1. Kenneth W. Rundell
Summary
• Business-savvy regulatory professional looking to facilitate business development through project
management, risk mitigation, and analytics.
• Exemplified strong analytical, interpersonal, and presentation skills while managing multiple projects
simultaneously.
• Organization-wide recognition for technical knowledge of controlled documents within Documentum
and B.DoCS electronic document management systems.
• Proven ability to apply current Regulatory Guidance standards to innovative and sustaining
• cross-departmental change proposals to ensure proper handling in today's
• Regulatory Environment.
Skills
• Medical writing (white papers, product
monographs, research papers, grant
proposals)
• Editing
• Publishing
• Medical Affairs
• Regulatory submissions
• Medical information
• Adverse Event reporting
• Data base: FAQs, AEs
• IND, NDA
• Producing slide decks
• Presenting webinars, P&T committee
meetings
• Product training, internal and external
• Respiratory research
• Cardiovascular research
• Radiology
• Phlebotomy
• Biology laboratory equipment
Core Competencies
• Process Improvement, Submission Risk Management, and Project
• Traceability
• Electronic Data Management Systems and Controlled Documentation
• Microsoft Word, Excel, PowerPoint, Visio, and Access
• Strong Ability to work with all levels of the organization
Education
B.S. Kent State University (Biology)
M.S. Elmira College (Biology / Education)
Ph.D. Syracuse University (Physiology). 1991 Dissertation, SUNY Health Science Center
College of Medicine, Department of Physiology. AMP Deaminase in Rat Skeletal Muscle.
Post Graduate Education
Post Doctorate Research Fellow, Department of Physiology, SUNY Health Science Center College of
Medicine, Syracuse, NY. 1991-92
Certified Radiographer, Pennsylvania State Board of Medicine and the Pennsylvania State Board of
Osteopathic Medicine. 2003
Designated Pharmaceutical Representative, California State Board of Pharmacy, Department of
Consumer Affairs. License # 21064. 2010-present
Work History
Pharmaxis INC. USA,
August 2012 to August 2014.
Medical Affairs Consultant.

2. • Prepare/present 3 product slide decks in person or via webinars to medical customers.
• Present at hospital P&T committee meetings for product approval.
• Provide on-site and remote product training.
• Write and distribute product Medical Information Letters.
• Acted as contact for product inquiries and complaints.
Pharmaxis USA,
August 2010 to August 2012.
Director of Medical Affairs.
• See above bullets.
• Write product SOPs, monograph, white papers.
• Interface with KOLs.
• Review Investigator Initiated proposals and act as person of contact.
• Provide medical/scientific support to Marketing, Regulatory and sales personnel.
• Coordinate medical communications/information to healthcare providers.
• Provide product training to sales personnel.
• Act as “first contact” for potential adverse events.
Keith J. O’Neil Center for Healthy Families. Marywood University.
June 2002 to June 2010.
Professor of Health Science, Director of Respiratory Research and the Human Physiology
Laboratory.
• P.I. for several asthma and COPD phase II-IV Clinical Trials.
• P.I. For several grant funded air pollution, cardiovascular, and asthma research studies.
• Supervised Physiology Laboratory Coordinators, interns, volunteers, several graduate student
Master’s and Ph.D. theses and Medical Fellows from UPMC and Geisinger Health System.
• Taught graduate level Physiology and Laboratory Techniques, teaching in the Physician’s Assistant
(P.A.) program and supervising graduate students.
• Presented lectures/symposiums on air pollution toxicology, cardiovascular and asthma research at
many National and International meetings.
• Presented Grand Rounds Lectures at major Universities such as Yale, Hartford Hospital, Geisinger
Medical System, UPMC, John’s Hopkins, University of West Virginia, Laval University, University of
Rochester and several others.
• Member of three task force groups (ATS, AAAAI, Canada EIB Technical Panel) for management and
treatment of exercise-induced asthma.
• Served on the International Olympic Committee Medical Commission for both asthma and air
pollution.
• Acting KOL in respiratory for Merck Inc.
United States Olympic Committee.
June 1992 to June 2002
Senior Physiologist and Laboratory Director at the Lake Placid USOTC.
• Developed the sports science laboratory.
• In charge of all physiology testing, blood work, asthma evaluations and lab management.
• Performed environmental health related research on air pollution and muscle blood flow in
collaboration with the University of Pennsylvania.
• Performed asthma research.
• Member and reviewer for several scientific/medical journals.
• Acting KOL in respiratory for Merck Inc.

3. Editorial Responsibilities
• Medicine and Science in Sports and Exercise, Reviewer, 1994-present.
• The Journal of Strength and Conditioning Research, Reviewer, 1995-present.
• The Journal of the American Medical Association, Reviewer, 1995-present.
• Medicine and Science in Sports and Exercise, Editorial Board, 1997-present.
• The Journal of Strength and Conditioning Research, Editorial Board, 1998-present.
• The British Journal of Sports Medicine, Reviewer, 1999-present.
• The Journal of Asthma. Reviewer. 2000-present.
• World Anti-doping Agency. Grant Reviewer. 2000-present.
• Chest, Reviewer, 2002-present.
• Medicine and Science in Sports and Exercise, Associate Editor, 2002-2004.
• Medicine and Science in Sports and Exercise, Associate Editor-In-Chief, 2004-2007.
• Annals of Allergy, Asthma & Immunology, Reviewer, 2003-present.
• American Journal of Respiratory Medicine, Reviewer, 2003-present.
• European Journal of Applied Physiology, Reviewer, 2004-present.
• European Respiratory Journal, Reviewer, 2004-present.
• Physiology Measurements, Reviewer, 2004-present.
• Respiratory Medicine, Reviewer, 2005-present.
• Scandinavian Journal of Medicine and Science in Sports, Reviewer, 2005-present.
• Society for Free Radical Biology and Medicine (SFRM). Judge for submitted abstracts for 12th Annual
SFRM Meeting. Abstract Reviewer. 2005.
• American Heart Association Mid Atlantic Consortium Study Section. 2006.
• European Respiratory Society. Grant Reviewer. 2008.
Special Task Responsibilities
International Olympic Committee Air Quality Panel member. Charge: To advise Olympic organizers
on daily Beijing air quality concerning athlete health risk from competition in sub-optimal air quality. 2007-
present
International Olympic Committee Asthma Consensus Meeting member. Charge: To define and
publish guidelines and criteria for asthma medication use during international competition. 2008Technical
Expert Panel (TEP) member of The Evidence-based Practice Centre (EPC) for the Agency for
Healthcare Research and Quality for Exercise-Induced Bronchoconstriction and Asthma. 2008
Technical Expert Panel member of the American Thoracic Society Clinical Practice Guideline entitled
Management of Exercise-Induced 2008
Bronchoconstriction. Charge: To develop and publish guidelines for physician management of EIB.
2008
Exercise-Induced Bronchoconstriction Practice Parameter Task Force member of the American
Academy of Allergy Asthma and Immunology.
Charge: To develop and publish a practice parameter for physicians who provide care to patients with
EIB.
2009-present International Olympic Committee Asthma Panel member. Work with anti-doping
agencies as a liaison for the IOC in defining objective criteria (tests) and cut-off values for asthma
medicine use in Olympic competition.
Exercise-Induced Bronchoconstriction ATS Guidelines. Charge: To develop and publish guidelines
for physicians who provide care to patients with EIB. 20010-2012
Publications (Over 100)
PubMed link: http://www.ncbi.nlm.nih.gov/pubmed/?term=rundell+kw