Elise Eller

About Elise Eller

Elise Eller, PhDPrincipal Medical Writer and ConsultantSummaryPrincipal regulatory medical writer with 9+ years of experience in clinical and regulatory documents in a variety of therapeutic areas. Proven track record in leading cross-functional teams, sharing best practices, and managing projects and timelines. Key strengths include collaboration with teams, problem-solving, effective communication, analytical and organizational skills, and identifying and consistently applying messaging throughout a document or submission. My goal is to present scientific information with clarity and accuracy to its intended audience, ultimately delivering therapeutics to the people who need them.Core Competencies- Guidelines and standards: Good Clinical Practice, Good Laboratory Practice, Good Manufacturing Practice, Good Pharmacovigilance Practices, Good Publication Practice, ICH, FDA 21 CFR- Health authorities: FDA (United States), EMA (European Union), MHRA (United Kingdom), PMDA (Japan), NMPA (China)- Document types: protocols and protocol amendments; Investigator’s Brochures; clinical study reports; patient safety narratives, Investigational New Drug modules; marketing application (eg, NDA, BLA, MAA) Modules 2.7.2, 2.7.3, 2.7.4, and 2.5; briefing documents; response to health authority questions/requests for information; extrapolation strategy documents; Investigational Medicinal Product Dossiers; annual reports; DSURs; pediatric investigation plans; risk management plans; manuscripts; abstracts; poster presentations; slide decks- Therapeutic areas: most common: oncology, immunology, gastroenterology, dermatology, hematology, genetic diseases/disorders, rare diseases/disorders, pulmonary/respiratory diseases, cardiology/vascular disease; additional therapeutic areas: addiction, endocrinology and metabolic diseases, epidemiology, hepatology, infections and infectious diseases, nephrology, neurology, ophthalmology, pediatrics, psychiatry/psychology- Software and tools: Microsoft Office Suite, Microsoft Teams, SharePoint, Microsoft Project, templates (eg, TransCelerate, StartingPoint), AMA Manual of Style, PleaseReview, Veeva Vault and other regulatory information management systems, Adobe Acrobat, EndNote

Experience

1. Principal Medical Writer and Consultant

   Whitsell Innovations, Inc

   Jan 2026 — Present

Education

• Brown University

  A.B., Human Biology

  1987 — 1991

• Penn State University

  M.A., Anthropological Genetics

  1993 — 1997

• University of Utah

  Ph.D., Anthropological Genetics

  1997 — 2000

Skills

• Genetics
• Scientific Writing
• Technical Writing
• Cell Biology
• Research
• Organization Skills
• Biotechnology
• Lifesciences
• Scientific Research
• Science
• Grant Writing
• Manuscript
• Science Journalism
• Biochemistry
• Infectious Diseases
• Life Sciences
• Cell Culture
• Molecular Biology
• Medical Writing
• Publications
• Data Analysis