Kyle Irwin Email & Phone Number

Doylestown, Pa, Us

Leads the REMS Operations Team in supporting, standardizing, and improving operations of Janssen’s REMS programs. Responsible for the U.S. implementation of Core Additional Risk Minimization Activities (CARMAs).

Tel-Aviv, Il

Responsible for the development, implementation, and operations of various REMS, RiskMAP, and Pregnancy Registry programs. Managed multiple vendors and a program budget portfolio of over $15 Million. Teva program manager and chair of the audit committee for a complex multi-sponsor shared REMS program. Coordinated and conducted vendor audits. Prepared for FDA inspections regarding REMS programs. Coordinated and supported regulatory submissions and reports for REMS programs. Served as the FDA liaison on a shared REMS program. Presented to FDA on behalf of shared REMS programs.Led vendor evaluation and selection process for multiple REMS programs. Developed internal policies, procedures, and tools for the REMS Operations group. Established and maintained SharePoint document repository for REMS Operation group.Supported the software development process for complex REMS programs including developing program requirements, establishing design specifications, and conducting user acceptance testing.Trained internal team members on REMS programs and requirements. Supervised junior team members. Supported products in a variety of therapeutic areas including: Dermatology, Oncology, Pain Management, and Transplant.

Atlanta, Ga, Us

Provided project management and consulting services to life sciences and government clients. Project manager for a Program Management Office (PMO) tasked with coordinating statewide efforts to promote electronic health records and establish health information exchanges. Managed project schedule, maintained program website, developed status reports, tracked program issuses and risks, and supported program events and conferences. Developed and implemented a performance dashboard for a Sales Operations organization in the pharmaceutical industry. Identified key performance metrics and target values. Enabled the client to identify key issues and opportunities for improvements.

Gb

Provided project management, marketing, and commercial operations consulting services to pharmaceutical industry clients. • Supported the design, development, and implementation of a FDA mandated Risk Evaluation and Mitigation Strategies (REMS) program. Led the vendor selection and evaluation process.• Led an assessment of over 100 e-learning websites for a leading life sciences company. Developed future state vision, requirements, and operating standards. Provided consolidation recommendations and implementation plans that will result in significant administration and operating cost savings.• Led a vendor evaluation and selection support project for the development and operation of a FDA approved Risk Management Program (RiskMAP).• Conducted an operational assessment and provided vendor evaluation and selection support for a FDA approved RiskMAP. Developed requirements and service level metrics, conducted industry and vendor research, drafted a Request for Proposal (RFP), provided evaluation criteria and scorecards, and provided a detailed supplier cost analysis.• Managed a pharmaceutical manufacturer’s web portal operations. Created an operations dashboard report, developed new content, defined functional enhancements, and monitored vendor relationships.• Developed requirements, gathered content, and conducted testing for a web portal solution for healthcare professionals.

Armonk, New York, Ny, Us

• Provided financial management solutions to healthcare and government clients• Provided project management support services including schedule, budget, and scope management to a Department of Defense client. Used earned value management techniques to monitor project status.• Led an initiative to develop hardware and software requirements for a portable accounting and disbursing device.

• Developed detailed cost estimates for large scale government programs. Managed the vendor evaluation and selection for a $500 million government program.• Established a project management office to monitor vendor and subcontractor performance supplying the client with time-sensitive cost, schedule, and quality analysis.• Managed a team of five consultants to collect requirements for a unified financial system. Delivered a requirements report that enabled the client to procure a new financial system.• Created detailed business case analyses used to justify the procurement of new financial systems and to secure funding from Congress.• Developed activity-based costing model sto determine operational costs for various clients.

Mba, Finance, Strategy

Bs, Business