JANET MUSCATELLO
ICON plc (f/k/a PRA Health Sciences)
Basking Ridge,New Jersey
1
Certification
33
years of professional experience
Work History
Vendor Contracts Manager
12 Years- Responsible for leading vendor evaluation and selection process including generation of Request for Information (RFI) if new vendors need to be identified;
- Ensure confidentiality agreements are executed as required;
- Responsible for generating the Request for Proposal (RFP), performing analysis of the responses and leading the clinical study team discussion of vendor selection;
- Conduct budget analysis, to include Fair Market Value (FMV) assessment, contract negotiations and execution for vendors supporting a clinical trial;
- Act as the primary contact with vendors for negotiation of the scope of work, study assumptions and budgets including generation of Work Orders;
- Work closely with Lead Vendor Contracts Manager, Vendor Outsourcing Lead, clinical operations and other relevant functional groups for review and escalation of contract and budget issues;
- Member of study team responsible for attending study team meetings and report status of study-specific vendor/consultant contracts;
- Support cross-functional relationships with clinical operations, legal, finance and other functional study management team members;
- Maintain department and study-level trackers which include current status of deliverables;
- Ensure study outsourcing documentation and trackers are kept in an inspection readiness state at all times;
- May be responsible for generation of Master Services Agreements and Consulting Agreements as requested;
- Responsible for the contract negotiation and management for nonclinical studies;
- Create purchase order (PO) request and maintain PO throughout life of contract;
- Perform follow-up activities for accounts payable issues as related to PO or contractual issues;
- Handle projects and initiatives as requested by the Sponsor; and
- Perform other duties as required.
Consultant/DCAM Outsourcing Lead
11 Months- Properly coordinates and manages sourcing process on behalf of Business Units (BUs) and Development Operations;
- Understands study requirements to secure appropriate level and type of resources and services from Contract Research Organizations (CROs);
- Analyzes bids, identifies and brokers study execution options;
- Selects vendors in connection with the outsourcing of clinical-related services to Labs and Consultants;
- Understands clinical trial operations in order to evaluate feasibility of contract, work breakdown structures and outsourcing needs;
- Gathers in-depth study specifications in collaboration with study teams to enable the compilation of study budgets and work orders;
- Ensures that the company enters into mutually beneficial contractual agreements by negotiating in an agreed legal and budgetary framework;
- Communicates impact of significant contractual changes and associated budgets to BUs;
- Proposes program level or study specific solutions to study teams;
- Knowledge of project budgeting and understanding of project resource needs;
- Ability to translate study requirements into effective contracts;
- Provides budget estimates and modeling options of Alliance Partners or CROs costs;
- Oversees the development of Per Subject Costs (PSC) and associated site investigator grants (US and Rest of World (ROW));
- Liaises frequently with customers and stakeholders to ensure they have realistic expectations of the contracting process, external providers and the contracting environment;
- Provides outsourcing expertise to project teams by identifying and evaluating all outsourcing and resourcing options available in order to facilitate decision making of optimal high value strategy at a global and local level;
- Implements global tools to best support and improve outsourcing management and supplier practice;
- Responsible for obtaining 'real time' external knowledge, expertise, feasibility data (supplier surveillance) and assessment of external commercial marketplace;
- Directly negotiates proposed changes to standard contract language within guidelines provided by the Legal Division; raises significant requested changes to standard contract language to the Legal Division and significant budget exceptions to the appropriate management for consideration;
- Accountable to minimize client's business risk, and maximize research dollars in each contract;
- Prepares or directs the preparation of documents in connection with outsourcing of services such as Request for Proposals, Work Orders, Vendor agreements, Change Orders;
- Coordinates and manages all contracting support for projects sponsored by BUs;
- Collaborates with the Global Business Operations organization and Legal in order to develop improvements to document templates and standard processes and tools;
- Designs payment schedules in order to ensure that payments are made to vendors, according to milestones, for properly performed work;
- Demonstrates advanced understanding of legal concepts and principles as they relate to: Confidentiality, Service, Investigator and Consulting agreements;
- Proactively identifies operational process issues and collaborates with Group Lead and Business Operations staff to develop process solutions;
- Proactively manages customer relations and possible issues; and
- Collects and maintains information for performance metrics and management (e.g. Balanced Score Cards).
