About Us  Medical Communications & Project Management Team
  Safety & Regulatory Affairs Team
 
Medical Communications & Project Management Team
 

Zeinab Schwen, MS
President, Strategic Regulatory Consulting

Zeinab Schwen has over 28 years’ experience in clinical research, medical writing, and regulatory submissions in the pharmaceutical industry.  Ms. Schwen also brings extensive business management experience to SRC -- from marketing, finance, and project management.   For the past 19 years, Ms. Schwen has founded and managed ProMed Communications, a successful medical communications company.  ProMed is an important part of the SRC team which focuses on medical and regulatory writing for the pharmaceutical and device industry.  ProMed has contracted with numerous major pharmaceutical and medical device companies such as Procter & Gamble Company, Marion Merrell Dow Pharmaceuticals, Eli Lilly and Company, Ethicon Endosurgery, Inc., ICOS, Meridian Diagnostics, Nova Nordisk, and many more. 

Ms. Schwen also brings to SRC her clinical trial management experience that she gained during her 10 years of employment at Marion Merrell Dow and later in her own company.

 
Roy M. Kulick, MD, MBA
Senior Clinical Consultant

Dr. Kulick is an MBA-trained physician who brings to SRC over 20 years of experience in both healthcare delivery and medical-related businesses. While at Procter & Gamble and Ethicon Endo-Surgery, he led the development and execution of strategic clinical research programs and innovative clinical trial designs for a broad spectrum of pharmaceutical and medical device technologies. With his dual research/business training and experience, Dr. Kulick is uniquely positioned to understand and align R&D and marketing objectives.

Dr. Kulick has a track record for leveraging the expertise of key global thought leaders to meet both research and business needs and successfully working with the FDA as well as other governmental and non-governmental organizations in both the U.S. and abroad. His medical writing and editing experience includes numerous peer-reviewed journal articles, clinical trial protocols and reports, promotional material and regulatory documents.
Dr. Kulick received his medical degree from the University of Pennsylvania and is board certified in Pediatrics and Pediatric Emergency Medicine. In addition, he has a M.S. in Clinical Research Design and Statistical Analysis from the University of Michigan and an M.B.A. from Xavier University in Cincinnati.
 

 

Gayle Entrup, MEd
Managing Editor


Gayle Entrup h
as 25 years’ editorial experience in medical writing, journal submissions, and educational materials.  For the past 10 years she has also managed quality assurance audits of clinical study reports, labeling requirements, and patient narratives.  Experience includes analysis of data from case report forms and various databases.

 

Martha Dillow, MA
Senior Medical Writer

Martha Dillow has over 30 years’ experience as a medical and regulatory writer.  She has been the lead writer on numerous clinical study reports for many of our clients.  Her expertise includes patient narratives, clinical study reports, manuscripts, and she is also an instructor of written and oral communications.

 

Additional Team Members

Wendy Wippel, MS
Erin Omera, MS

 
 
Strategic Regulatory Consulting
3130  Highland Ave., Suite 3060

Cincinnati, OH. 45219-2374,USA
513-475-4085 Phone

513-489-4730 Fax
 
SRC@srcteam.com
www.srcteam.com