Renee Lozon Email & Phone Number

Spring House, Pennsylvania, United States

Greater New York City Area

Responsible for relationship management of key strategic external Clinical Research Organizations within Janssen Research & Development's Global Clinical Development Operations.

Titusville, Nj Usa

Responsible for developing long term strategic vision of Clinical Supply Chain (CSC) looking out 3 to 5 years. Utilize Voice of the Customer insights from Pharmaceutical Development & Manufacturing Sciences (PDMS), industry data, and close collaboration with CSC leaders to develop the best possible strategy for the organization.Global project management lead for key innovation and improvement projects within CSC and PDMS organization ensuring risk identification and mitigation, resource management, and timeline management for successful delivery of projects.Decision Support Lead assignment for 18 months for Clinical Supply Chain (CSC) Management Team driving long term strategy for the Value Stream including the yearly Goals & Objective cycle. Developed and executed CSC’s Long Term Strategy Workshop in 2015 for 30 senior and mid-level cross-functional leaders. Objectives included obtaining internal stakeholder feedback, defining and shaping the future vision for Clinical Supply Chain, identifying key long-term projects, and developing a sustainability plan. Partnered with Pinta Consulting for facilitation support of the event.People Leader within the CSC Strategy group. Recruit talent, develop goals & objectives, create individual development plans, provide mentoring and coaching, and ensure associates are recognized for their work. Global Process Owner Team Lead for CSC. Deliver successful process improvements, develop long term strategy along with goals and objectives, perform impact and gap analyses, audit and inspection support, and development of new core processes. Personal development opportunity as Research Project Manager for Collaborative Research Agreements with the London and Boston Innovation Centers in the Research Immunology Discovery organization. Managing business relationships, timelines, resources, and budget while focusing on Health Care Compliance and risk to understand earlier stages of our business.

Titusville, Nj Usa

Led cross functional global Clinical Supply Chain Technical Teams responsible for design and demand management of clinical supply manufacturing, packaging, and distribution for multiple compounds. Responsible for defining kit and label design, development of IVRS supply specifications, creation of distribution strategies, development and communication of timelines, risk management, and budget management.Served as CSC lead and Clinical Team representative on CMC Teams for large molecule compounds and small molecule compounds. Strong partnerships built within CMC Team including CMC Regulatory, Analytical Development, Drug Product Development, Quality, Portfolio Management, Project Management Office, API Development, and JSC New Product Launch.Served as CSC lead and CMC Team representative on global, cross functional, multidisciplinary Clinical Teams ensuring clinical trial plans, concepts, and blinding needs are feasible from a CMC perspective and global First Patient In dates achievable. Influence study design and operational aspects in order to create cost efficiency aligning with capabilities. Provide project status information, plan alternate scenarios, manage timelines, develop and manage trial budgets for packaging, outsourcing, comparator, and distribution.Led internal sub-teams within Clinical Supply Chain for High Performing Organization and World-Class Planning & Forecasting for Clinical Demand Forecasting.

Titusville, Nj

Senior Manager for Cardiovascular, Metabolics, and Pain Therapeutic Area within Clinical Supplies Unit responsible for managing and developing 5 direct reports and oversight of 12 compounds. Responsibilities included oversight of a team of CSU Product Coordinators, performance management, training and development, coaching and mentoring of staff. Work with CSU Customers to establish and maintain accurate long-term forecasts for assigned portfolio of products. Developed agreements on scope of work and timelines for CSU deliverables at a compound level. Provided strategic influence for timing and scope of work on Phase I - IV studies. As needed, assumed Product Coordination role for specified compounds/trials. Identified and resolved issues affecting CSU deliverables and customer satisfaction. Led IVRS Strategic Charter within CSU in 2009 to reduce specification approval time and develop standard processes. Received Standards of Leadership Award in January 2010 for contributions leading to the successful filing of NDA for Tapentadol Extended Release tablets (marketed name Nucynta).

Responsible for the global coordination, ordering and follow-up of all clinical supplies for assigned compounds. Worked closely with internal clinical partners and external in-license partners to obtain forecast information regarding clinical supplies for bulk drug manufacturing and packaging. Communicate updates regularly with team members. Prepared supply plans for each trial in Phase I through Phase IV, including all updates due to changes in recruitment, expiry of supplies, comparator issues, and regulatory changes. Determined clinical supply specifications for IVRS requirements per trial as needed and communicate supply chain and distribution data to the IVR vendor.Provided key planning data to statistics team members for generation of trial randomization.Follow FDA, ICH and Annex 13 guidelines for generic label text and clinical supply packaging. Ensure clinical roadmap timelines are met in order to meet launch goals for NDA filing. Provide batch information as needed for NDA filings. Participate in FDA audits as needed.Dedicated Chemical and Pharmaceutical Team member to ensure that regulatory needs, bulk drug, comparator, and analytical requirements are communicated and delivered. Determine the distribution strategy for each trial. Work closely with global distribution providers and assist Sourcing with creating distribution agreements. Responsible for meeting key performance indicators and managing clinical supply program budgets by compound.Received Standards of Leadership in December 2008 for succesful NDA submission of Nucynta Immediate Release tablets.

