Nicole Tay
Medical Affairs Capabilities and Operations
- Role
- Project Manager, Medical Affairs Operations at Endo
- Location
- Jersey City, NJ, US
- LinkedIn followers
- 500 followers
About Nicole Tay
Clinical and Medical Affairs professional with 6+ years of experience across academia, CROs, and global pharmaceutical companies including IQVIA, Eli Lilly, Janssen, and Keenova. Demonstrated success in leading complex, cross-functional initiatives from planning through execution across a broad range of therapeutic areas: Orthopedics, Urology, Men’s Health, Respiratory (RSV), Oncology (Advanced Solid Tumors), Immunology (Juvenile Idiopathic Arthritis, Rheumatoid Arthritis, Chronic Sinusitis), and Neurology (Hypertension, Ischemic Stroke). Strategic thinker, facilitator, and collaborative partner with a strong foundation in biomedical science and pharmacology and a commitment to scientific rigor. Passionate about integrating technology into healthcare, with hands-on experience in digital innovation and system modernization. A clear communicator and team builder who thrives in dynamic environments and drives meaningful change through stakeholder engagement and operational excellence.
Experience
Project Manager, Medical Affairs Operations
May 2023 — Present · Malvern, PA, US
Partnering with IT colleagues to develop version 2 of a patient education and screening app, including involvement in scoping, vendor selection, testing, timeline management and rollout. Coordinating with vendors to successfully execute advisory boards. Managing Fee-For-Service arrangements, business justification, and proof of performance. Overseeing and monitoring Medical Affairs agreements (confidentiality, master service, consulting, collaborative research, IIR, SOWs), purchase orders, compliance tracking, and Sunshine Act reporting. Collaborating with legal, medical and compliance in the non-promotional materials review process. Managing 100+ deliverables and assets - extensive range of physical and digital content. Managing the investigator-initiated research (IIR) program, serving as the primary liaison for internal departments and external stakeholders. Reviewing research proposals, responding to inquiries, coordinating preparation of materials for IIR Review Committee meetings, and overseeing approval workflows. Maintaining comprehensive study trackers, ensuring accurate documentation of communications, decisions, and deliverables. Driving timely payments and drug supply. Leading quarterly IIR update meetings with stakeholders across multiple departments. Supporting the independent medical education (IME), fellowships, and publication grants program. Technical expert in the IIR and grant management system. Spearheaded modernization of system processes, customizing workflows and functionalities to improve user experience, operational efficiency, and data integrity. Supporting implementation of R&D annual plan, ensuring alignment with strategic objectives. Supporting non-promotional, education booths at scientific conferences. Daily collaborative engagements with internal and external stakeholders including legal, compliance, medical, clinical development, medical information, clinical consultants, KOLs and vendors.
Education
University of Melbourne
Master of Biomedical Science, Microbiology and Immunology
2016 — 2017
University of Melbourne
Bachelor of Science - BS, Pharmacology
2012 — 2015
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