Manager Management

ANNETTE K. ELLIS

CAREER SUMMARY

Over ** years within the Pharmaceutical industry with combined strengths in quality and compliance sustainability across various development organizations, scientific research, strategic sourcing (procurement), vendor management and industry costs standards.

Demonstrated success in developing, formatting and taking into live production a global system for tracking supplier evaluations, performance metrics and issue resolution.

Successful negotiator, high-performing Contract Outsourcing Professional with broad expertise in developing and executing multiple complex supplier and service related agreements.

PROFESSIONAL EXPERIENCE

AbbVie Pharmaceutical INC., North Chicago, IL 12/14 – Present

Assistant Director, Global Research and Development, Contracts and Outsourcing

Responsible for the quality of all work products through management of 12 direct reports. This includes RFI/RFP, service agreements, master agreements, and all other contract types as applicable for my direct reports.

Responsible and accountable for both the guidance and leadership of direct reports, and the performance of, the development and maintenance of effective collaborations with internal and external stakeholders.

Lead initiatives and ensure appropriate team member assignment to initiatives to support growth and development of the department and the staff.

Accountable for all outsourcing deliverables, related contracts and other compliance documents in support of assigned portfolio and staff. Act as SME for strategic sourcing initiatives as requested. Contribute at an expert level and provide leadership and guidance to develop direct reports to attain SME status via mentoring and coaching.

Responsible for prioritizing and assigning workload across the portfolio to ensure adequate resources to support business needs. Responsible for escalating resource concerns strategically and prospectively to senior outsourcing management leadership to meet peak demand.

Communicate, liaise and train internal customers on the contracting process and managing the life cycle of a contract.

Novartis Pharmaceutical Inc., East Hanover, NJ 01/11 – December 2014

Senior Outsourcing Manager, NIBR Clinical Sourcing, Responsible for negotiating and finalizing clinical trial agreements at Phase one units, Academic organizations and private Principal Investigators. Responsible for identifying vendors and working closely with the team to identify outsourcing requirements. Supporting finance and resource management by ensuring a total trial grant is in place for any external activity. Working on special assignments to develop process and implement. Responsible for on-site CRO evaluation and Phase 1 conduct site approval in alliance with QA. Complete documentation and Audit process, procedures and final approval documentation.

Baxter Healthcare, Medication Delivery, New Providence, NJ 09/10 – January 2011

Sr. Contract Administrator, Responsible for reviewing contract request, drafting, finalizing and executing multiple agreement types, procurement of supplies.

Pfizer Global Research and Development, New York, NY, USA 1990 – May 2010

Associate Director, Contracts and Outsourcing 2007-2010

Developed processes, Visio flow charts and implemented training for new company acquisitions, transitions, in-licensing and co-promote situations.

Played an instrumental role in setting specifications for ARIBA Contract Systems; functioned as the Pfizer US trainer for the Ariba Contract system (Super User).

Outsourcing lead for therapeutic area committees for Inflammation, CNS, Oncology, and Infectious Disease.

Continued sourcing and contracting process, RFI, RFP proposal and cost evaluation, cost reduction and savings, identify potential global vendors, render patient recruitment services and business qualification of companies; Including all CRO’s, translations, Consulting, Licensing and Clinical Site Agreements supporting all the necessary clinical trial requirements.

Vendor audit and audit response point of contact participate in audit, review and follow any minor and major findings through completion.

Created and managed a portfolio of categories and suppliers to engage appropriate stakeholders in support of global vaccine trials.

Manager, Contracts and Outsourcing 2001-2007

Manage the development and implementation of Requests for Proposals, Contracts, Master Service Agreements, Work Orders and Amendments for CRO’s, specialty vendors and clinical laboratories.

Identified over 400 global laboratories to be evaluated in a global Preferred Provider Request for Proposal project, including researching companies (locations, capabilities and affiliates). Prepared questionnaires, co-led face-to-face meetings for criteria matching, conducted on-site lab GLP qualifications and audits, price negotiation and final selection. Results included the following:

oHarmonized bidding process with negotiated fixed costs.

oStandardized process and global templates.

oConsistency of work utilizing a smaller pool of common vendors.

oNegotiated annual clinical savings over $5 Million for global Master Service Agreements, including $500 thousand savings for clinical sample storage.

oLaunched cross-functional Lab Forum Team to monitor ongoing performance.

