AbbVie Scientist, Toxicology in Lake County, Illinois

Scientist, Toxicology

USA, Illinois, Lake County

Research & Development

Requisition #1804611

Candidate will prepare SEND datasets and nonclinical documents for regulatory submission.

Technical preparation ofdatasets:

  • Prepare timely, FDA compliant SEND datasets, definefiles and Study Data Reviewer’s Guides

  • Understand and comply with Regulatory guidancedocuments used in dataset preparation

  • Understand and comply with FDA business rules used indataset preparation

  • Capably use software and other tools to createcompliant datasets and domains

 

Troubleshooting andquality control of dataset packages:

  • Integrate knowledge of AbbVie study conduct to assurecorrect dataset output

  • Knowledgably interact with study personnel as needed toprepare, review and troubleshoot dataset packages

  • Use knowledge of Regulatory requirements and Toxicologystudy conduct to resolve and/or provide rationale for validation errorsand warnings

  • Communicate findings to team members and management

  • Prepare Study Data Reviewer’s Guide

  • Manage marketing application sections duringpreparation period; filing team SME participant

  • Define and communicate deliverables, quality targetsand timelines

  • Develop Toxicology study knowledge/ expertise

  • Stay current with changing Regulatory requirements andindustry norms

Technical expertise:

  • Process protocols, reports,submission documents and other documents, as assigned and on a timelybasis

  • In-depth knowledge of MS Word

  • Ensure high quality compilationand QC of Pathology, Toxicology, Genetic Toxicology, and other reportswithin specified timelines.

  • Create Virtual Document ofreport and M4 of Regulatory Submissions to assist in quick compilationcompletion.

Content knowledge:

  • Prepare early drafts ofToxicology Reports, Toxicology sections of INDs and NDAs, ToxicologyTabulations, Abstracts, IND Annual Reports.

  • Ensure issuance and correctdistribution of all protocols and amendments

  • Knowledge of where reports andsubmission documents fit into regulatory submissions

  • Coordinates and assists withpreparation of JNDA inventories and GLP Compliance Statements

Quality Control:

  • Key responsibility is draftingand quality control checks of all assigned document content within definedstandards (non-scientific)

  • Accountable for Quality Controlchecks of regulatory documents, etc. for consistency and errors perprocess

  • Creates and QCs Toxicologysections of submission planners for Regulatory submissions

  • Accountable for Quality Controlchecks of Regulatory submissions in eCTD Express

  • Actively maintain timelines forreports and submissions by tracking timelines for submission documents,and reports and their components. Works proactively with authors andproject reps to meet deadlines.

  • Produce finished documents in atimely and organized manner

  • Provide support and help ensureuser testing is conducted for system upgrades

  • Maintains document andsubmission tracking for all documents

  • Routinely engages managementfor issue and timeline status, quality and/or content questions

Competencies:

  • People leadership, collaboration andteamwork skills necessary for small team and external businessinteractions/communications

  • Understanding of Toxicology or relatednonclinical study conduct and design as it relates to data in submissionpackage. GLP (or related regulatory environment) experience preferred.

  • Ability to work independently whilecontributing as an effective, collaborative team member

  • Resolution oriented- uses reasoning totroubleshoot and provide possible solutions to issues regardless oforigin, relentlessly seeks root cause of issues

  • Gathers appropriate backgroundquickly, seeks input of subject matter experts and management, proposessolutions

  • Experienced and facile with computersystems and software.

  • Works with a proactive mindset,prepares and communicates an action plan and potential issues - must beable to provide services and results on time, accurately and consistentwith expectations

  • Must demonstrate and consistently useexcellent communication skills, both verbal and written. Ability tocommunicate complex, technical issues clearly

  • Ability to prioritize multipletasks/projects and strong organizational skills against managementprovided information

  • Seeks management input when needinginformation, doesn’t jump to "that’s the way we always do it"

  • Detail oriented while understandingand acting against the "big picture"

  • Must demonstrate and consistently useexcellent interpersonal skills

  • Ability to integrate and retain newinformation quickly (quick learner)

  • Abile to act as a change agent: systemupgrades and migrations, business process improvements, prioritymanagement

Basic:

  • Bachelor of Science Degree in Biology or related field required

  • At least five years’ experience supporting nonclinical research and development in the pharmaceutical industry preferred

Equal Opportunity Employer Minorities/Women/Veterans/Disabled