Principal Bios



Aubri Charboneau, PhD, PharmD/MSCR
Managing Member
Principal Scientific Writer

Aubri brings to SAGE SCIENTIFIC WRITING expert medical writing and education services. With over 17 years of research and scientific communications experience, Aubri has experience writing a wide array of clinical and nonclinical regulatory documents for the biopharmaceutical industry. She has served as lead medical writer for several marketed and investigational antiviral products for the treatment of liver disease secondary to viral infection. Aubri also has broad scientific writing experience within both the CRO and biopharmaceutical settings in the following therapeutic areas: HIV (including combination products), neuroscience, cardiovascular, respiratory, metabolic disease, dermatology, oncology, ophthalmology, and gastrointestinal. Prior to entering the pharmaceutical industry as a medical writer, Aubri was engaged in cancer biology research, preparing research proposals for study funding, writing manuscripts, giving professional presentations (posters and seminars), and teaching. She holds a PhD and a PharmD/MS Clinical Research, giving her extensive academic experience in new drug development, pharmacology, experimental design and biostatistics, data management, regulatory affairs, managing and monitoring of clinical studies, and therapeutics.

Aubri.Charboneau@SageScientificWriting.com


Melody Enscore, MS, MA, RAC 
Managing Member
Principal Scientific Writer


Melody brings to SAGE SCIENTIFIC WRITING 25 years of experience managing medical/technical writing, regulatory submissions, and quality assurance staff and services for the pharmaceutical industry and the commercial laboratory industry. She has extensive medical and technical writing experience, as well as expertise and experience in regulatory affairs and quality assurance/compliance, across multiple therapeutic areas. These areas include the following: oncology, infectious disease/antivirals, endocrinology, cardiovascular, dermatology, ophthalmology, gene therapy, women’s health, respiratory, and urology. She has been the lead regulatory writer for numerous product approval applications and supplements/variations, and has written the entire range of individual clinical documents required to progress biopharmaceutical products to market and beyond. Melody has also developed processes for the reporting of clinical trial results in the US and EU, using centralized databanks and study summaries. She has designed and presented training sessions on more than 25 topics related to drug development and scientific writing to various audiences, including clinical investigators, CRO professionals, and pharmaceutical companies. She was most recently global head of medical writing for a major biotech company. Melody also spent 11 years in the CRO industry, primarily as global head of various functions within the regulatory realm (medical writing, regulatory submissions, and clinical quality assurance).

Melody.Enscore@SageScientificWriting.com


Caren Carver, MTS
Member
Principal Scientific Editor and Quality Services Manager

Caren brings to SAGE SCIENTIFIC WRITING expert medical editing and quality review services. She has 20 years of experience editing and writing technical and medical documents, including 17 years of editing experience in the biopharmaceutical and CRO industries. She has lengthy experience managing quality control and editorial review processes for regulatory submission programs (ie, ensuring accuracy and consistency across various related documents in a submission). She also has experience as an author’s editor, with manuscripts published in leading medical journals. She has experience in writing and editing pharmaceutical documents in compliance with the following styles: American Medical Association (AMA), International Conference on Harmonisation (ICH), US Food and Drug Administration (FDA), Vancouver, and Chicago. Her specific drug-development writing and editing experience includes the following therapeutic areas: oncology, antivirals (including HIV and HCV/HBV), anti-infectives, respiratory, neurology, ophthalmology, urology, and dermatology. In addition, Caren has significant expertise in performing and managing quality review of regulatory documents. Caren has completed the medical writing certificate program through the American Medical Writers Association (AMWA).

Caren.Carver@SageScientificWriting.com