Karishma Amin

About Karishma Amin

Strategic and driven leader with 10+ years of experience delivering high-quality clinical and regulatory documents across all phases of development, with deep expertise in rare diseases. Proven track record of building high performing teams, driving best practices, and leading complex global submissions. Skilled in cross functional leadership, document strategy, and implementation of systems and processes that enhance quality, efficiency, and compliance.

Experience

1. Senior Director Medical Writing

   Ultragenyx

   Mar 2025 — Present

   Medical Writing Functional Leadership• Directly manage and mentor an in-house team of medical writers; responsible for overseeing deliverables, capability development, and performance management • Contribute to building the medical writing department by hiring senior and junior writers, developing scalable processes, and establishing best practices aligned with an expanding portfolio• Oversee onboarding and performance of contract writers across multiple programs• Manage resource planning including forecasting, capacity planning, budgeting, and prioritization across programs • Drive/oversee continuous process improvements, including development of standardized processes, document templates and a writing style guide to maximize efficiency, compliance and quality• Test and implement generative AI tools for clinical/regulatory documents, including CSRs and narratives• Partner with leadership to establish department goals in alignment with corporate and portfolio strategyClinical/Regulatory Document Strategy and Execution• Provide subject matter expertise on multiple program teams, including content strategy and preparation of high‑quality clinical and regulatory documents (eCTD modules for INDs and BLAs, CSRs, information requests/RFIs, briefing books, IBs, Phase 1-4 protocols, amendments etc.) across development stages and in support of global regulatory submissions• Drive cross-functional collaboration to harmonize stakeholder perspectives, achieve aligned messaging, and ensure submission readiness and regulatory/ICH compliance• Develop and manage complex submission timelines on highly dynamic programs

Education

• Georgetown University

  Master of Science (M.S.), Biotechnology

• Institute of Chemical Technology

  Bachelor of Pharmacy (B.Pharm.), Pharmaceutical Sciences

• Georgetown University

  Doctor of Philosophy (Ph.D.), Biochemistry and Molecular Biology

Skills

• Medical Writing
• Arisg
• Biochemistry
• Drug Discovery
• Molecular Biology
• Adverse Event Reporting
• Rna Isolation
• Anova
• Mirna
• Immunofluorescence
• Mammalian Cell Culture
• Cancer Research
• Pcr
• Graphpad Prism
• Western Blotting
• Publication Planning
• Protein Assays
• Scientific Writing
• Medical Affairs
• Medical Communications
• Drug Development
• Post Market Surveillance
• Prostate Cancer
• Real-Time Pcr
• Immunoprecipitation
• Clinical Trials