Consultant/Clinical Outsourcing Specialist
1 Year- Direct interaction with a wide range of suppliers (Contract Research Organizations (CROs), Cooperative Groups, Clinical Labs, Core Labs, ECG and Imaging Service Providers;
- Assist in the preparation and review of process instructions as well as RFP and contract templates to ensure the proper utilization of tools and templates by project teams (e.g. Scope Documents, RFPs, Transfer of Obligation, monthly reports, service provider evaluations, post-project evaluations/lessons learned, contingency plans, etc.) to improve team effectiveness and efficiency when outsourcing trials;
- Initiate negotiations and execute legal and/or financial agreements in the clinical trials environment;
- Process gate keeper for outsourcing processes providing operational expertise, support, guidance and training to teams on all aspects of outsourced work across Global Development and Medical Affairs (GDMA);
- Provide strategic leadership for outsourced studies, ensuring alignment of teams to the related strategies;
- Drive outsourcing activities by interfacing with operational teams, support groups and service providers for successful selection, contracting and execution of outsourced studies while ensuring compliance with regulatory standards, ethical practices, outsourcing and procurement policies and procedures;
- Liaise with various functional groups to assure project success, including Finance, Finance Resource Managers, Global Procurement, Global Regulatory Science, Discovery Medicine and Clinical Pharmacology (DMCP), Global Recruitment and Analytics (GR&A), and External Data Operations (EDO);
- Act as the first point of contact for the project team regarding outsourcing specific issues, including but not limited to standards and processes, documentation, budget management, contract and change order management, milestone tracking as appropriate for invoicing and issue escalation;
- Ensure active and on-going communication of operational issues between vendor, Global Development Operations (GDO), and support groups;
- Identify critical project/study tasks/issues, consult appropriate functional Subject Matter Experts as needed, and recommend appropriate remediation activities;
- Effectively work in a team and in a matrix environment; navigating and networking with individuals across departments to accomplish tasks;
- Work internationally and with multi-cultural teams;
- Manage key internal and external stakeholders effectively by frequently soliciting input and gathering and incorporating feedback into processes as appropriate; and
- Proactively identify opportunities to provide outsourcing guidance, mentoring and training to the project team;
- Sustain high levels of performance in a constantly changing environment.
Consultant/Outsourcing Manager (Clinical Contracting)
11 Months- Directed the utilization of CROs, Central Labs and Specialty Providers to assure the delivery of quality, timely and cost-effective external resources to support the Novartis Development pipeline;
- Led the selection of the optimum External Service Provider (ESP) (CRO, Central/ Reference Lab, and Specialty Provider) at both the tactical and strategic level based on fit for purpose, or value-added services, cost avoidance and savings opportunities;
- Trained Clinical Teams in outsourcing procedures and assist Clinical Teams in defining the scope of work, and in some cases define the scope of work for both original contract and contract amendments;
- Negotiated contract terms, scope of work, pricing and payment schedules, ensuring that the agreements with the ESPs are commercially advantageous to Novartis, while minimizing regulatory, legal, and financial risks through close collaboration with functional partner such as legal, Finance, QA, and functional lines;
- Produced final contracts/amendments and secure all necessary company approvals including SOX compliance to facilitate execution of said agreements;
- Managed ongoing ESP collaborations (business conflicts, issue resolution, project status, adherence to budget);
- Managed the interface between CCE, internal key stakeholders and where appropriate ESPs to enhance the success of outsourced trials;
- Supported the MSA(s) language and rates negotiations for Strategic and non-Preferred ESPs;
- Contributed to vendor audit requests and facilitate corrective action plans following a CQA audit of non-preferred ESP;
- Ensured ESPs are delivering in line with expectations;
- Led and managed initiatives related to departmental objectives and participate in initiatives related to Global Development objectives; and
- Assisted in coaching and mentoring new associates.
Consultant/Contracts Analyst (Global Pharma R&D Sourcing)
1 Year 1 Month- Supported business development by developing, analyzing, coordinating and negotiating clinical services with suppliers (CRO, IVRS, Central Labs, Imaging, ECG, and HCP), for Johnson & Johnson global program teams from RFP through contract closure;
- Developed, prepared and negotiated contracts for projects on-going at Johnson & Johnson by soliciting input and review from key functional areas;
- Interacted with Legal Department and all levels of management, as necessary, to determine the appropriate terms and conditions to be included in the contracts;
- Attended key operational team meetings and collaborated with team leaders on work orders for existing agreements;
- Facilitated negotiations and discussions to ensure timely execution; and
- Contract Management: developed and maintained files and tracking tools.
