Amy Attivissimo
Senior Regulatory Writer - Nonclinical @ Certara
About
Over 20 years of nonclinical report writing, project management, and toxicology experience. Experience in the management of toxicology research staff and studies, data handling and interpretation, toxicokinetic analysis and interpretation (utilizing Phoenix Winnonlin), project coordination/management, and familiarity with regulatory agency reporting requirements in a CRO environment. Well versed in Center of Veterinary Medicine (CVM) animal health study safety reporting and Module 4 nonclinical reports in multiple toxicology product lines including publishing, with additional experience in eCTD Module 2 nonclinical summaries, and IND/NDA regulatory reporting and submissions. Additionally, some experience with clinical documents such as protocols, amendments, patient narratives, and Investigator Brochures. Wilderness first responder educator, Nationally and Michigan State licensed WEMT-B, National Ski Patrol OEC, and University adjunct faculty. Life life to the fullest everyday. Go beyond.
United States
Greater Kalamazoo Area
Biotechnology
GLP, Toxicology, Pharmacology, FDA, Drug Discovery, Clinical Development, In Vivo, Clinical Research, Sop, Protocol, Laboratory, CRO, Quality Assurance, Immunology, Lifesciences, Life Sciences, Bioanalysis, Software Documentation, Research, Leadership
Experience

Senior Report Coordinator-General Toxicology and Infusion
Data review, handling, and interpretation. Technical writing and stat table generation for preclinical study reports. Project management and coordination internally and externally. Familiar with regulatory agency guidelines including but not limited to FDA GLP, CFR, OECD, EMEA, and animal health safety (CVM). Liaison for client comments and regulatory requests and internally between departments..

Senior Report Coordinator, Report Services -Kinetic Analysis
MPI Research
Mattawan, Michigan
•Point of coordination, project management, reporting, and communication for the Study Director (SD), Principle Investigator (PI), and/or Contributing Scientist (CS), clients, and internal multi-departmental groups, to ensure timeliness and accuracy of all study-based deliverables. •Ensure study designs are well-designed and accurate per client needs across internal departments including TK sample collection design in collaboration with the CS, SD, and client. Experience includes but is not limited to, general toxicology,DRF, MTD, and bioequivalence/biosimilar designs. •Operate and excel in a fast-paced and fast-moving environment, with demanding timelines for deliverables. Communicate both verbally and written at a high scientific level, manage and prioritize multiple clients, studies, protocols, interim and end of study reports, while aiding in the facilitation of new study designs, protocols, and reporting designs. Strong interpersonal/facilitation skills, and the ability to manage multiple studies and prioritize across competing resources. Proactive approach to all activities and the ability to drive successful internal departmental and client interactions. •Experience with writing and reporting in different formats for many governmental and international regulatory agencies including but not limited to FDA, EPA, OECD, and EMEA, and working regulatory agencies and audits. Proficient in Word and Adobe PDF creation and modification including hyperlinking and ISI toolbox customization (publishing team), specifically for customized reporting, client specific requests, and consultant report customization. •Proactive working style capable of both self-directed work and participation in multidisciplinary teams. Good problem identification and creative resolution aptitude. Biological research and drug development experience or knowledge and understanding. •Editing scientific interpretations and development and implementation of TK report writing training program.

