Provide project management expertise to cross functional project teams, including oversight and facilitation of team interactions related to project operations, clinical trials, alliance management, and process improvements. Develop timelines and drive to completion. Manage internal and external medical writing resourcing.

Develop and maintain global integrated cross-functional plansEnsure functional plans are aligned with project strategiesImplement decisions from review boardsFacilitate resource planningManage communication of plans across functions and regions

Project manager in Global Regulatory and Safety organization. Developing project plans as part of regulatory submission strategies for US, EU and emerging markets. Project manage pharmacovigiliance activities. Facilitating and team building to ensure successful project completion.

Project manager in Global Regulatory and Safety organization. Developing project plans as part of regulatory submission strategies for US, EU and emerging markets. Project manage pharmacovigiliance activities. Facilitating and team building to ensure successful project completion.

When my spouse was offered a position in Belgium, I had the opportunity and the good fortune to be able to sell my business and consulting practice and manage our move and experience in Europe.I managed the move, transitioned us through International Drivers Licenses, work permits and our new financial life. Did you know that Belgians don't use checkbooks? Payments are handled electronically directly through internet applications.I took language lessons in Dutch/Flemish.I made our travel plans to most of the major and many of the minor cities of Europe. Favorite airline is Wizz Air, just because of the name.I worked as a contractor for Berlitz. I developed list of key cultural differences and provided cultural training sessions for Europeans considering moves to the US and Americans considering moves to Europe.

Owner/Operator of a Curves fitness facility for women. Small business owner responsible for growth through sales of new memberships and member retention. Facility awarded Shining Star status by Curves International.Created a positive and energetic environment to promote the Curves Experience.Lead staff to achieve goals for new member sales and current member retention. Trained new members and developed and conducted nutrition workshops. We consistently exceeded corporate standards and were award Shining Star status by Curves International in recognition of meeting and exceeding Curves standards.Accounts receivable and accounts payable, payroll, and operational reports as required by the business, Curves International and the state of NJ using QuickBooks and internal member tracking systems.

Independent Project Management consultant to pharmaceutical companies, including Johnson & Johnson and ConvaTec. Experienced team leader with strong communication and facilitation skills. Core competencies include Planning and Organization, Creative Solutions, and expertise in Compliance.By creating usable timelines and closely managing resources and issues for my clients, products were launched on time to meet established financial and competitive goalsProject manager on more than ten large new product releases that met commercialization commitments. Achieved success by clearly defining responsibilities and developing timelines that highlighted risks, issues, resolutions and resources for global, cross-functional teams. Project sizes ranged from teams of eight to teams of twenty-five with timelines of six months to three years. Continual communication across global, cross-functional teams and with executive management was key to my success.Created cultures that promoted compliance with regulations which were critical to successfully meeting milestone commitments.Led User Requirements Definition initiative and User Acceptance Testing efforts for web-based applications including Documentum GxPharma customization and integration to a Project Management tracking website. Wrote Requirements, SOPs, and Validation Reports.Led User Acceptance Testing efforts for new HR application. Created test scripts, facilitated user testing effort and logged and tracked failures through resolution and re-testing.

Small, start-up organization within Johnson & Johnson, Independence Technology, tasked with marketing the iBOT Mobility System. Overall project management for enterprise wide, customer management databases, including Siebel implementation for customer service, field sales automation, product technical support, as well as web site development. Managed $5MM capital budget for requirements and design effort.Drove business process definition for customer service, manufacturing, complaint handling, sales and reimbursement with business partners, both internal and external.Launched interim web site and call center at product reveal, including capture of customer information and response to inquiries.

Small, start-up organization within Johnson & Johnson, Direct Access Diagnostics, tasked with marketing Confide® Home HIV Testing Service.Led the successful development and operation of proprietary, integrated, computer/telephony Production Systems supporting a database/call center for the Confide® Home HIV Testing Service.IT Liaison in FDA pre-approval process. Efforts led to FDA approval and introduction of "First-to-Market" Home HIV product and service.Managed team of 20 consultants from four companies, working on System Development, Computer Validation and Documentation efforts.Budget responsibility for over $3MM in capital expenditures.Computer System Validation effort completed successfully to support product launch. Recipient of J&J Achievement Award.

Various positions in TelecommunicationsProject management services to all domestic J&J companies for large installations of Telephone, Voice Mail and Call Center systems. Installed one of the first voice mail systems at Johnson & Johnson. Responsible for the management of Telephone PBXs at four large J&J sites in NJ and the supervision of a staff of four Bell Atlantic technicians.