Medical Writer Device

COLLEEN P. DUFFY

623-***-**** Flagstaff, AZ ********@*****.***

SUMMARY

Detail-oriented, skilled medical writer and editor with 25+ years in Pharma, Medical Device, and Academic Medicine. Specializes in translating complex information into clear, concise content that adheres to industry and government standards. Demonstrated ability to manage projects and meet strict deadlines. Experienced in clinical trials, regulatory compliance, and technical documentation.

SKILLS/CORE COMPETENCIES

Technical writing and editing

Medical device documentation

Clinical trial documentation

Abstracts/manuscripts/posters

White papers

Educational materials

Medical textbooks/manuals

Drug safety/pharmacovigilance

Drug evaluations/monographs

Pharmacology/pharmacokinetics

FDA regulatory compliance

Regulatory document preparation

Bilingual communication

Grant proposals

Project management

Copyrights/permissions

Literature research

Style guides: American Medical Association, Chicago, Associated Press

Microsoft Office Suite 365

LANGUAGES

English and Spanish

EMPLOYMENT

Medical Writer (contract). Orakle Digital. London, England/Orlando, FL. 2025

American Society of Transplantation conference: Cutting Edge of Transplantation 2025. Scottsdale, AZ.

Editor and Technical Writer (contract). Software Logistics. Tampa, FL. 2023

Edited descriptive reports, software text, and tracked data to bring a new software program to market.

Career Sabbatical.

Caregiver for parents. 2008-2014

Volunteer for equine-assisted learning programs for children and adults with disabilities. 2013-present

Medical Writer (contract). MGI Pharma, Global Drug Safety/Pharmacovigilance (Oncology). Bloomington, MN. 2006-2007

Wrote patient narratives detailing reports of adverse events in a clinical study to bring a new drug to market.

Medical Editor (contract). EMC Paradigm Publishing, College Division. St. Paul, MN. 2005-2006

Edited the textbook and lab manual, Biotechnology: Science for the New Millenium (by Ellyn Daugherty 2006), and Applied Anatomy and Physiology: A Case Study Report (by Brian Shmaefsky, PhD 2007).

Sr Medical Technical Writer. Medtronic, Cardiac Surgery/Heart Valves/Perfusion. Minneapolis, MN. 2002-2004

Coordinated writing projects to ensure timely completion and compliance with industry standards.

Authored and edited regulated documents for medical devices; instructions for implanting heart valves.

Mentored junior staff in medical writing/best practices.

Medical Writer. Express Scripts, Drug Evaluation/Drug Safety. Bloomington, MN. 1996-2002

Authored/edited drug-evaluation documents for clinicians; statistical data; drug interactions; adverse events.

Authored patient- and consumer-education materials (for print and DrugDigest.org).

Mentored pharmacy students and staff in medical writing, best practices.

Editor. Dain Bosworth, Research. Minneapolis, MN. 1995-1996

Edited reports/documents on healthcare companies to enhance final stock-market publications.

Editor. University of California, Medical Center, Epidemiology. San Diego, CA. 1992-1994

Edited/rewrote original clinical trial results for peer-reviewed journal submissions; wrote federal grant proposals.

Coordinated and tracked peer-reviewed manuscript submissions; verified adherence to journal requirements resulting in increased quality and acceptance rate of published research.

Mentored researchers and students in writing/editing best practices.

ADDITIONAL RELATED EXPERIENCE

Writing Assistance. Plymouth, MN. Edited and rewrote medical documents.

Fairview University Press. Minneapolis, MN. Edited the Manual of Lung Transplant Medical Care 1st edition.

MedNews. Sao Paulo, Brazil. Edited Portuguese to English case reports for the Brazilian Dermatology Society.

Salud Miami. Miami, FL. Translated and edited Spanish medical case reports into English.

University of California, Medical Center (Heart Transplant/Cardiac Surgery; Head and Neck Surgery). San Diego, CA. Organized and managed logistics for an international surgical conference; created teaching materials and presentations; compiled data and authored statistical reports for accreditation by the Joint Commission for the heart transplant program; administration.

University of Minnesota Hospitals/Clinics, Divisions of Colon/Rectal Surgery; Plastic/Reconstructive Surgery; Heart Transplant/Cardiac Surgery; Epidemiology. Minneapolis, MN. Authored and transcribed medical text in Spanish and English; administrative duties; grant proposals.

PUBLICATION

Hamid MR, Daley DM, Chitwood-Dagner KK, Brown RE, Duffy CP. Impact of proactive drug information services in a pharmacy benefit manager (PBM) [abstract] Am Coll Clin Pharm. American College of Clinical Pharmacy. Spring Practice and Research Forum. April 2-5, 2000, Monterey, CA.

EDUCATION

Bachelor of Arts (Phi Beta Kappa): Medical Anthropology and Spanish. University of Minnesota, Twin Cities.

Graduate Studies: Public Health and Social Work. University of Minnesota, Twin Cities.

Foreign Study: Fundación de Ortega y Gasset. Toledo, Spain.

CERTIFICATIONS

Medical Writing: Advanced and Core certificates. American Medical Writers Association.

Editing: Copyediting, content editing, and series editing certificate. University of California, San Diego.

MEMBERSHIPS

American Medical Writers Association

Professional Editors Network

Phi Beta Kappa Society

VOLUNTARY SERVICE

Board member. American Medical Writers Assoc, N. Central Chapter and National Constitution/Bylaws Committee.

Interpreter for Spanish-speaking hospital patients/families. University of Minnesota Hospitals/Clinics and University of California, San Diego, Medical Center.

Horse handler, leader, and riding coach for children/adults with disabilities. Horses Help. Phoenix, AZ. 2013-2020

Horse handler for an equine-assisted learning program. Horses, Heroes, and Hope. Flagstaff, AZ. 2020-present.

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