Consultant/Clinical Contracts Specialist/Paralegal (General Legal Department)
5 Months- Prepared, reviewed and modified standard agreements, including clinical trial agreements, confidentiality agreements, healthcare professional consulting agreements, informed consent documents, services agreements, software licensing and maintenance agreements and letters of intent; and
- Collaborated with business divisions/project managers to ensure the necessary contractual requirements were established and met.
Consultant/Contracts Specialist/Paralegal (Strategic Sourcing and Vendor Management)
5 Months- Structured, prepared, reviewed and negotiated proposed contracts, form agreements and other legal instruments, including master agreements, licenses, service agreements, maintenance agreements, supplier agreements, statements of work, confidentiality agreements, and other commercial agreements;
- Collaborated with business divisions, IT, supplier management and finance to ensure the necessary contractual requirements were established and met;
- Advised clients and legal management of potential risks and opportunities and assisted internal counsel on related legal matters;
- Provided advice and communicated company policies to clients with respect to contractual transactions;
- Assisted clients in articulating and obtaining approvals for commercial transactions;
- Assisted attorneys in negotiating complex nonstandard agreements;
- Contract Management: supported and lead the continuous improvement of standard forms of agreement and contract administration processes; and
- Ensured maintenance of contractual documents, databases, files and correspondence.
Senior Paralegal (Software Licensing for Compliance, Anti-Money Laundering and Fraud Prevention)
1 Year- Assisted General Counsel with general corporate and contract administration;
- Communicated and coordinated with in-house attorney, company managers and related departments to gather information in the preparation of contracts and other legal documents;
- Drafted and negotiated confidentiality agreements;
- Contract Management: Prepared and maintained various databases regarding licensing terms, source code escrow and maintenance and support services;
- Prepared reports, correspondence and memoranda; and
- Corporate Housekeeping: Maintained corporate record books and drafted resolutions for company and affiliates.
Consultant/Licensing Coordinator for Wyndham Hotel Group (Franchise Administration)
4 Months- Prepared and executed license/franchise agreements, three party agreements and amendments for all Wyndham hotel brands; and
- Coordinated with Manager of Contracts Administration, Franchise Sales Directors and Regional Vice Presidents, owners, operators, financial institutions and attorneys to successfully negotiate all legal related aspects of the agreements and bring those agreements to execution.
Technology Paralegal (Contract Management)
2 Years 10 Months- Drafted and negotiated intellectual property-related contracts, such as confidentiality agreements, software evaluation and license agreements;
- Communicated and coordinated with in-house attorneys, company managers and related departments, clients and/or outside counsel/agencies on select legal issues; and
- Legal Database Management: primary controller for Procuri contracts database, including understanding of the functionality of the system; full access to modify extensively.
Procurement Paralegal (Contract Management)
2 Years 5 Months- Reviewed and analyzed terms and conditions for government and commercial contracts;
- Negotiated revisions to standard contract forms;
- Consulted with procurement team regarding risk assessment and insurance requirements for various subcontracts;
- Assisted in drafting provisions of contracts, confidentiality agreements, client communications and other documents;
- Legal Database Management/ Legal Research: Maintained various databases, including legal library, client bankruptcy lists, license renewals and insurance renewals for prime contracts company-wide;
- Conducted legal research for various legal issues and drafted memorandums with case law analysis;
- Litigation Support: Reviewed and analyzed contractors’ and subcontractors’ claims;
- Prepared documents responsive to subpoenas and document requests; and
- Corporate Housekeeping: Maintained corporate record books, drafted shareholders agreements and resolutions.
Paralegal/Executive Assistant (Legal Assistant to Vice President and General Counsel)
3 Months- Coordinated travel itinerary;
- Prepared expense vouchers;
- Conducted audit for travel expenses for two (2) years prior;
- Obtained passports and visas; and
- Prepared forms and applications for visas and passports for various countries.
Paralegal (Labor Law and Litigation Specialist)
9 Months- Provided assistance in trial preparation and general litigation support;
- Prepared trial binders, exhibits and supporting documentation;
- Prepared deposition synopses;
- Reviewed and analyzed documents regarding labor and employment issues;
- Conducted case file management and indexing of pleadings; and
- Assisted attorneys in drafting of motions and subpoenas.
