Experience

Greenfield Pathology Services, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Research Assistant - Pathology

  • Apr 2022 - Present



Charles River Laboratories

• United States
• Biotechnology Research
• 700 & Above Employee

• Senior IT Analyst - SEND

  • Aug 2017 - Apr 2022

  Ashland, Ohio USA  Create SEND datasets for electronic submissions per client request and team needs. Create and QC trial designs per study plan and SEND IG  Fluently use Centrus Submit Requestor tool to extract study data for visualization in Excel.  Collaborate globally to ensure deliverables are met timely  Import datasets using Viewer in order to Validate in Pinnacle 21-then determine and resolve program- designated flags for regulatory compliance  Ensure dataset aligns with appropriate… Show more  Create SEND datasets for electronic submissions per client request and team needs. Create and QC trial designs per study plan and SEND IG  Fluently use Centrus Submit Requestor tool to extract study data for visualization in Excel.  Collaborate globally to ensure deliverables are met timely  Import datasets using Viewer in order to Validate in Pinnacle 21-then determine and resolve program- designated flags for regulatory compliance  Ensure dataset aligns with appropriate SEND IG and controlled terminology version  Verify extracted study data are accurate and align with study report and applicable regulations  Adhere to company determined priority shipping schedule  Creating Access database to enable efficient terminology definition confirmation Show less



Eli Lilly and Company

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Associate - Operations - Quality Review

  • Jun 2014 - Aug 2017

  Indianapolis, Indiana Area Lead Quality Review group; quality review documents submitted to regulatory agencies including eCTD written summaries and tabulated summaries, briefing documents, regulatory responses, IBs, risk profiles, PSUR/DSURs, DRMPs, PIPs, etc., drug disposition clinical documents such as clinical pharmacology summaries and appendices, method validations, as well as environmental assessments; quality review manuscripts; coordinate quality review assignment workload; Create and maintain training… Show more Lead Quality Review group; quality review documents submitted to regulatory agencies including eCTD written summaries and tabulated summaries, briefing documents, regulatory responses, IBs, risk profiles, PSUR/DSURs, DRMPs, PIPs, etc., drug disposition clinical documents such as clinical pharmacology summaries and appendices, method validations, as well as environmental assessments; quality review manuscripts; coordinate quality review assignment workload; Create and maintain training documentation and metrics; coordinate international metrics for nonclinical submissions; prepare and report requested and required metrics; collaborate with international partners on quality review projects.

• Senior Operations Associate -Nonclinical Submissions

  • May 2013 - May 2014

  Indianapolis, Indiana Regulatory Formatting Prepare ADME, Discovery and CRO Documents using internal and commercial tools for submissions to regulatory agencies for INDs, NDAs, special projects (e.g. create regulatory information center on internal collab site); create educational materials; coordinate submission with lead scientists and regulatory scientists/associates from authoring to submission for adherence to timeline and regulatory parameters; maintain periodical and right-to-operate submissions.



Covance

• United States
• Research Services
• 700 & Above Employee

• Report Coordinator III

  • Mar 2011 - May 2013

  Greenfield, Indiana Coordinate, generate, organize, format, and edit data tables for Developmental and Reproductive Toxicology, and GeneTox (GT) studies (GLP environment); Quality Review GT Reports; Maintain and track Standard Operating Procedure (SOP) reading compliance Respond to and resolve Quality Assurance audit findings Transition and incorporate SOPs into cutting-edge technology SOP-training tool Submit report surveys to clients following report finalization Complete template protocols and/or… Show more Coordinate, generate, organize, format, and edit data tables for Developmental and Reproductive Toxicology, and GeneTox (GT) studies (GLP environment); Quality Review GT Reports; Maintain and track Standard Operating Procedure (SOP) reading compliance Respond to and resolve Quality Assurance audit findings Transition and incorporate SOPs into cutting-edge technology SOP-training tool Submit report surveys to clients following report finalization Complete template protocols and/or reports as needed by Study Directors Show less