Boulder, Colorado, United States
In addition to the responsibilities of Clinical Evidence Associate: • Led the planning and creation of FDA-compliant clinical collaterals for a wide range of audiences. • Acted as subject matter expert on literature review and clinical data interpretation. • Led evidence review and clinical summary development for FDA annual reports and pre-submissions. • Helped develop product claims and identify competitive differentiators. • Acted as Clinical Affairs lead on teams for new product initiatives and cross-functional product management. • Ensured scientific accuracy of marketing and medical education collaterals and presentations. • Prepared targeted clinical summaries for executive leadership and potential investors. • Cross-functionally communicated and planned responses to new publications, literature trends, and competitive developments. • Supported medical reimbursement and market access efforts. • Managed medical information requests.
• Created evidence-based marketing and sales white papers for both internal and external audiences. • Created clinical literature summaries for US regulatory submissions. • Assisted Clinical Evaluation Report (CER) writing. • Leveraged PubMed and Embase to create a Clinical Bibliography cataloging internal and external publications on ZimVie Spine medical devices and biologics. • Conducted literature reviews to support product launches and Marketing, Sales Education, Regulatory Affairs, and Research & Development needs. • Provided editing and journal submission support for scientific manuscripts. • Created slide decks for congress presentations.
Performed lab work and data analysis supporting studies on the effects of intrauterine growth restriction on the fetal liver. This included: · Western Blot, PCR, and cell culture. · Analyzing data in Excel and visualizing data in GraphPad Prism. · Literature review. · Managing experiment timelines.
• Supported continuous safety surveillance and root cause analysis studies of serious adverse events associated with the pediatric use of oral cough and cold medicine and pediatric and adult use of acetaminophen. • Managed the identification and review of news media and medical literature related to study drugs. • Created and maintained citation databases within EndNote. • Reviewed outgoing client reports. • Abstracted medical record data into the Research Electronic Data Capture (REDCap) database, translating lengthy case narratives into quantifiable data points. • Managed the processing of National Poison Data System case alerts and records, coordinating with multiple poison centers to ensure data quality and training new employees on the process.
• Investigated the effect of vitamin K and co-enzyme Q on cleavage rates and developmental potential of murine embryos in an in vitro fertilization setting. • Reviewed scientific literature concerning embryology, endocrinology, bioethics, and assisted reproductive technologies (ARTs), condensed the information into succinct reports, and led class presentations on the subject matter. • Practiced a wide range of ARTs, including in vitro fertilization, gamete cryopreservation, embryo biopsy, and intracytoplasmic sperm injection.
• Investigated the expression pattern of transcription factors on the HC11 mammary cell line. • Experiments and laboratory work included preparation and changing of growth and differentiation medias, RNA extraction, protein assays, iScript cDNA synthesis, qPCR, Western Blot, and SDS-PAGE.