Sydney Dudley, DVM

Regulatory medical writer with a strong foundation in pharmacology, toxicology, and clinical medicine. Specialized in driving nonclinical content for IND and NDA submissions. Proven ability to develop clear, regulatory‑compliant documents including eCTD Module 2 summaries, nonclinical overviews, and Investigator's Brochure content.

Recognized for translating complex data into concise, submission‑ready narratives and collaborating effectively with subject matter experts in fast‑paced regulatory environments.

Nonclinical Regulatory Medical Writer (Subcontractor) - Medical Writing Solutions – Regulatory Medical Writing Agency - United States

(2024-06)

Authored complex nonclinical regulatory documents supporting successful IND and NDA submissions to the U.S. Food and Drug Administration (FDA). Led development of eCTD Module 2 nonclinical documents (Module 2.6 and 2.4) while ensuring compliance with relevant regulatory guidelines. Contributed to the nonclinical sections of the Investigator's Brochure and FDA briefing documents, ensuring scientific accuracy, consistency, and alignment with regulatory expectations.

• Project 1: NDA submission to U.S. FDA for the treatment of hypertension (small molecule)
• Project 2: IND submission to the U.S. FDA for the treatment of autoimmune diseases (small molecule)
• Project 3: BLA submission to the U.S. FDA for the treatment of autoimmune diseases (bifunctional mAb)
• Project 4: IND submission to the U.S. FDA for the treatment of hypoadrenocorticism (small molecule)

Senior Emergency - MEDVET Animal Hospital - Commerce, MI

(2025-06 - 2026-01)

Authored clear, accurate clinical documentation and translated complex medical information into concise, client-ready materials. Authored and delivered daily presentations that communicated clinical data clearly to multidisciplinary teams. Demonstrated strong document ownership, communication, and deliverable management in a fast-paced, high-accountability environment. Led cross-functional teams under time-sensitive conditions to support decision-making and achieve defined clinical objectives.

Senior Emergency Clinician - BluePearl Veterinary Partners - Southfield, MI

(2022-06 - 2025-06)

Prepared high‑quality clinical documentation, including detailed clinical case summaries and client‑facing materials. Developed, reviewed, and delivered training content for hospital teams, translating complex medical concepts into accessible written and verbal communication. Reviewed scientific publications and applied findings to support evidence-based clinical protocols and operational improvements.

Produced high-quality documentation in a fast-paced environment requiring accuracy, prioritization, and independent judgment.

Student Researcher - Michigan State University - East Lansing, MI

(2019-05 - 2019-08)

Conducted detailed literature reviews to identify genetic targets for modulating the host immune response as it related to Marek's disease. Developed and implemented research protocols that supported the successful creation of genetically modified fibroblast cells targeting killer T-cell activation. Maintained thorough records to enable reproducibility. Prepared and presented findings at institutional and national research forums.

Doctor of Veterinary Medicine - Veterinary Medicine - Michigan State University, College of Veterinary Medicine (2022)

Bachelor of Science - Neuroscience - Michigan State University, College of Natural Sciences (2017)