Paralegal (General Litigation Support)
1 Year 10 Months- Prepared pleading boards, deposition summaries and conducted document reviews;
- Patent and Trademark Prosecution: Assisted attorneys in all aspects of patent and trademark administrative processes;
- Docket administrator for patents and trademarks;
- Prepared PCT filings;
- Drafted daily correspondence to foreign associates regarding patent maintenance fees and trademark renewals and registrations; and
- Conducted trademark searches and obtained various corporate documents involving mergers and acquisitions to be legalized and returned to foreign patent and trademark agents.
Paralegal (Intellectual Property Law and Litigation Support)
1 Year 7 Months- Assisted in document production and conducted legal research on issues involving patent infringement and antitrust violations;
- Assisted attorneys in all aspects of patent prosecution process;
- Conducted competitive analysis research for patent portfolio evaluation;
- Provided database management of AT&T patent license agreements; and
- Prepared drafts for non-disclosure agreements.
Paralegal (Toxic Tort Litigation Support)
6 Months- Assisted attorneys in all aspects of discovery process and trial preparation, including, but not limited to, document production, case file management, preparation of exhibits and analysis of documents to support client's position.
Legal Assistant (Litigation Support)
1 Year 6 Months- Assisted attorneys in preparation of trial notebooks and case file management;
- Drafted pleadings and pertinent legal documents;
- Daily contact with clients and courts; and
- Assisted law librarian, updated pocket parts and shepardized cases.
Education
Paralegal Diploma - Institute of Paralegal Studies, ABA Approved
- Dean’s List, Major GPA: 3.9
- Concentration: Business and Finance
Bachelor of Arts Degree - Political Science
- Dean’s List, Major GPA: 3.75
- Honors: Magna Cum Laude
- Awards: JS Gang Scholarship in Political Science
Skills
Supported documentation and data analysis tasks using Microsoft Office applications.
Assisted teams in collaborating through Microsoft SharePoint for project management.
Facilitated vendor management operations with Aravo software.
Processed data using Oracle systems to improve operational efficiency.
Certification
Licensed Notary Public in New Jersey
Timeline
Vendor Contracts Manager
ICON plc (f/k/a PRA Health Sciences)
07.2014 - CurrentRead More
Consultant/DCAM Outsourcing Lead
Pfizer, Inc.
08.2013 - 07.2014Read More
Consultant/Clinical Outsourcing Specialist
Bristol-Myers Squibb
08.2012 - 08.2013Read More
Consultant/Outsourcing Manager (Clinical Contracting)
Novartis Pharmaceuticals Corporation
09.2011 - 08.2012Read More
Consultant/Contracts Analyst (Global Pharma R&D Sourcing)
Johnson & Johnson Pharmaceutical Research and Development L.L.C.
06.2010 - 07.2011Read More
Consultant/Clinical Contracts Specialist/Paralegal (General Legal Department)
Novo Nordisk, Inc.
04.2009 - 09.2009Read More
Consultant/Contracts Specialist/Paralegal (Strategic Sourcing and Vendor Management)
Horizon Blue Cross Blue Shield of New Jersey
06.2008 - 11.2008Read More
Senior Paralegal (Software Licensing for Compliance, Anti-Money Laundering and Fraud Prevention)
Actimize Inc.
04.2007 - 04.2008Read More
Consultant/Licensing Coordinator for Wyndham Hotel Group (Franchise Administration)
Advantage Human Resourcing
10.2006 - 02.2007Read More
Technology Paralegal (Contract Management)
AIG Technologies, Inc.
11.2003 - 09.2006Read More
Procurement Paralegal (Contract Management)
Tetra Tech EC, Inc. (formerly Foster Wheeler Environmental Corporation)
04.2001 - 09.2003Read More
Paralegal/Executive Assistant (Legal Assistant to Vice President and General Counsel)
Global Crossing
01.2001 - 04.2001Read More
Paralegal (Labor Law and Litigation Specialist)
Lum, Danzis, Drasco, Positan & Kleinberg, LLC
01.2000 - 10.2000Read More
Paralegal (General Litigation Support)
Law Pros
02.1998 - 12.1999Read More
Paralegal (Intellectual Property Law and Litigation Support)
AT&T Corp.
07.1996 - 02.1998Read More
Paralegal (Toxic Tort Litigation Support)
Anderson, Kill, Olick & Oshinsky, P.C.
01.1996 - 07.1996Read More
Legal Assistant (Litigation Support)
Hayden, Perle and Silber, Counselors at Law
06.1993 - 12.1994Read More
Montclair State University
Bachelor of Arts Degree from Political Science
Read More
New York University
Paralegal Diploma from Institute of Paralegal Studies, ABA Approved
Read More