Description
Summary Work Experience: Strong background in medical writing and biotechnology product and services development, with a solid publication record in the peer-reviewed medical literature in addition to biotechnology analyst articles-an unusual combination of medical writing expertise, analytical skills, data analysis, management experience, and medical knowledge. Participate in pre-clinical, clinical, and commercial research and development of drug, biologic, wellness, and medical device products. Manage medical writing projects, mentor and develop junior researchers, perform laboratory research and development, conduct product testing and diagnostics, instruct university courses in biology, consult clients, and build clinical data structures, trend analysis via artificial intelligence, and dashboard presentation. Writing Experience: Write, edit, and review NIH and public foundation grant proposals, peer review journal submissions, pre-clinical research reports, clinical study reports (CSRs), patent application content, DQR, white papers, and over 100 biotechnology investment articles. Write, edit, and review ICH-compliant US regulatory submissions (including one IND, Pre-NDA, NDA/sNDAs, Pre-BLA, several 510Ks, 1 combination drug/device submission, and SOPs. Evaluate clinical study protocols and amendments serious adverse event (SAE) and adverse event (AE) narratives efficacy analysis internal reports labels, speaker bureau surveys and reports, and web site content. * Medical writing experience includes wound healing, allergy and inflammation, cardiovascular dynamics, immunology, infectious disease, oncology opthamology pediatric and adult neurology drug, biologic, and medical device development and more. * Example indications include acute myeloid leukemia (AML), age-related macular degeneration (AMD), Alzheimers (AD), anemia, atherosclerosis, breast cancer (BC), chronic kidney disease (CKD), coronary artery disease (CAD), Crohn disease, epilepsy, graft-versus-host disease (GVHD), hepatitis B&C, HIV/AIDS, influenza virus infection, multiple sclerosis (MS), multiple myeloma, non-Hodgkin lymphoma (NHL), non-small-cell lung cancer (NSCLC), pancreatic cancer, rare disease genomic targets, renal failure, restenosis, soft tissue sarcoma (STS), wound repair, and others. Experienced with biosimilars and biobetters. * Participated in medical writing groups at one biotechnology company, three biotechnology business development companies, and 1 clinical research organization (CRO). Experience developing quality review processes for clinical and regulatory documents. Extensive medical writing project management experience. * Broad drug, biologic, and medical device product development experience, from discovery and preclinical through clinical research, postmarketing, process development, and manufacturing/CMC. * Extensive program design in health and wellness track metrics and programs for clients. Strong background in medical writing and biotechnology product and services development with a solid publication record in the peer-reviewed medical literature in addition to biotechnology analyst articles-an unusual combination of medical writing expertise analytical skills data analysis management experience and medical knowledge. Participate in pre-clinical clinical and commercial research and development of drug biologic wellness and medical device products. Manage medical writing projects mentor and develop junior researchers perform laboratory research and development conduct product testing and diagnostics instruct university courses in biology consult clients and build clinical data structures trend analysis via artificial intelligence and dashboard presentation. Major Accomplishments: Published 5 peer-reviewed articles two in polyunsaturated fatty acid (PUFA) and cholesterol/tocopherol lipid membrane biophysics journals, and three articles in molecular neurobiology implicated in seizure and stroke. Assisted John W McDonald, M.D., Ph.D. in stem cell transplant research and review articles for spinal cord injury (SCI) on Christopher Reeve Foundation SCI team. Contributed to several 510K submissions that were approved by FDA at Med Institute (1) Catheter (2) Paclitaxel-coated Stent (3) SIS cardiovascular graft with PTFE predicate (4) SIS wound healing. Re-established CLIA-certified laboratory facility to continue mammastatin research and development project, SOPs, and IND review after FDA halted phase 1 trial at Biotherapies, Inc. prior to arrival.
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