Regulatory medical writing professional with over 10 years of in-house pharmaceutical medical writing, scientific writing, and leadership accomplishments. SUMMARYLed pharmaceutical medical writing department of ~30 members with robust in-house capabilities, including medical writers, quality control specialists, process specialists, and project managers Led creation and improvement of global in-house regulatory document development infrastructure and templates Leveraged internal and vendor resources to deliver quality medical writing deliverables in a high-volume, fast-paced environment Played active role in regulatory approvals of a number of biologic drugs (DUPIXENT® [dupilumab] for atopic dermatitis and LIBTAYO® [cemiplimab] for cutaneous squamous cell carcinoma]). Led medical writing activities for marketing application of oncology drug Expertise across a wide range of medical documents and therapeutic areas