Nicole Willard Email and Phone Number

Incident Management

Develops and enhances quality processes to promote, facilitate and ensure compliance with all regulatory and company standards by:Reviewing, approving and analyzing both internal and external compliance related issues and reports, corrective and preventive actions (CAPA), deviations and notes to file (NTF)Ensuring all compliance issues are tracked and trended as well as closed in a timely mannerPerforming all functions of both internal and external quality assurance (QA) audits including audit initiation, conducting the audit, issuing an audit report with pertinent observations/findings, and ensuring corrective and preventive actions resulting from the internal audit are appropriately tracked/trended and resolved accordinglyTracking and reporting data errors detected during review processesCommunicating effectively, verbally and in writing, with all internal and external clientsPerforming QA review of source documents, case report forms (CRFs), offsite shipments and other reports for accuracy as neededDesigns, develops, implements, and assists in management of all quality assurance programs Assisting in identifying and implementing process enhancements to Clario’s quality systems and processes through appropriate stakeholdersConducting external (vendor/supplier) quality audits and hosts Sponsor audits as neededDeveloping applicable Clario training guidelines and SOPs with other stakeholders as neededTraining peers on all functions of the internal/external audits and compliance reporting programs as neededPerforms supervisory functions by, Communicating job expectations, Planning, monitoring and appraising job resultsCoaching, counseling and disciplining staffInitiating, coordinating and enforcing systems, policies and proceduresApproving direct reports time sheets, requests for time off and/or overtimePerforming timely performance evaluations of direct reportsCoordinating and conducting new hire interviews; facilitating hiring decision

· Ensure audit readiness for the QA Analysts and support internal/ external audits, including FDA, Therapeutic Goods Association (TGA), and Notified Body Inspections· Collaborate with internal stakeholders to develop and revise QA procedures necessary to ensure FDA, International Organization for Standardization (ISO), TGA, and Canadian compliance· Perform training to QA Analysts on new processes and/or process changes· Initiate Change Controls for process improvement· Complete NCR QA investigations; conduct interviews and submit final reporting with root cause and corrective action· Monitor QA release data and manage projects to assure expedited turnaround times to meet project deadlines· Write and validate test scripts for new quality management systems· Assist with CAPA initiatives as a subject matter expert· Create new policy and procedures for the QA department.· Monitor and report daily release numbers to QA Management· Participate on special projects and perform additional duties as assigned

 Oversee and monitor open Nonconformance Reports (NCRs) to ensure all activities are being completed in a timely manner Complete independent reviews of NCR deviations to assess level of risk  Review investigations from NCRs for Quality Assurance Compliance (QAC) check Ensure corrective actions are appropriate for NCR closure Lead “Daily Triage NCR Meeting” to conduct initial review of newly submitted NCRs Provide training and guidance on initiation of NCRs and MTF’s internal management system for users Update and review standards operating procedures, work instructions, forms and templates Comply weekly and monthly reports – tracking trends for process improvement Assist cross-functionally on CAPA special teams to ensure QAC is met Participate in internal and external audit as necessary Monitor hold and release of donor status for interim containment Work closely with Processing and Quality Engineers to complete risk and disposition of tissue acceptance and/or rejection Interact on-site and remotely with cross-functional internal teams within MTF Biologics sites

 Monitored both live and transactional Amgen supported activities for quality assurance; overseeing that they are in line with Amgen internal SOPs as well as industry standards as they apply to FDA, OIG, PhRMA code Monitored live Amgen supported activities including Advisory Board (scientific and commercial), Exhibit Space (scientific and commercial), Field Ride Alongs, Speaker programs and Independent Medical Education Meetings Monitored transactional Amgen activities including Field Contact Reports and Speaker Evaluations  Attended Bi-Annual National Sales Training meetings for up to date product information Identified opportunities for improvement based on monitoring findings by tracking trends Assisted in SOP management, process improvements and brainstorming meetings Participated in Sales Training for the Oncology Business Unit for product knowledge Partnered with internal customers to maintain partnerships (legal, sales and marketing, medical information, internal training) Worked with Training Department to create efficient and effective compliance training programs for employees and outside consultants Traveled 70-85% of the time; working remotely Developed in conjunction with outside counsel, processes and worksheets for monitoring within the Worldwide Compliance and Business Ethics Department

