A BDN client is looking for a Medical/Technical Writer who has a background with genetic sequencing. This role is not working on submissions but will be working on writing for clinical utility protocols and validation studies. IVD products will be classified as a Medical Device, but the client needs a consultant who has a strong scientific background with genetic sequencing experience. An IVD background is a plus; Scientific knowledge is vital for this position. This candidate will be working on synthesizing validation data from the IVD team into presentable summaries. Some data integrity, editing, and review are needed along with protocol reports and documentation review, including statistical reports. The most critical task will involve technical writing for validation studies. The second most crucial task area will be medical writing. Writing clinical utility protocols and evidence-based value analysis is needed. Experience with genetic sequencing assays, reviewing literature, as well as experience writing analytical validation and protocol/reports, is desired Evaluating data for accuracy, reproducibility, precision, and sensitivity is required. The client is looking for candidates with 7 or more years of medical and technical writing experience for this role. Experience with Japan’s (PMDA/MHLW) and USA’s (FDA/CMS) is essential. He/she will need to have experience in writing validation and/or technical documentation for diagnostic assays & experience developing and synthesizing data summaries, tables, digests, and/or data presentations. An advanced Scientific degree is required (e.g., M.S., PhD., or PharmD).