Susan E Caldwell, PhD, is an accomplished Medical Writer Consultant and President of Biotech Ink, LLC, with extensive experience in medical writing, reviewing, and editing for regulatory documents. Since January 2005, Susan has provided comprehensive support for various clients, focusing on clinical study protocols, regulatory submissions, and safety documents across multiple therapeutic areas including oncology and ophthalmology. Susan has collaborated with notable companies such as Sunesis Pharmaceuticals, Iovance Biotherapeutics, Merck, and Pfizer, ensuring high-quality deliverables through strong partnerships with regulatory affairs and multifunctional teams. Educationally, Susan holds a PhD in Medical Microbiology and Immunology from Wake Forest University School of Medicine and a Postdoctoral Fellowship in Internal Medicine.
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