Served as the single point of contact for instituting specialty testing of Biomarkers and Pharmacogenomic sampling at new laboratories and for reviewing method validations.

Functioned as a subject matter expert to perform protocol design review and clinical sample optimization for the Budgets and Contracting zone of the Optimizing Project Delivery initiative, providing feedback and recommendations to clinical teams and therapeutic area managers in executing cost effective protocols. Manage study budgets, including direct review and invoice discrepancy resolution.

Established vendor relationships through development of laboratory evaluation forms and a process for internal use, followed by quarterly laboratory reviews with customers.

Participate in cross-functional team meetings to establish criteria for outsourcing and cost drivers.

Participated as the SOX representative for Resource Performance Management

Supervisor, Clinical Research Technicians 1998-2001

Direct supervisor to ten colleagues and contract research technician staff at the Phase I Unit/Pfizer Research Clinic.

Responsible for project planning and implementation of all laboratory and technical study activities at the Phase I Clinic, including the management of multiple aspects of data acquisition, involving regulatory compliance.

Procured new equipment set up maintenance programs and logs for equipment, set-up electronic notices for calibration time-points and trained on the operation of equipment and laboratory instruments.

Developed new testing procedures to enhance laboratory efficiency and productivity.

Trained all laboratory technicians and clinical staff in safety and collection procedures (Phlebotomy, Biohazard and ECG).

Drafted, reviewed and updated all operational Standard Operating Procedures pertaining to the Phase I Unit operations in the laboratory. These were adopted and utilized, which standardized processes that were rate limiting.

Provided technical assistance in the management, transfer and safe handling of Phase I Unit study samples and specimens.

Senior Associate Scientist 1990- 1998

• Developed testing characteristics of lead compounds to determine efficacy (used methods including HPLC, Dissolution, IR, and GC).

• Prepared documentation and presented information and results to pharmaceutical sector via videoconference.

Specified, procured, set-up and arranged validation for all equipment and necessary supplies for new contract laboratory in Puerto Rico.

• Designed procedures for method development, validation and training for NDA product at contract labs.

Quality Control Analyst, Leeco Diagnostic, Southfield, MI 1989 – 1990

• Monitored quality control of products and kits using radioimmunoassay (RIA) and Enzymeimmunoassays (EIA).

• Conducted statistical quality control checks.

Research Technician, University of Michigan, Internal Medicine, Ann Arbor, MI 1987 – 1989

• Accomplished clinical trials under physician supervision.

• Reviewed protocols to determine adequacies and resources required for clinical trials.

• Set-up patient screening followed by kinetic modeling and statistical coordination of study results.

Assay of samples (Plasma, Serum and Urine), collected via HPLC, Beta and Gamma RIA.

Research Technician, Wayne State University, Endocrinology, Detroit, MI 1986 – 1987

Harvested endocrine glands from laboratory animals for research experiments.

Measured intracellular concentration of cardiovascular hormones stimulated by drug absorption in female rats.

Related Work Experience

• Oakland General Hospital, Madison Heights, MI (Laboratory Technician 1986-88)

• Highland Park Community College, Highland Park, MI (Immunohematology Instructor 1984)

EDUCATION and CERTIFICATION

• Bachelors of Science Degree in Biology and Chemistry, Northern Michigan University

• Certified Medical Laboratory Assistant, EKG Technician, Phlebotomist and Histologist, Regional Occupational Program

Series I & II Managerial negotiating and project management (Parkdale) 1994

Strategic Sourcing Methodology, McKinsey & Company three day course 2002

The Successful Negotiator, two day course 2003

Six Sigma Yellow Belt 2007

FDA Audit and Inspection readiness training 2002 – 2003

Paralegal Certification, completion June 2016

PROFESSIONAL ASSOCIATIONS

• American Chemical Society, 1992

Toastmaster, 1999 - Present, President 2000, 2009 First place winner Table Topics Area & Division

American Clinical Pharmaceutical Units, 1998

COMPUTER SKILLS

Microsoft Word

Microsoft Outlook

Microsoft Power Point

Microsoft Excel

Microsoft Project

Microsoft Visio

ARIBA

Computron

PICAS

Grant Manager

OSCAR – contracting repository system

PIMS – Real time data collection system

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