Lifecycle Management Global Clinical

April Van Vorst-Meek

908-***-**** linkedin.com/in/aprilvanvorstmeek *******@*******.***

EXPERIENCE

Beigene 8/122- present

Sr. Manager, strategic clinical outsourcing BeiGene, USA, Inc. (Emeryville)

Responsible for the coordination and management of clinical outsourcing needs in support of current and planned global clinical trials, including vendor identification and selection, Request for Proposal (RFP) and negotiating contracts, managing outsourcing budgets, vendor performance metrics and governance, and supporting category strategy.

Responsible for ensuring quality oversight of suppliers and maximizing the value obtained from partnerships with external providers at study, program, or supplier level.

Manages the identification and selection process of clinical vendors.

Contract lifecycle management of clinical contracts and change orders, including active negotiation of scope of work, payment terms and budgets.

Partners with suppliers and internal stakeholders to identify, manage, escalate and resolve issues related to supplier performance.

Measure supplier performance utilizing Scorecard/Metric activities; and communicating feedback to the supplier, encourage adaptation on best practices across supplier types and development of continuous process improvements/ maintenance.

Facilitates and executes supplier governance meeting and operation reviews.

Develops effective partnerships with suppliers and internal stakeholders

Identifies, develops and implements outsourcing processes and procedures.

Leads and contributes to complex functional or company initiatives and special projects as identified by executive management or business need.

Provide analysis and reporting to Clinical Operation Study teams to support the budget review and approval process.

Collaborated with the Clinical Business Operations team to develop and implement a category strategy for patient travel reimbursement services.

Helped implement and coach clinical teams to embrace using category strategies to support clinical trials.

Bristol Meyers Squibb 7/20- present8/22

Sr. Category Manager Princeton, New Jersey

Global Procurement Research &Development – Real World Data

Successfully developed a working model within RWD to streamline the process to effectively communicate with stakeholders regarding high level projects and turn-around time.

oInteract with senior level management to discuss current and upcoming projects for the year. Oversee and work closely with the sourcing excellence group and legal to develop, strategize and execute contracts in relation to the projects driven by the Business. Review payment schedules for contracts. Identify changes in agreements such as wording with sourcing excellence and the legal department to coordinate any changes requested in areas of the contract that are critical to compliance. Monitor changes to agreement and oversee the project to completion.

Collaborate with suppliers such as: medical institutions, hospitals, CROs and registries globally and locally to collect de-identified patient level data for many different projects (related to biological and pharmaceutical research for cancer, diabetes and antipsychotic medications to name a few). The research that is conducted may also lead to the generation of posters, manuscripts, white papers, etc. Often times, FMV is conducted to ensure that those medical physicians are within the current market range.

Contribute toward cost savings by working closely with the Business and senior level executives to align with yearly budgets and realization of actual costs and the need for certain projects to move the business forward.

Set-up weekly standing meetings with stakeholders, business units and legal to discuss strategy and budget specifications.

Collaborate with stakeholders and senior management in conducting risk assessments of company operations and develop risk mitigation strategies to ensure compliance with US laws and export control.

Establish strong stakeholder relationships with professional advocacy organizations to gain alignment on strategies aimed at increasing brand awareness globally for marketed products

Merck Sharp & Dohme 3/18- 6/20

Sr. Sourcing Manager, Research & Development Procurement Kenilworth, New Jersey

Center for Observational & Real World Evidence (CORE)

Perform and manage all activities associated with the development and execution of contracts with academic institutions, research institutions, clinical investigators, vendors, consultants, and others including the preparation of MSAs, SAs, amendments, change orders, RFPs etc.

Prepare and negotiate all CDAs, contracts, contract amendments and or/review budgets and assist in preparation of scopes of work in alignment with existing MSAs. Create payment schedules for contracts according to Merck guidelines.

Identify changes in agreements such as wording to the legal department and coordinate any changes requested in areas of the contract that are critical to compliance. Work with fair market value team to ensure that financial analyses of contracts budget requests and met and submit for approval.

Monitor and track all changes to agreement scope up to and including the final executed version.

Update SAP contract status tracking system for all agreements, contracts and budget information.

Interact with other departments domestically and abroad (global medical affairs, stakeholders, global medical affairs, legal, compliance and risk management.

Work with FDA on REMS assignments to ensure that the benefits of a Merck drug outweigh the risks associated with the drug.

Bristol Meyers Squibb 10/17- 03/18

Global Procurement Buyer Princeton, New Jersey

Strategic Sourcing Excellence

Confer with senior management in conducting risk assessments of company operations and develop risk mitigation strategies to ensure compliance with US laws and export control

Established strong stakeholder relationships with professional advocacy organizations to gain alignment on strategies aimed at increasing brand awareness globally for marketed products.

