EXECUTIVE LEADERSHIP   

  

Ellen Barrosse, CEO

Ms. Barrosse founded Synchrogenix in 1986 as a one-person writing company, then called Writers, Inc. Under Ms. Barrosse's leadership, Synchrogenix has grown into a global multimillion-dollar regulatory writing company that serves pharmaceutical and biotech clients worldwide.

 

 

 

 

 

  

Kelley Kendle, Director of Marketing and Business Development

Ms. Kendle cultivates and ensures the satisfaction of Synchrogenix's clients worldwide. She is a senior member of Synchrogenix's leadership team, guiding the company's strategic growth, business processes, and organizational dynamics.

 

 

 

 

 

 

 

 

Ms. Moroz is a seasoned executive with extensive experience in operations and project management. She leads all aspects of Synchrogenix’s global operations and plays a crucial role in the organization’s strategic planning.

 

 

 

 

 

  

PRINCIPAL WRITERS

 

Michele Boyd (San Diego, CA) has 20 years of experience in both managing and writing in the pharmaceutical industry.

 

Nigel Batchelor (High Wycombe, UK) has 20 years of experience in regulatory writing and project management, and an additional 15 years in microbiology manufacturing quality control and research and development.

 

Mary Jane Lunsford (Austin, TX) has more than 23 years of experience in both managing and writing in the clinical research industry.

 

Steve Sibley (Malvern, PA) has more than 20 years of experience preparing nonclinical and clinical documents and leading project and submission teams.

Pat Woods (Wilmington, DE) has more than 20 years of experience developing strategies, writing, editing, and leading clinical writing teams for the pharmaceutical and medical device industries.

 

 

TEAM LEADS

 

Paul Antle (Matrix Responsibility, Quality Control) has written and edited regulatory documents crossing all phases of the drug development lifecycle.

 

David Falcone (Drug Safety & Pharmacovigilance) has experience as a regulatory writer, editor, and project manager with expertise in post-approval documentation.

 

Kim Green (Clinical Trial Disclosure) has written and edited nonclinical, clinical and drug safety documents and worked with global regulatory bodies.

 

Marilyn Ingram, RN, BSN, (Clinical) has experience as a clinical writer and manager of clinical writing teams in global CRO and biotech environments, as well as 15 years of nursing experience.

 

Maria Lopez (Clinical and Nonclinical) is an experienced writer, editor, and leader of teams developing clinical and nonclinical documents and managing development of full submissions.

 

Pat Ollinger, PhD, (CMC and Clinical) has developed cross-functional expertise encompassing writing and editing and managing teams in the development of high-level regulatory documents.

 

Tatyana Wanderer, PhD, (Clinical) has experience in clinical writing and project management of a variety of ICH-compliant documents, with expertise in documentation related to rare disease indications.