 Processed and reviewed medical education requests and donation requests in the areas of Cardiology, Inflammation, Nephrology and Hematology/ Oncology Maintained vendor relationship management  Facilitated contract review and execution Managed status reporting within Amgen as well as with Wyeth

 Developed and facilitated the evaluation process of IME Qualified Recipients (Create performance process; benefiting Amgen by understanding of actual performance achieved: Quality, Cost, Time, Communication - responsiveness, reporting and information exchange, management - dependencies, risk and project management, contract management) Established appropriate Medical Education Strategies to support Educational Goal Boards Expanded current process and procedures of the Medical Education Department Actively receive project updates and timelines from Qualified Recipients on current projects to ensure accuracy, quality and timely delivery of all executed contracts Provided ongoing guidance and training internally and externally on Amgen’s policies and procedures as well as industry standards Developed internal partnerships with cross-functional teams (legal, medical communications, business unit liaisons, compliance and regulatory) Received three Bravo Awards for Leadership

 Managed, directed and lead CME programs for Anti-bacterials (Cipro and Avelox), ACS (Integrilin), Allergy (Clarinex and Nasonex) and Respiratory (Asmanex and Foradil) to ensure professional, timely and quality deliverables within all CME guidelines and procedures (OIG, ACCME, PhRMA code, SP Internal, and others) Negotiated, obtained, and closed executed contracts with CME facilitators and providers in conjunction with directing and leading while overseeing projects from inception to completion Established partnership with Merck counterpart to assist in managing CME activities Interfaced and collaborated with management within other departments to ensure continuity and successful end results Developed reporting systems as well as implement and modify current company policies and procedures Remained informed of market news, trends, and competition activity Established and developed CME strategies for Brand teams in collaboration with cross-functional teams Received Shining Performance Awards from various Brand Teams

 Provided medical review of promotional and CME materials through slide presentations, monographs, journal supplements, and many other print materials Participated in forecasting meetings for business development in both existing and new business to determine areas of improvement as well as new business ideas Maintained current on competitor products by reading journals and participating in industry-sponsored events Assisted the accounts team in managing their budgetary needs by obtaining quotes and/or pricing from vendors Created contact reports for both internal and external communications Attended live promotional and CME meetings, both locally and regionally, for quality assurance as well as to facilitate

 Planned and managed Continuing Medical Education programs for CMD’s largest client product, Viagra as well as other product brands (Detrol, Advair, Flovent, Relpax, Lexapro) Produced the overall medical/scientific content and ensure accuracy with the expert faculty  Prepared documentation of medical/scientific programs to update the client on program status and results  Produced all materials used for medical/scientific programs across multiple physician specialties and therapeutic areas Maintained routine communication with program faculty and accrediting institutions Ensured program objectives are met while staying within AMA and FDA guidelines

 Executed new product launch programs (CME and non-CME) in the form of regional advisory board series, faculty development series, newsletters, and association lunch and dinner symposium for major Rx brands Developed and coordinated symposia series, faculty development series, and dinner symposium for new treatment options in current drug therapies for major global pharmaceutical companies Managed a team of project coordinators specific to each program; overseeing all program deliverables Created many successful programs in the therapeutic indications for prostate cancer, breast cancer and multiple myeloma (Zometa), bipolar disorder (Trileptal), parkinson’s disease (Comtan), and infectious diseases (Faropenem)

 Managed client's CME programs, symposia series, and videoconferences Prepared pre-registered physicians for client's CME programs Created therapeutic category specific databases for client profiling/targeting Developed and implemented the Company’s first marketing plan Redesigned and launched new corporate website Increased agency's corporate awareness amongst potential clients via internet, print, and other mass median