Ariel Ortiz Email & Phone Number

Minneapolis, Mn, Us

New York, Us

Accumulated experience of leading a group of people and acting as a fair and communicable authority and mentoring figure to my fellow coworkers-In charge of manager functions such as providing solutions for problems that arise, monthly inventory, providing leadership and a good example to my fellow employees and coordinating the daily functions of the café. -Trains newly hired workers on company policies and procedures.

Indianapolis, Indiana, Us

Keck Graduate Institute Team Master's Project, "Innovative Regulatory Technologies". Sponsored by Eli Lilly-Researching new opportunities in regulatory intelligence-Surveying experts on the current regulatory landscape

Claremont, Ca, Us

Keck Graduate Institute Writing an Orphan Drug Application Project-Authored an orphan drug designation application for Krabbe's Disease in accordance to FDA standards-Created a clinical strategy and reasoning for the development of a potential therapy for Krabbe's Disease

Claremont, Ca, Us

Keck Graduate Institute Development of a Pharmaceutical Quality System Project-Drafted CAPA investigational plan to address potential drug and biologics recall strategies - Developed a pharmaceutical quality system approach in accordance to a Quality Manual and regulatory authorities' standards

Dublin, Coolock, Ie

Accumulated a strong background in understanding the importance of the continuous need to improve clinical study development procedures to better improve therapeutic effectiveness on medical conditions as well as helping to implement some of those therapeutics with patients. -Authored an Investigator’s Brochure -Mentored a Pharmacy Student-Assisted team with study start up activities for identified studies -Clinical Scale Development, FDA Type C Meeting Materials, Literature Review, Investigator Protocol Training Material

Claremont, Ca, Us

Keck Graduate Institute Design of Clinical Trial Project-Created a mock informed consent document, timeline of study progression, and recruitment media for a clinical trial recruitment presentation

Claremont, Ca, Us

Keck Graduate Institute Biosimilar Development Project-Collaborated with a team of students to create a mock biosimilar-Researched relevant regulatory pathways (NDA)-Presented to a faculty panel the viability and the potential commercialization of the biosimilar

Claremont, Ca, Us

Keck Graduate Institute Medical Device Development Project-Reviewed 250 predicate devices 510ks-Created a mock 510k submission for a proposed Digoxin medical device-Assured that device analytical data fell within CLSI, CEN, & ISO standards -Calculated device’s accuracy, precision, specificity, and sensitivity

Scottsdale, Arizona, Us

Keck Graduate Institute: Market Research Project, "Water Sterility Assurance System", sponsored by Verrix-Determined the governing regulations for the company’s proposed technology -Assessed the proposed technology’s market potential

Irvine, Ca, Us

I was a part of UC Irvine's Public Health ICTS Clinical & Transitional Research Preparatory Program, which enables students to receive first-hand experience in research labs. I observed and assisted in the lab of Dr. David Reinkensmeyer's FINGER robot research project, which involved robotic rehabilitation for patients with upper limb and extremities paralysis. -Responsible for explaining research objectives and procedures to potential participants.-Collaborated with study physical therapist to run therapy sessions with patients and the robotic exercise equipment-Gained consent from participants and engage with them in the FINGER robot clinical research lab at UCI. -Well-trained in HIPAA protocol, IRB protocol and Environmental Health & Safety

Minneapolis, Mn, Us

National Marrow Donor Program-Southwest Division-Organized and acted as coordinator for bone marrow drives-Acted as ambassador to spreading knowledge about bone marrow registration and donation

Masters Of Business & Sciences, Clinical & Regultory Affairs

Bachelor Of Science (B.S.), Public Health