Meet with cross-functional teams to gather information and lead group toward costs savings through efficient document management. Sign-off on contract approval sheets after having negotiated the agreement. Contribute toward cost savings by working on contracts to collaborate negotiation strategies with attorneys (in-house and outside counsel) compliance and various sourcing clients to meet projected yearly savings goals

Verizon 6/11-5/17

Sr. Sourcing Manager-Category Expert Marketing Basking Ridge, New Jersey

Sourcing dept. (marketing & advertising) 9/2015-5/2017

Legal dept. 6/2011-9/2015

Successfully achieved a savings of 9M for my targeted budget within 1 year by initiating strategy discussions with key stakeholders to narrow current supplier pool to effectively utilize preferred suppliers for cost savings.

oCollaborate and gather marketing info to finalize LOAs, SOWs and purchase orders within the marketing and research space. Work with outsourcing offshore team to finalize agreements. Worked with management to drive diversity spend to align with corporate diversity team.

Negotiated and finalized domestic and international agreements such as technology, outsourcing call center, supply chain, licensing, vendor, data purchase/sale, services, research and development, employment, and confidentiality agreements Supported the legal department in the following areas: IT, compliance, network, training and marketing. Develop, review and negotiate SLAs, GSAs, GPAs, SOWs, Confidentiality Agreements, Letters of Intent, Trial/Test Agreements, Amendments, Change Requests, SOWs and RFPs; negotiate limitations of liability; compliance with laws to minimize future liability issues.

Understanding and negotiation of SlA’s to provide company with limited risk and enforce CPNI. Work on trial software license agreements in a controlled environment as well as a server monitored environment.

Collaborated with senior management and scientists in conducting risk assessments of company operations and develop risk mitigation strategies to ensure compliance with US laws and export control

Collaborate with suppliers such as: medical institutions, hospitals, CROs and registries globally and locally to collect de-identified patient level data to ascertain whether this data can be used to further a drug in another therapeutic arena.

Established strong stakeholder relationships with professional advocacy organizations to gain alignment on strategies aimed at increasing brand awareness globally for marketed products

Meet with cross-functional teams to gather information and lead group toward costs savings through efficient document management. Sign-off on contract approval sheets after having negotiated the agreement. Contribute toward cost savings by working on contracts to collaborate negotiation strategies with attorneys (in-house and outside counsel) compliance and various sourcing clients to meet projected yearly savings goals.

Merck & CO, INC. 3/09-1/11

Global Procurement Sr. Sourcing Manager (dates 12/09-1/11) Whitehouse Station, New Jersey

Hand-picked from procurement to join a divestiture procurement team of 6. Successfully divested many Schering sites globally. Developed and strategized a plan to divest sites with using prior career experience.

oDivest sites globally. Meet with outside counsel, on site employees and upper levelupper-level management to ensure smooth transition.

Meet with senior level management and sub-departments (HR, Quality, IT, etc.) to develop, implement, and communicate appropriate network strategies; review all contracts (transition, toll, supply and confidentiality agreements)

CRO’s that included the Gardasil vaccine that I helped to offer to first year students in colleges; work with business to negotiate RFPs, RFI’s to choose correct vendor to minimize overall spend

Confer with in-house and outside counsel to draft agreements; develop and oversee due diligence process for each project; oversee and manage the execution of the re-sourcing process for assigned categories including management of external and internal communications; prioritize categories based on demand for overall cost savings; managesavings; manage metrics for transition of supply

Develop templates and fall-back language for future use; negotiate terms and language with various buyers. Travel to various countries to meet and negotiate with potential buyers

Meet with all cross-functional counterparts in corresponding sites to determine site demand, spend and company forecasts to predict measures of the divesture outline. Utilize SAP to input information, store contracts, retrieve templates and generate POs. Seek and work with overseas counsel to assist in divestures.

Paralegal II (dates 3/09-12/09)

Provide paralegal support, advice, guidance, counseling and constructive feedback in a positive and effective way as needed to Global Procurement and other areas as requested by attorneys. Look to attorneys for support and direction when necessary in order to deliver the highest level of support. Specific GP/GBS areas of interaction include: IT, Marketing, Commercial Services Aviation, Real Estate, Global Site Services and Shared Business Services.

Draft routine documents including but not limited to Confidentiality Agreements, amendments, letters, memos and one-off agreements. Prioritized workload in order to satisfy client needs and meet deadlines. Attend various meetings to observe negotiation approaches/tactics/techniques between legal, stakeholders, outside counsel and external personnel to learn and continuously develop negotiation skills needed to work with a diverse client group.

Initiated and coordinated meetings between clients to communicate Legal's position on certain issues and address potential risks involved in accepting supplier terms.

