Jun Yan, PharmD

Jun Yan, PharmD, has extensive experience in medical writing and regulatory affairs. Jun is currently serving as the Director of Medical Writing at Provention Bio, starting in March 2023. Prior to this, they founded Jun Yan Medical Writing, LLC in 2012, where they worked as a Regulatory Medical Writer and Consultant. In this role, they provided writing and advisory services to pharmaceutical and biotech companies, specializing in inflammatory/autoimmune diseases, neurology, oncology, and other areas. Jun had a broad range of responsibilities, including writing various clinical documents for regulatory submission and offering expertise in drug development and regulatory guidelines.

Before starting their own company, Jun Yan gained experience as a Medical Writer at CROfessionals, Inc. from October 2011 to November 2012. Jun was responsible for writing and editing regulatory documents such as clinical study reports, protocols, investigator's brochures, and informed consents. Jun also provided regulatory strategy and submission planning advice to biotech and pharma clients.

From June 2010 to October 2011, Jun Yan worked as a Pharmacist and Labeling Reviewer at the FDA. In this role, they reviewed company-proposed prescribing information for compliance with regulations and contributed to labeling reviews for New Drug Applications (NDAs).

Additionally, Jun Yan has had freelance experience as a Medical Writer and Editor. From December 2007 to June 2010, they wrote and edited clinical study reports, manuscripts for publication, and news articles. Jun also served as a Senior Writer for Psychiatric News, the official newspaper of the American Psychiatric Association, where they reported on clinical, epidemiologic, and scientific research, as well as pharmaceutical industry and regulatory news.

Jun Yan's earlier career included roles as a Medical Writer at MedImmune, Inc. from June 2006 to June 2007 and at Centocor Research and Development from January 2005 to May 2006. In these positions, they wrote clinical regulatory documents, participated in new drug development and study design, and contributed to regulatory submission activities as part of clinical research teams.

Before transitioning into medical writing, Jun Yan worked as a Manuscript Editor for the peer-reviewed pharmacy journal American Journal of Health-System Pharmacy from February 2000 to January 2005. Jun also gained experience as an Intern Pharmacist at Kaiser Permanente from June 1996 to May 1999.

Throughout their career, Jun Yan has demonstrated a strong background in pharmaceutical sciences, clinical research, regulatory affairs, and pharmacy practice. Jun has a deep understanding of drug development, regulatory guidelines, clinical operations, biostatistics, and pharmacology.

Jun Yan obtained a Pharm.D. degree in Pharmacy from the University of Southern California, where they studied from 1995 to 1999. In June 1999, they also obtained the Registered Pharmacist (RPh) certification from the California Board of Pharmacy. In addition, Jun Yan holds a certificate in Medical Writing for the Pharmaceutical Industry, although the month and year of obtaining this certification are not provided.