Senior Report Coordinator, Report Services, Drug Safety Evaluation
MPI Research
Mattawan, Michigan
•Point of coordination, project management, reporting, and communication for the Study Director (SD), to ensure timeliness and accuracy of all study-based deliverables and reporting. •Ability to operate and excel in a fast-paced and fast-moving environment, with demanding timelines. Ability to communicate both verbally and written at a high scientific level, manage and prioritize multiple clients, studies, protocols, and reports, while aiding in the facilitation of new study designs, protocols, and reporting. Strong interpersonal/facilitation skills, and the ability to manage multiple studies and prioritize across competing resources. Proactive approach to all activities and the ability to drive successful internal departmental and client interactions. •Participate in internal study project meetings with multidisciplinary teams to plan for and communicate study approaches and deliverables like reports and tables. •Report writing in multiple disciplines-general toxicology, experimental therapeutics, immunology, safety pharmacology, surgery, and behavioral neuroscience. Attention to detail, design of customized reporting templates. •Writing and reporting in different formats for many governmental and international regulatory agencies including but not limited to FDA, EPA, OECD, and EMEA, and working with regulatory agencies and audits. Proficient in Word and Adobe PDF creation and modification including hyperlinking and ISI toolbox for customized reporting, client specific requests, and consultant report customization. Proficient in the creation, editing, QC and reviewing of data tables. •Proactive working style capable of both self-directed work and participation in multidisciplinary teams. Good problem identification and creative resolution aptitude. •Editing scientific interpretations, book and article chapters, posters and presentations, and scientific review of contributor reports. Toxicology reporting process and study coordination trainer.

Project Leader, Small Animal Toxicology, Laboratory Operations
MPI Research
Mattawan, Michigan
•Lead laboratory operations point of control for general toxicology and functional observational battery small animals preclinical studies. Scheduling and managing a variety of technicians study workloads and schedules in the overall design and implementation of all in-life study functions from antemortem to postmortem. Acted as a part-time technician to fill in gaps in the schedule. •Customer service and in-life project management across internal departments, SD, and clients, with respect to study function changes and timelines. •Data entry and job specific data handling skills, data review, QC, and data verification.

Research Associate II, Transgenics and Compound Preparation
PsychoGenics
Tarrytown, New York
•Performed all aspects of preclinical contract studies from start to reporting for specific clients regarding in-vivo efficacy drug discovery trials, phenotyping studies, and operant learning with transgenic rodents. Tasks included but were not limited to pharmacology equations, formulations, drug prep and solubility, dosing injections in transgenic mice (IP, PO, SC), surgical techniques, dosing logs, drug database, purchasing, decapitation, brain/plasma tissue harvest, toxic assessment and maximum tolerated dose, animal handling/weaning, notebook upkeep, and direct communication to clients. •Data entry (Excel, experimental database, Access, Stat View), statistics and job specific data handling skills and QC.

Inventory Allocation and Sizing
McMaster-Carr Industrial Supply
Elmhurst, Illinois
•Manage placement and allocation of inventory in conjunction with purchasing and supply chain personnel. •Mentally and physically demanding work in a very fast-paced environment. Various forklift certifications

Inventory Remerchandising & Customer Service
Dukes Ace Hardware
Burbank, Illinois
•Part-time building and updating inventory displays for two stores in conjunction with Ace’s Discovery Program. Customer service in all departments and labor intensive services

Graduate Assistant-Psychology Department and Mennonite School of Nursing
Normal, Illinois
•Assistant to a Dean of the Mennonite School of Nursing. Completing spreadsheets in Excel and stats in SPSS with real-time survey data. Other duties included: scheduling, writing surveys and contracts, library literature research and retrieval, secretarial work and organization. •Graduate assistant for Psychology professors. Tasks included grading papers and tests, proctoring exams, teaching lab sessions in SPSS, and test review sessions Design and run experimental trials in college students concerning dynamical systems theory and cognitive complexity of the human mind, and neurobehavioral/behavior/learning studies with rats
Education

Experimental Psychology - Cognitive and Behavioral Sciences
• Poster Presentation: “Dynamical Systems Theory and Complexity in College Students: Reaction Time Complexity Varies with Task Difficulty and Age” at the Graduate Research Symposia, Illinois State University (April 2003) • Poster Presentation and Thesis Defense Topic: “The Brain Under the Mane: Experimental Learning in Horses: Investigating a Matching-to-sample Task,” at the ABA National Research Conference, Boston, MA (May 2004) and the Graduate Research Symposia, Illinois State University (April 2004).
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