Strategic Program Champion
Dana Blue, M.S., is a Strategic Program Champion at Facet Life Sciences, a company designed to assist small to mid-sized pharmaceutical companies develop, register and maintain drug, biologic, device and generic applications. Dana has approximately 20 years of pharmaceutical experience in a variety of positions ranging across the entire pharmaceutical product life cycle (development to retirement). For the past 10+ years, Dana has worked as a Medical Writer and her background includes clinical planning, development of clinical and device study documentation, and submission authoring including M1, M2, and M5 for US, EU and HC submissions.
Dana started her career at Cook Imaging (now Baxter Scientific) as a Research and Development Chemist. While there, Dana developed and validated analytical methods to be used for in-process and stability-indicating testing. She was responsible for writing validation protocols, reports for potency, stability indicating assays, and equipment release assays.
In 2001, Dana joined Eli Lilly and Company (Lilly) as a Quality Control / Assurance Floor Representative for parenteral manufacturing. In this role, Dana provided daily support for formulation, filling, capping, inspection, lyophilization, labeling, packaging, and storage.
In 2006, while still at Lilly, Dana changed roles and became a Senior Medical Writer. While in this role, Dana was responsible for clinical study documentation, including protocols, CSRs, “right-to-operate” documentation (IB, annual reports, IMPD, safety updates) as well as M2 and M5 submission documentation. In 2004, Dana was requested for support with device development and testing initiatives and was recognized as the Clinical Device SME in 2011. In 2012, Dana was promoted to Associate Consultant Medical Writer. In addition to her former responsibilities, she was now also responsible for creating and maintaining Clinical Plan Documents, Value Plans and Launch Labels for all endocrine products (drug and device).
Most recently, Dana was a Senior Medical Writer (Business Process Outsourcing) at CSC. While there, Dana worked on protocols and protocol amendments for rare autoimmune diseases. She also managed and authored a 505(b)(2) OTC submission and assisted with M3 documentation for a biological product.