Chapter Meeting: May 6, 2006

SPEAKER:

Dr. Susan E. Caldwell

TOPIC:

Regulatory Writing—Skills and Thrills

BIOGRAPHY:

Dr. Susan E. Caldwell earned a PhD in medical microbiology and immunology, has postdoctoral training in infectious diseases, and has 19 years of experience in the biotechnology, biopharma­ceutical, and medical device industries. She has worked in the areas of drug discovery, clinical research, process development, and drug and device manufacturing. More recently, she has headed medical writing departments for 11 years at three biotechnology companies, a clinical research organization, and now at Biotech Ink, LLC. Through Biotech Ink, Susan provides medical, scientific, and technical writing services to the biotech­nology, pharmaceutical, and medical device industries. Writing services are available to clients in collaboration with experienced contract medical writers, many of whom Susan has known and worked with over the years. Writers are matched to projects based on expertise, education, availability, and even personality. Susan also provides writing services, and manages virtual medical writing teams for her clients. The company offers writing support for a wide range of document types. These include regulatory documentation for preclinical, clinical, process development, and manufacturing; medical manuscripts, abstracts, posters, and slide presentations; web site content; SOPs, guidelines, work practices, templates, and style guides; and market reports. Biotech Ink also offers graphics and electronic publishing services for regulatory submissions.