|Maria Lopez, Senior Team Lead
is an experienced writer, editor, and leader of teams developing clinical and nonclinical documents and managing development of full submissions.
|Pat Ollinger, PhD, Senior Team Lead, CMC & Clinical
has developed cross-functional expertise encompassing writing, editing, and managing teams in the development of high-level regulatory documents.
|Suzi Keating, PhD, Senior Team Lead, Clinical
has written and edited a variety of clinical regulatory documents, including sections of submissions, and has therapeutic area experience with cardiovascular, diabetes, hemophilia, oncology, and skin and soft tissue infections.
|Lora Chavis Killian, Transparency and Disclosure
is responsible for the development and oversight of Synchrogenix’s entire suite of transparency services which includes anonymization, clinical trial disclosure, and lay language summary development.
|Nirpal Virdee, Director, Client Services, Technology
is accountable for business development, client management and consulting for technology enabled services.
|Dawn Guyer, Senior Document Quality Associate, Quality Manager
is an experienced company trainer, technical editor, project leader, and writer. She also performs quality control (QC) review (requiring checks for appropriate content, appearance, and compliance to style specifications) on various submission documents as well as mentors colleagues to develop the skills and experiences needed to be successful at Synchrogenix.
|Jenny Go, MD, Regulatory Writer/Associate Team Lead
is a registered physician with clinical and school physician experience at the Mapúa Institute of Technology in Manila, Philippines. Dr. Go has written clinical summaries of safety, narratives, literature summaries, safety data, clinical study reports, and clinical trial results disclosure.
Nigel Batchelor 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.
Ann Benesh has 14 years of pharmaceutical and biotechnology writing experience and 6 years of clinical research experience as a clinical research associate.
Michael Bourque has over 15 years of global medical writing and clinical research experience across numerous therapeutic areas and specialties including antifungals, vaccines, gastroenterology, hepatology, and pediatric medicine.
Valerie Breda has more than 15 years of experience as a clinical research and regulatory associate in the pharmaceutical and medical device industries. Ms. Breda has written a variety of clinical and nonclinical regulatory documents across therapeutic areas, most notably oncology, hemophilia, and immunology.
David Falcone has experience as a regulatory writer, editor, and project manager with expertise in post-approval documentation, drug safety, and pharmacovigilance.
Pat Woods has more than 20 years of experience developing strategies, writing, editing, and leading clinical writing teams for the pharmaceutical and medical device industries.
Kim Norris has over two decades of experience in clinical, regulatory documents from investigational new drug applications (INDs) through electronic submission, with a particular emphasis on neurology and both hematologic and solid tumor oncology and special expertise in protocol development.