Responsible for overseeing pharmaceutical manufacturing and supply chain tasks on a daily basis while maintaining GMP and DEA compliance through effectively deploying resources.Responsible for 20 packaging lines for cold chain products, controlled substances, transdermal, and solid dosage products as well as manufacturing processing for tablets and suspension.Department champion for controlled substances. Responsible for interpreting DEA guidelines and requirements, controlling security access, and assisting with internal risk-assessment audits and DEA inspections.Provide guidance and coach packaging associates, processing technicians, and mechanics on the supply chain process, personal development, and MRP system.Department champion for the Environmental ISO-14001/MAARS team, participated in November, 2004 audit.Investigate nonconformances and quality deviations through collaborations with Regulatory Compliance, QA, Engineering, Technical Operations, Validation, and J&J affiliates. Handle grievances, discipline staff when necessary, interview and recruit new associates, maintain personnel records, and conduct training for new associates. Project management of Changeover Reduction Initiative for Controlled Substance bottle packaging lines. Led a cross-functional team in benchmarking activities with Latina, Italy and Schaffhausen, Switzerland for manufacturing best practices in April 2005. Completed Process Excellence Green Belt Training in 2004

Manage fourteen suppliers for printed components in Puerto Rico and the U.S. Implement and maintain Supplier Excellence techniques among all suppliers to ensure Six Sigma level of quality and improved supply chain management with printed suppliers.Negotiate contracts with new and existing suppliers to meet business needs and strategic initiatives. Determine alternate sources of supply when necessary and assist with implementation and sourcing of anti-counterfeit technology for pharmaceutical packaging including security measures for delivery and manufacturing. Conduct executive level quarterly team meetings with four core suppliers to review performance metrics, quality issues, team projects, and future requirements. Identify and implement cost saving opportunities through rebates, new printing techniques, and reverse auction results. Identify any cost avoidance opportunities as they arise. Utilize vendor-managed replenishment for key suppliers reducing days of coverage.Conduct e-auctions for printed components. Gather requirements and evaluate opportunities where e-business can enhance supply chain excellence.Expedite component orders with suppliers during product launches to ensure speed to market. Participate on all launch and product teams at PSGA.Implement SAP MRP system within PSGA as procurement Subject Matter Professional and Site Readiness Leader representing Supplier Management, which includes data cleansing, data migration, system implementation and end-user training for twelve months leading up to implementation. Assist with implementation of reduced testing methods at all printed suppliers while maintaining quality sigma ratings and reducing lead times. Participate in supplier audits and quality assessments to ensure that suppliers meet FDA requirements for Good Manufacturing Practices. Project management of all Source of Supply projects for Printed Components.Received two Standards of Leadership Awards.

Fort Washington, Pa Usa

Project leader for timeline management of printed component production for new product launches, redesigns, and base business copy changes for McNeil and Johnson & Johnson●MERCK franchise brands. Worked closely with marketing to meet design needs.Managed ten vendors in the U.S. and Puerto Rico for cartons, labels, shippers, print mats, pouches, color separations and design work. Assist J&J•MERCK Lancaster facility with development and implementation of Supplier Managed Inventory (SMI) for two printed component suppliers. Develop and implement new pricing system for SMI itemsManaged printed component pricing in SAP system for all McNeil and Johnson & Johnson•MERCK Consumer Pharmaceuticals brands as well as support the implementation of strategic pricing for these componentsSAP Power User for National Purchasing. Trained departmental employees with SAP system and assist with troubleshooting any problems. Performed testing for support packs, upgrades, and new module implementation. Developed new process within the system to facilitate year-end pricing of all components.Managed annual budget for prepress and design work for three franchise brands in excess of $730,000 Member of National Purchasing’s Systems Strategy Team investigating and implementing e-procurement methods for on-line procurement.

Mba, Pharmaceutical Managment

Executive MBA curriculum in Pharmaceutical Management

B.S., Production And Operations Management

Activities and Societies: Phi Mu Sorority