Amy Attivissimo

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.

Country

United States

City

Greater Kalamazoo Area

Industry

Biotechnology

Skill

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

Certara

Senior Regulatory Writer - Nonclinical

Certara

LinkedIn
2023-3 - Present · 3 yrs 7 mos

United States

Wilderness Medical Associates International

Lead Instructor

Wilderness Medical Associates International

LinkedIn
2016-5 - Present · 10 yrs 5 mos

Teach wilderness medical courses from 2 to 8 days depending on certification desired.

MMS

Medical Writer II

MMS

LinkedIn
2021-11 - 2022-8 · 10 mos

Remote

Grand Valley State University

Adjunct Faculty Instructor

Grand Valley State University

LinkedIn
2020-8 - 2022-8 · 2 yrs 1 mo

Allendale, Michigan, United States

Instructor in Outdoor Education skills in a University Environment. Familiar with Blackboard, Banner, and various Microsoft applications.

Charles River Laboratories

Senior Report Coordinator-General Toxicology and Infusion

Charles River Laboratories

LinkedIn
2019-1 - 2021-11 · 2 yrs 11 mos

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..

Charles River Laboratories

Senior Report Coordinator

Charles River Laboratories

LinkedIn
2006-11 - 2021-11 · 15 yrs 1 mo

Kalamazoo, Michigan Area

MPI Research

Senior Report Coordinator, Report Services -Kinetic Analysis

MPI Research

2013-6 - 2021-11 · 8 yrs 6 mos

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.

MPI Research

Senior Report Coordinator, Report Services, Drug Safety Evaluation

MPI Research

2008-5 - 2013-6 · 5 yrs 2 mos

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.

MPI Research

Project Leader, Small Animal Toxicology, Laboratory Operations

MPI Research

2006-11 - 2008-5 · 1 yr 7 mos

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.

PsychoGenics

Research Associate II, Transgenics and Compound Preparation

PsychoGenics

2005-8 - 2006-10 · 1 yr 3 mos

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.

McMaster-Carr Industrial Supply

Inventory Allocation and Sizing

McMaster-Carr Industrial Supply

2004-11 - 2005-8 · 10 mos

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

Dukes Ace Hardware

Inventory Remerchandising & Customer Service

Dukes Ace Hardware

1999-5 - 2005-3 · 5 yrs 11 mos

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

Illinois State University

Graduate Assistant-Psychology Department and Mennonite School of Nursing

Illinois State University

LinkedIn
2002-8 - 2004-5 · 1 yr 10 mos

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

Illinois Wesleyan University

Illinois Wesleyan University

LinkedIn

Psychology

1998 - 2002 · 4 yrs

• Poster Presentation: “Demand Elasticity and Commodity Substitutability in a Simulated Economy” at the John Wesley Powell Research Conference, Illinois Wesleyan University (May 2002)

Illinois State University

Illinois State University

LinkedIn

Experimental Psychology - Cognitive and Behavioral Sciences

2002 - 2004 · 2 yrs

• 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).

Amy Attivissimo's Contact Information

Email

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Phone

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