Town Sports International (NYSC) 2/08-1/09

Real Estate Paralegal New York, New York

Reviewing, analyzing, organizing and administering leases, subleases and licenses; Administer creation of lease abstracts

Preparing notices to landlords and other parties; Address and respond to notices and inquiries from landlords, lenders, and other parties; Conduct due diligence investigations

Draft lease amendments, extensions, renewals, commencement date agreements and related ancillary documents; Prepare and negotiate estoppel certificates and confirm certifications set forth therein; Review and negotiate subordination, non-disturbance and attornment agreements; and interact with, and provide oversight of outside counsel.

BARNES AND NOBLE COLLEGE BOOKSELLERS, INC. 2/07-2/08

Supervisor, Vendor & Training Manager Basking Ridge, New Jersey

Negotiate and review IT-related vendor contracts to insureensure compliance by vendors within parameters of Service Level Agreements; Supervise the procurement analyst; review all vendor invoices and insure timeliness of payment

Coordinate with infrastructure services to determine necessary parameters for IT operations equipment and service vendors; coordinate with the Business Applications group to determine required hardware, software and services vendors; work with Finance Department to verify the financial requirements of IT contracts that are in line with expectations; work with Enterprise Risk manager to insure that security and Disaster recovery requirements are contractually supported; act as a liaison between the key vendors and suppliers; and maintain calendar for expiration and negotiation for IT related contracts

Coordinate with PMO to identify projects that will require end user or IT training; insureensure that training materials are created, available and accessible to trainers and trainees. Work with other IT policy-makers to create policy-awareness campaigns through the BNCB organization, including the field. Research and implement the latest equipment and pricing that is beneficial to the organization.

ANN TAYLOR RETAIL, INC. 4/06-7/06

Lease Administration Paralegal New York, New York

Abstraction of leases, lease amendments and modifications into REM. Review leases as they relate to the deal sheet for accuracy and interpretation of lease language

Review and preparation of storage agreements. Handle store issues and resolve. Responsible for verification of all abstracts, lease amendments by Lease Administrator in REM

Processing of Estoppels and SNDA's. Management of all documentation through the scanning and filing process, including the application of OCR, saving to the central electronic repository and filing of documents into appropriate lease file

Creation and management of all lease notices and legal documentation for lease administration and real estate group including maintenance of all deal sheets. Management of all co-tenancy provisions as they relate to the signing, possession operating and operation of the store/center.

THE CHILDREN'S PLACE 8/04-4/06

Real Estate Paralegal Secaucus, New Jersey

Participated and led a discussion for new process improvements to enhance and shorten the length of time to negotiate and enter the criteria of all standardized leases.

oAdministrator for real estate manager program "Accruent-REM". Abstraction of leases. Lease review and negotiations

Heavy contact with various store managers, landlords and law firms to discuss current outstanding issues. Enter tenant allowance information, send out default letters

Review, edit and finalize Estoppel Certificates, SNDA's; storage agreements, roof leak letters and commencement date letters; revise and draft memos, letters and proofreading. Write reports and abstracts using business objects. Track construction allowances, write letters of default. Prepare weekly lease status reports; input data on SiteSeer Real Estate Manager, Chief Legal Officer and Accruent; design organizational charts using powerpoint; prepare excel spread sheets for lease tracking

THACHER PROFFITT & WOOD 7/97-7/04

Legal Assistant/Supervisor New York, New York

Successfully rebuilt my department after 9/11 by reaching out to clients to retrieve all documents that were lost. Scanned all documents, worked in a remote setting for 2 years to reinstate the firm since all documents and files were lost.

oSupervise word processors and temps assigned to the department to ensure team work throughout the department. Contribute input for yearly performance reviews. Distribute current projects and assist others with word processing applications while providing technical software support

Coordinate work projects for 37 Attorneys within the Banking Department to ensure that deadlines are met for client satisfaction. Other duties include: heavy contact with various banking departments. Type and distribute prospectuses, agreements, certificates and quarterly reports; all phases of legal preparation including revisions and drafting of memos, letters, proofreading, answering phones, billing and time entries. Prepare legal documents of a highly confidential nature, maintain attorneys' calendars, including follow-up on pending matters, set up meetings and arranges travel reservations; design Powerpoint presentations and excel spreadsheets. Set up conference calls, order lunch and dinner and provide car service to attorneys and clients as needed.

EDUCATION

New York Institute of Technology

MBA, HUMAN RESOURCES MANAGEMENT New York, New York

GPA 3.6 2006

Kean University

Bachelor of Arts in Psychology, Major: Psychology Minor: Pre-law Union, New Jersey

1994

Seton Hall University

Paralegal Certificate South Orange, New Jersey

Software: Word 2007; Word 2010, Powerpoint, Excel, SAP

PROFESSIONAL AND ACTIVITIES

Pro-bono work – Street Law & Domestic Violence cases

Angel Paws – volunteer

Lifetime Running Group; certified Yoga Instructor

LANGUAGE SKILLS

Fluent in English with three years of study in Spanish

REFERENCES

Available upon request

Contact this candidate