Work Experience

 

  • May 2022 - May 2024

    A two-year rotational program where I supported Immunology and Oncology therapeutic areas as well as Global Policy and Intelligence and Global Labeling as part of the Regulatory Engagement and Development Team. I supported 12 products, had over 200 regulatory submissions, and served in leadership positions with the Scientist Mentoring and Diversity Program and Alliance for Diverse Abilities Employee Resource Groups. I received 13 Inspire awards from colleagues for my continued excellence and participation in programs.

    • Tremfya

    • Stelara

    • JNJ-2113

    • Talvey

    • Carvykti

    • Darzalex

    • Rybrevant & Rybrevant/Lazcluze

    • Imbruvica

    • TAR-200

    • Product lifecycle management

    • Global pediatric clinical study submissions

    • Early target labeling

    • Regulatory strategy documentation

    • Regulatory intelligence: small drug and large molecule regulatory differences & rheumatic labeling indications

    • IND/CTA applications and information requests/queries for the US, EU, and South Korea

    • Safety submissions

    • Clinical protocol development and oncology governance for multiple myeloma

    • Cross-company collaborations

    • sBLA submission

    • Project ORBIS, breakthrough designation, and priority review

    • Aggregate reporting

    • Competitive intelligence on real-world data/evidence (RWD/E), rare diseases, and orphan drug designations

    • Interactive dashboards with PowerBI

    • Policy positions and policy comments on RWD/E to FDA and ICH

    • Pediatrics and RWD/E advisory boards with PhRMA and BIO

    • Communication strategies and commenting participation

    • Company Core Data Sheets and US/EU Prescribing Information for cell and gene therapy products

    • Tool development for greater regional input to labeling documents

    • Local labeling deviations

    • Communications and cross-functional input to labeling documents

    • Meeting and documentation management

    • Career fairs and networking events

    • Mentorship development

    • Website design and development

    • Event planning and management

    • Resource development

    • Speaker and knowledge sharer