Roxane Smith Email & Phone Number

•Responsible for all areas of project delivery including discovery, definition, scoping, planning, configuration, delivery & initial support while- managing business & technical expectations. •Manage team and client needs that require independent judgment, in order to implement R-Squared Service and Solutions Products which specialize in healthcare, life sciences and biomedical compliance solutions.•Employs independent judgment in guiding highly complex activities involved in the successful implementation of an integrated business solution, ensuring project quality and timely delivery within budget to the customer's satisfaction. •Analyzes business needs to help ensure client objectives are met by combining industry best practices and solution knowledge. •Effectively applies industry methodologies, policies, and procedures while adhering to contractual obligations, minimizing risk and exposure. As a project lead, assists collective project team with all aspects of their roles. •Influences and direct decisions at the senior management level of customer organizations. •Ensures deliverables are acceptable and works closely with the customer to understand and manage project expectations. •Manage direct reports – directly related to project or assigned to other company implementations.•Support others on implementation projects as SME. •Lend expertise to company software development projects, as necessary.

Areas of responsibility: Aggregate Spend/State Disclosure Reporting, Wholesale Distribution Licensure, State and Federal Agency Report - Sample and Trade Product, Data Managment Office of Ethics and Compliance, HCP State Law•Responsible for managing corporate process for complying with all state and federal laws mandating reporting spend related to Health Care Professionals (HCPs) and Health Care Entities (HCE). Partnered with the Legal department, ensuring appropriate interpretation and internal documentation of the laws and regulations. Responsible for training staff in analyzing legal implication of state laws on employees’ interaction with HCPs.•Created systems & processes to manage oversight of distribution licensure for third party distributors shipping on Takeda’s behalf. Represent Takeda’s licensing obligations for co-distribution/co-promotion endeavor•Reported theft, loss, significant loss and falsification violations involving physician samples and warehouse trade product as required by the Prescription Drug Marketing Act (PDMA) and State government agencies.•Identified developed, supported and maintained data and database needs for Office of Ethics and Compliance (OEC) for US and affiliate expansions to support overall Compliance Policies and SOPs when required. Lead and managed all OEC IT related projects.

Deerfield, Il

• Designed and implemented programs that monitor physician sampling activities ensuring Takeda program rules reflect PDMA, and state regulation standards. Created and implemented training programs. Prepared and presented metrics to senior management when required. Coordinate and participated in field sales sample related investigations. Participated in field audits of current or potential third party fulfillment vendors. • Collaborated with I/T to develop solutions or support processes to minimize risk.• Trained new Corporate Security Investigators and Human Resource Managers on sale force systems and processes relating to sampling activities and standards. • Represented Sample Compliance perspective when working with Human Resources, Corporate Security, Marketing, IT, Legal, and in new product endeavors and product launches.

Managed customer master maintenace activities for company's sales force. Identified and resolved system related customer master issues. Member of customer master development team, establishing companies first (and currently used) HCP master.

Bs, Health Education

Bs