular insurance payer.​ 

 

  • Experience with business associate agreements (BAAs), master services agreements (MSAs) and a variety of healthcare-related transactional contracts.

 

  • Negotiation and drafting, review of redlines, authoring contract templates, preparation and dissemination for internal subject matter expert (SME) approval. 

 

  • Familiarity with commercial contracts management software platforms, as well as proprietary custom contracts management portals.

 

  • Provided contracts management to diverse business units, such as commercial contracts, coverage gap, diabetes and cardiovascular (DCV), general medicine (including both branded and generic products, in anticoagulants, antihypersensitives and antibacterials), genzyme (including immunology, multiple sclerosis, rare blood disorders, rare diseases and oncology ), medical claims and Medicare Part D.

 

  • Analyzed rebate payments based on contract language and formulary placement. 

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  • Thorough understanding of assigned products, contract strategies and product markets.

 

  • Managed all aspects of contracts management, such as adjudicating claims accurately and fairly, analyzing contract exceptions, analyzing terms and conditions to structure contracts appropriately and updating contracts with amendments.

 

  • Ensured contract compliance for utilization-based agreements.

 

  • Verified that all participants in the contracting process complied with contract requirements.

 

  • Interacted with customers and account managers to resolve any data discrepancies.

 

  • Responsible for verifying the product formulary placement in the approved matrix, and the applying the appropriate standard from the corporate utilization management policy, to ensure the correct placement in the contract tier and thus, the appropriate rebate payment.

 

  • Particular concentration on both contracts management and compliance-related activities. 

 

  • Experience with contracts for the entire lifecycle of contracts for procurement, purchasing, sourcing and supply chain. 

 

  • Experience with contracts in the biotech, life sciences, medical devices and pharmaceuticals.

 

  • Experience with contracts for group purchasing organizations and hospital customer base.

 

  • Experience developing contract templates and playbooks.

 

  • Thorough understanding of related compliance and pricing issues.

 

  • Management of audits, corporate policies and recurring compliance activities.

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  • Performed financial reconciliations related to contract expenditures prior to study termination and eventual contract closure. 

 

  • Managed all aspects of negotiating change orders and sourcing for contracts, to ensure cost-effectiveness.

 

    Last updated 210509_1427

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